AsthmaPhase 2NCT01453296

Pharmacokinetics and Pharacodynamics of GW642444 in Paedetric Subjects

A Phase 2 study testing GW642444 in people with Asthma, run by GlaxoSmithKline at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This study will investigate the effect of dosing paedeatric asthmatic subjects with GW642444, an orally inhaled long-acting agonist of the β2-adrenoceptor. Read more about this study

Who is it for?: Ages 5 to 11 years
Conditions the study is for: Asthma
What is being tested?: GW642444
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 28 participants
Where: 5 sitesUnited States
Study dates: Aug 2010to Apr 2011
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 5 to 11 years
All sexes
No healthy volunteers
Child

Who may be able to join

Male and pre-menarchial female subjects aged 5-11 years on the last planned treatment day are eligible for this study. Pre-menarchial females are defined as any female who has yet to begin menses and is considered Tanner Stage 2 or less.
Diagnosis of asthma at least 6 months prior to screening.
Patients must be controlled on their existing asthma treatment at Screening as defined by a Childhood Asthma Control Test score of >19 and PEF (Peak Expiratory Flow) >75 % predicted.
Subjects must be taking a stable regimen of fluticasone propionate (≤200 μg (micrograms) twice daily or equivalent) and short acting beta-agonist inhaler on an as-need basis for at least 4 weeks prior to screening.
Apart from asthma, eczema and rhinitis, subjects should be healthy and suffer from no other significant medical conditions.
Subjects must weigh at least 15 kg (kilograms).

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Subjects must demonstrate ability to accept and effectively use the GW642444 device using the demonstration kits provided to the site.
The subject and parent or guardian are able to understand and comply with protocol requirements, instructions, and protocol-stated restrictions. The parent or guardian must have the ability to read, write and record diary information collected throughout the study. The parent or guardian must also have the ability to manage study drug administration and PEF assessments.
At least one parent or guardian has signed and dated the written informed consent prior to admission to the study. This will be accompanied by informed assent from the subject.

Who cannot join

Subjects currently receiving (or have received within 4 weeks of screening) any of the following asthma therapies: theophyllines, long-acting inhaled beta-agonists, oral beta-agonist.
Subjects who have changed their asthma medication within 4 weeks of screening.
Clinical visual evidence of oral candidiasis at screening.
Any clinically relevant abnormality identified on the screening medical assessment
Any medical condition or circumstance making the subject unsuitable for participation in the study (e.g. history of life-threatening asthma)
Asthma exacerbation requiring systemic corticosteroids (oral, intramuscular, intravenous) or Emergency Room attendance within 3 months or asthma exacerbation requiring hospitalization within 6 months prior to the screening visit.

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Culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract which is not resolved within 4 weeks of the screening visit.
Any adverse reaction including immediate or delayed hypersensitivity to any betaagonist therapy.
Known or suspected sensitivity to the constituents of the novel dry powder inhaler (i.e., lactose or magnesium stearate), for example, history of severe milk protein allergy.
The parent or guardian has history of psychiatric disease, intellectual deficiency, substance abuse, or other condition (e.g., inability to read, comprehend or write) which will limit the validity of consent to participate in this study.
A subject will not be eligible for this study if he/she is an immediate family member of the participating Investigator, sub-Investigator, study coordinator, or employee of the participating Investigator.
Children who are wards of the state or government.
Evidence of clinically significant abnormality in the 12-lead ECG (electrocardiogram) at Screening

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

GSK Investigational Site
Cypress, California, 90630
GSK Investigational Site
Denver, Colorado, 80206
GSK Investigational Site
Huntington Beach, California, 92647
GSK Investigational Site
Medford, Oregon, 97504
GSK Investigational Site
Normal, Illinois, 61761

Other trials in United States

About this study

Official title: A Randomized, Double-blind, Placebo-controlled, Two-way Crossover 7-day Study to Investigate the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Repeat Dose Inhaled GW642444 25 μg (Micrograms) in Children Aged 5-11 Years With Persistent Asthma.

This study will investigate the effect of dosing paedeatric asthmatic subjects with GW642444, an orally inhaled long-acting agonist of the β2-adrenoceptor.

Read the detailed description

This study will investigate the effect of dosing with 25 μg GW642444, an orally inhaled long-acting agonist of the β2-adrenoceptor, in asthmatic subjects aged 5 to 11. GW642444 is currently under development as the long-acting beta-agonist component of a combination product containing an inhaled corticosteroid and a longacting beta-agonist.

Subjects will receive a single dose via a novel dry powder inhaler, then 7 days once-daily repeat dosing following a washout period. The study will be a randomized two-way crossover, with a placebo control. Approximately 26 subjects will be recruited to this study, with the aim that 20 will complete the study. Safety, tolerability, pharmacokinetics and glucose and potassium levels will be investigated.

Conditions: Asthma
Being tested: GW642444, Placebo
Keywords: Asthma, Tolerability, Safety, Pharmacokinetics, GW642444
Medical subject headings: Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GW642444Drug
GW642444 25 μg; Novel dry powder inhaler
PlaceboDrug
Matching placebo; Novel dry powder inhaler

Study groups in NCT01453296
Study group	Role	What they receive
COHORT 1 (RANDOMISATION AB or BA)	Active comparator	8-11 years old; Subjects will be assigned to receive GW642444 25μg or matching placebo (in a 1:1 ratio) in an AB or BA (A= GW64244, B= Placebo) sequence. Following randomisation (AB or BA) subjects will receive a single dose treatment, followed by 7 day washout period. This will then be followed by a repeat dose session of the same treatment (Day 8 and Day 14 in house, Days 9-13 at home). Each subject will then complete the same sequence for the alternative treatment in the second session. There will be a washout period of at least 7 days between the treatment periods. Receives: Drug: GW642444; Drug: Placebo
COHORT 2 (RANDOMISATION AB or BA)	Active comparator	5-7 years old. Subjects will be assigned to receive GW642444 25μg or matching placebo (in a 1:1 ratio) in an AB or BA (A= GW64244, B= Placebo) sequence. Following randomisation (AB or BA) subjects will receive a single dose treatment, followed by 7 day washout period. This will then be followed by a repeat dose session of the same treatment (Day 8 and Day 14 in house, Days 9-13 at home). Each subject will then complete the same sequence for the alternative treatment in the second session. There will be a washout period of at least 7 days between the treatment periods. Receives: Drug: GW642444; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) During the Treatment Period
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Medical or scientific judgment should be exercised in deciding whether reporting is appropriate in other situations. Refer to the General AE/SAE module for a complete list of AEs and SAEs.
Measured: From the start of study medication until Week 11 (Visit 8)/Early Withdrawal
Basophil, Eosinophil, Lymphocyte, Monocyte, Total Neutrophil, Platelet, and White Blood Cell Count Values at Day 14 of the Respective Treatment Period
Blood samples were collected for the measurement of basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelets, and white blood cell (WBC) count at Day 14 of the respective treatment period. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg.
Measured: Day 14 of the respective treatment period (up to Study Day 49)
Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Values at Day 14 of the Respective Treatment Period
Blood samples were collected for the measurement of hemoglobin and MCHC at Day 14 of the respective treatment period. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg.
Measured: Day 14 of the respective treatment period (up to Study Day 49)
Reticulocyte and Red Blood Cell (RBC) Values at Day 14 of the Respective Treatment Period
Blood samples were collected for the measurement of reticulocytes and RBCs at Day 14 of the respective treatment period. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg.
Measured: Day 14 of the respective treatment period (up to Study Day 49)
Hematocrit Value at Day 14 of the Respective Treatment Period
Blood samples were collected for the measurement of hematocrit at Day 14 of the respective treatment period. Hematocrit is a measure of the percentage of the volume of the whole blood that is composed of red blood cells, as determined by separation of red blood cells from the plasma (usually by centrifugation). Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg.
Measured: Day 14 of the respective treatment period (up to Study Day 49)
Mean Corpuscle Volume (MCV) Value at Day 14 of the Respective Treatment Period
Blood samples were collected for the measurement of MCV at Day 14 of the respective treatment period. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg.
Measured: Day 14 of the respective treatment period (up to Study Day 49)
Mean Corpuscle Hemoglobin (MCH) Value at Day 14 of the Respective Treatment Period
Blood samples were collected for the measurement of MCH at Day 14 of the respective treatment period. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg.
Measured: Day 14 of the respective treatment period (up to Study Day 49)
Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), and Gamma Glutamyl Transferase (GGT) Values at Day 14 of the Respective Treatment Period
Blood samples were collected for the measurement of ALT, ALP, AST, and GGT at Day 14 of the respective treatment period. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg.
Measured: Day 14 of the respective treatment period (up to Study Day 49)
Albumin and Total Protein Values at Day 14 of the Respective Treatment Period
Blood samples were collected for the measurement of albumin and total protein at Day 14 of the respective treatment period. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg.
Measured: Day 14 of the respective treatment period (up to Study Day 49)
Calcium, Chloride, Carbon Dioxide (CO2) Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) Values at Day 14 of the Respective Treatment Period
Blood samples were collected for the measurement of calcium, chloride, carbon dioxide content/bicarbonate (CO2/BI), glucose, potassium, sodium, and urea/BUN at Day 14 of the respective treatment period. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg.
Measured: Day 14 of the respective treatment period (up to Study Day 49)
Total Bilirubin, Direct Bilirubin, Creatinine, and Uric Acid Values at Day 14 of the Respective Treatment Period
Blood samples were collected for the measurement of total bilirubin, direct bilirubin, creatinine, and uric acid at Day 14 of the respective treatment period. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg.
Measured: Day 14 of the respective treatment period (up to Study Day 49)
Peak Expiratory Flow on Day 1, Day 8, and Day 14 of the Respective Treatment Period
Peak Expiratory Flow (PEF) is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF is calculated as the maximum of three readings taken at each timepoint for each participant. Baseline is defined as the pre-dose measurement at Day 1 for the respective period. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg (n=28).
Measured: Day 1, Day 8, and Day 14 of the respective treatment period (up to Study Day 49)
Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Day 1, Day 8, and Day 14 of the Respective Treatment Period
SBP and DBP were measured at Day 1, Day 8, and Day 14 of the respective treatment period. PD=post-dose. Baseline is defined as the pre-dose measurement at Day 1 for the respective period. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg (n=28).
Measured: Day 1, Day 8, and Day 14 of the respective treatment period (up to Study Day 49)
Maximum Heart Rate at Day 1 and Day 14 of the Respective Treatment Period
Heart rate (HR) was measured at Day 1 and Day 14 of the respective treatment period. hr=hour. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg (n=28).
Measured: Day 1 and Day 14 of the respective treatment period (up to Study Day 49)
Weighted Mean Heart Rate at Day 1 and Day 14 of the Respective Treatment Period
Heart rate (HR) was measured at Day 1 and Day 14 of the respective treatment period. hr=hour. Weighted means were derived using the linear trapezoidal rule. Actual relative times were used for the calculation except where actual times were missing. If any actual times were missing, planned relative times were used for these observations. For 0-8 hr parameters, treatment, period, participant Baseline, and period Baseline were fitted as fixed effects, and participant was fitted as a random effect. For 0-2 hr parameters, treatment, period, day (1 and 14), participant Baseline, period Baseline, and treatment*day interaction were fitted as fixed effects, and participant was fitted as a random effect. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg (n=28).
Measured: Day 1 and Day 14 of the respective treatment period (up to Study Day 49)
Maximum QTcF at Day 1 and Day 14 of the Respective Treatment Period
The electrocardiographic (ECG) parameter QT duration corrected using Fridericia's formula (QTcF) was measured at Day 1 and Day 14 of the respective treatment period. hr=hour. For 0-8 hr parameters, treatment, period, participant Baseline, and period Baseline were fitted as fixed effects, and participant was fitted as a random effect. For 0-2 hr parameters, treatment, period, day (1 and 14), participant Baseline, period Baseline, and treatment*day interaction were fitted as fixed effects, and participant was fitted as a random effect. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg (n=28).
Measured: Day 1 and Day 14 of the respective treatment period (up to Study Day 49)
Weighted Mean QTcF at Day 1 and Day 14 of the Respective Treatment Period
The electrocardiographic (ECG) parameter QT duration corrected using Fridericia's formula (QTcF) was measured at Day 1 and Day 14 of the respective treatment period. hr=hour. Actual relative times were used for the calculation except where actual times were missing. If any actual times were missing, planned relative times were used for these observations. For 0-8 hr parameters, treatment, period, participant Baseline, and period Baseline were fitted as fixed effects, and participant was fitted as a random effect. For 0-2 hr parameters, treatment, period, day (1 and 14), participant Baseline, period Baseline, and treatment*day interaction were fitted as fixed effects, and participant was fitted as a random effect. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg (n=28).
Measured: Day 1 and Day 14 of the respective treatment period (up to Study Day 49)

Secondary outcomes (13)

AUC(0-t) and AUC(0-8) on Day 14 of the Respective Treatment Period
Area under the concentration-time (AUC) curve from time zero (pre-dose) to the last time AUC(0-t) and from time zero to 8 hours AUC(0-8) of quantifiable concentration of VI on Day 14 of the respective treatment period was measured. Samples were collected at the following times: pre-dose; 10 minutes (min) and 30 min post-dose; and 1, 2, 4, 6, and 8 hours post-dose for participants who were >=20 kilograms and pre-dose; 10 min and 30 min post-dose; and 1, 2, and 4 hours post-dose for participants who were <=20 kilograms on Day 14 of the respective treatment period. Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the Pharmacokinetic Population.
Measured: Day 14 of the respective treatment period (up to Study Day 49)
Cmax on Day 14 of the Respective Treatment Period
Cmax is defined as the maximum observed concentration on Day 14 of the respective treatment period. Samples were collected at the following times: pre-dose; 10 minutes (min) and 30 min post-dose; and 1, 2, 4, 6, and 8 hours post-dose for participants who were >=20 kilograms and pre-dose; 10 min and 30 min post-dose; and 1, 2, and 4 hours post-dose for participants who were <=20 kilograms on Day 14 of the respective treatment period.
Measured: Day 14 of the respective treatment period (up to Study Day 49)
Tmax, t1/2, and t at Day 14 of the Respective Treatment Period
tmax is defined as the time to reach the observed maximum concentration, t1/2 is defined as the time required to reduce the plasma concentration to one half its initial value, and t is defined as the time of the last observed quantifiable concentration on Day 14 of the respective treatment period. Samples were collected at the following times: pre-dose; 10 minutes (min) and 30 min post-dose; and 1, 2, 4, 6, and 8 hours post-dose for participants who were >=20 kilograms and pre-dose; 10 min and 30 min post-dose; and 1, 2, and 4 hours post-dose for participants who were <=20 kilograms on Day 14 of the respective treatment period.
Measured: Day 14 of the respective treatment period (up to Study Day 49)
Blood Glucose and Potassium on Day 14 of the Respective Treatment Period
Blood glucose and potassium values were measured on Day 14 of the respective treatment period. Samples were collected at the following times: pre-dose; 10 minutes (min) and 30 min post-dose; and 1, 2, 4, 6, and 8 hours post-dose for participants who were >=20 kilograms and pre-dose; 10 min and 30 min post-dose; and 1, 2, and 4 hours post-dose for participants who were <=20 kilograms on Day 14 of the respective treatment period. . Weighted means were derived using the linear trapezoidal rule. Actual relative times were used for the calculation except where actual times were missing. If any actual times were missing, planned relative times were used for these observations. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg. Treatment and period were fitted as fixed effects and participant was fitted as a random effect.
Measured: Day 14 of the respective treatment period (up to Study Day 49)
Average Oropharyngeal Cross-sectional Area on Day 1 and Day 14 of the Respective Treatment Period
During the pharyngometry assessment, participants inhaled through a wavetube, which had a mouthpiece with the same dimensions as the mouthpiece on the dry powder inhaler used for the study. This technique was used to measure the size of the throat and mouth (oropharynx) in the form of pharyngograms. Pharyngometry data were recorded for each day (Day 1 and Day 14 of the respective treatment period) using the mean of four measurements (pharyngograms), and the average oropharyngeal cross-sectional area was calculated.
Measured: Day 1 and Day 14 of the respective treatment period (up to Study Day 49)
Distance of Assessment on Day 1 and Day 14 of the Respective Treatment Period
During the pharyngometry assessment, participants inhaled through a wavetube, which had a mouthpiece with the same dimensions as the mouthpiece on the dry powder inhaler used for this study. This technique was used to measure the size of the throat and mouth (oropharynx) in the form of pharyngograms. Distance of assessment is defined as the distance (length measured in centimeters [cm]) estimated to be from the lips to the larynx. Pharyngometry data were recorded for each day (Days 1 and 14 of the respective treatment period) using the mean of four measurements (pharyngograms), and the average oropharyngeal cross-sectional area was calculated.
Measured: Day 1 and Day 14 of the respective treatment period (up to Study Day 49)
Oropharyngeal Volume on Day 1 and Day 14 of the Respective Treatment Period
During the pharyngometry assessment, participants inhaled through a wavetube, which had a mouthpiece with the same dimensions as the mouthpiece on the dry powder inhaler used for this study. This technique was used to measure the size of the throat and mouth (oropharynx) in the form of pharyngograms. Oropharyngeal volume is defined as the volume (centimeters cubed [cm^3]) of the mouth and throat estimated to be from the lips to the larynx. Pharyngometry data were recorded for each day (Days 1 and 14 of the respective treatment period) using the mean of four measurements (pharyngograms), and the average oropharyngeal cross-sectional area was calculated.
Measured: Day 1 and Day 14 of the respective treatment period (up to Study Day 49)
Average Flow Rate and Peak Inspiratory Flow Rate (PIFR) on Day 1 and Day 14 of the Respective Treatment Period
During the inhalation profile assessment, participants inhaled through a mouthpiece from a device with a similar resistance to the dry powder inhaler used for this study. Average flow rate is defined as the average inspiratory flow rate (Liters [L]/min) across the inhalation profile when inhaling across the resistance of the inhaler. PIFR is defined as the Peak Inspiratory Flow Rate (L/min) of the inhalation profile when inhaling across the resistance of the inhaler.The pressure drop during the inhalation was measured, and the inhalation profiles (pressure drop versus time profile) of the participants were obtained. The mean of the two inhalation profile measurements was used for each day (Days 1 and 14 of the respective treatment period), and the average flow rate and PIFR were determined. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg.
Measured: Day 1 and Day 14 of the respective treatment period (up to Study Day 49)
Inhalation Time on Day 1 and Day 14 of the Respective Treatment Period
During the inhalation profile assessment, participants inhaled through a mouthpiece from a device with a similar resistance to the dry powder inhaler used for this study. Inhalation time is defined as the duration of the inhalation(s) when inhaling across the resistance of the inhaler. The pressure drop during the inhalation was measured, and the inhalation profiles (pressure drop versus time profile) of the participants were obtained. The mean of the two inhalation profile measurements was used for each day (Days 1 and 14 of the respective treatment period), and the inhalation time was determined. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg.
Measured: Day 1 and Day 14 of the respective treatment period (up to Study Day 49)
Inhaled Volume on Day 1 and Day 14 of the Respective Treatment Period
During the inhalation profile assessment, participants inhaled through a mouthpiece from a device with a similar resistance to the dry powder inhaler used for this study. Inhaled volume is defined as the volume of air (Liters) inhaled during the inhalation across the resistance of the inhaler.
The pressure drop during the inhalation was measured, and the inhalation profiles (pressure drop versus time profile) of the participants were obtained. The mean of the two inhalation profile measurements was used for each day (Days 1 and 14 of the respective treatment period), and the inhalaled volume was determined. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg.
Measured: Day 1 and Day 14 of the respective treatment period (up to Study Day 49)
Peak Pressure Drop on Day 1 and Day 14 of the Respective Treatment Period
During the inhalation profile assessment, participants inhaled through a mouthpiece from a device with a similar resistance to the dry powder inhaler used for this study. Peak pressure drop is defined as the maximum pressure drop (kilopascal [kPa]) achieved during inhalation across the resistance of the inhaler. The pressure drop during the inhalation was measured, and the inhalation profiles (pressure drop versus time profile) of the participants were obtained. The mean of the two inhalation profile measurements was calculated for each day (Days 1 and 14 of the respective treatment period), and used for subsequent modeling and prediction of dose emission attributes. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg.
Measured: Day 1 and Day 14 of the respective treatment period (up to Study Day 49)
Total Emitted Dose (TED) on Day 1 and Day 14 of the Respective Treatment Period
The total emitted dose (TED) is defined as the mass (micrograms) of the nominal dose that passes beyond the throat. The recorded inhalation profiles of the participants and the mouth-throat (oropharyngeal) models of the sizes that approximated to pharyngometry measurements of the participants were used in conjunction with the electronic Lung (eLung) for in vitro assessment. The eLung is a breathing simulator that replicates the selected inhalation profile with an active inhaler placed at the lips end of the selected ororpharyngeal model. After the dose is emitted from the inhaler, the analysis and assay of throat deposition and material passing beyond the throat was used to derive the nominal, minimum, and maximum predicted total emitted dose.
Measured: Day 1 and Day 14 of the respective treatment period (up to Study Day 49)
Ex-throat Dose (ETD) and ETD <2 Microns on Day 1 and Day 14 of the Respective Treatment Period
The ex-throat dose (ETD) and the "nominal ETD" is the mass (micrograms) of active investigational material that passes beyond the throat, nominal being the mean.The recorded inhalation profiles of the participants and the mouth-throat (oropharyngeal) models of the sizes that approximated to pharyngometry measurements of the participants were used in conjunction with the electronic Lung (eLung) for in vitro assessment. The eLung is a breathing simulator that replicates the selected inhalation profile with an active inhaler placed at the lips end of the selected ororpharyngeal model. After the dose is emitted from the inhaler, the analysis and assay of throat deposition and material passing beyond the throat was used to derive the nominal, minimum, and maximum predicted ETD and ETD <2 microns.
Measured: Day 1 and Day 14 of the respective treatment period (up to Study Day 49)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2010Apr 2011

First posted17 Oct 2011 (estimated)
Study startAug 2010
Primary completionApr 2011
Study completionApr 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for AsthmaStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01453296
Sponsor's protocol ID: 112776
Status last verified: Nov 2016
First submitted: 1 Sep 2011
Last updated: 13 Jan 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 13 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Placebo-controlled, Two-way Crossover 7-day Study to Investigate the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Repeat Dose Inhaled GW642444 25 μg (Micrograms) in Children Aged 5-11 Years With Persistent Asthma.
ClinicalTrials.gov ID: NCT01453296
Acronym / sponsor ID: 112776
Conditions: Asthma
Keywords: Asthma, Tolerability, Safety, Pharmacokinetics, GW642444
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 28 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: Aug 2010
Primary completion: Apr 2011 (actual)
Study completion: Apr 2011 (actual)
First posted: 17 Oct 2011 (estimated)
Results: Posted 19 Aug 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study will investigate the effect of dosing paedeatric asthmatic subjects with GW642444, an orally inhaled long-acting agonist of the β2-adrenoceptor.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
COHORT 1 (RANDOMISATION AB or BA)	Active comparator	Drug: GW642444, Drug: Placebo8-11 years old; Subjects will be assigned to receive GW642444 25μg or matching placebo (in a 1:1 ratio) in an AB or BA (A= GW64244, B= Placebo) sequence. Following randomisation (AB or BA) subjects will receive a single dose treatment, followed by 7 day washout period. This will then be followed by a repeat dose session of the same treatment (Day 8 and Day 14 in house, Days 9-13 at home). Each subject will then complete the same sequence for the alternative treatment in the second session. There will be a washout period of at least 7 days between the treatment periods.
COHORT 2 (RANDOMISATION AB or BA)	Active comparator	Drug: GW642444, Drug: Placebo5-7 years old. Subjects will be assigned to receive GW642444 25μg or matching placebo (in a 1:1 ratio) in an AB or BA (A= GW64244, B= Placebo) sequence. Following randomisation (AB or BA) subjects will receive a single dose treatment, followed by 7 day washout period. This will then be followed by a repeat dose session of the same treatment (Day 8 and Day 14 in house, Days 9-13 at home). Each subject will then complete the same sequence for the alternative treatment in the second session. There will be a washout period of at least 7 days between the treatment periods.

Who may qualify

Ages: 5 to 11 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (9 listed)

Male and pre-menarchial female subjects aged 5-11 years on the last planned treatment day are eligible for this study. Pre-menarchial females are defined as any female who has yet to begin menses and is considered Tanner Stage 2 or less.
Diagnosis of asthma at least 6 months prior to screening.
Patients must be controlled on their existing asthma treatment at Screening as defined by a Childhood Asthma Control Test score of >19 and PEF (Peak Expiratory Flow) >75 % predicted.
Subjects must be taking a stable regimen of fluticasone propionate (≤200 μg (micrograms) twice daily or equivalent) and short acting beta-agonist inhaler on an as-need basis for at least 4 weeks prior to screening.
Apart from asthma, eczema and rhinitis, subjects should be healthy and suffer from no other significant medical conditions.

Key exclusion criteria (13 listed)

Subjects currently receiving (or have received within 4 weeks of screening) any of the following asthma therapies: theophyllines, long-acting inhaled beta-agonists, oral beta-agonist.
Subjects who have changed their asthma medication within 4 weeks of screening.
Clinical visual evidence of oral candidiasis at screening.
Any clinically relevant abnormality identified on the screening medical assessment
Any medical condition or circumstance making the subject unsuitable for participation in the study (e.g. history of life-threatening asthma)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
GW642444GW642444 25 μg; Novel dry powder inhaler	Drug	COHORT 1 (RANDOMISATION AB or BA), COHORT 2 (RANDOMISATION AB or BA)
PlaceboMatching placebo; Novel dry powder inhaler	Drug	COHORT 1 (RANDOMISATION AB or BA), COHORT 2 (RANDOMISATION AB or BA)

Primary outcome

Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) During the Treatment Period
Time frame: From the start of study medication until Week 11 (Visit 8)/Early Withdrawal
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Medical or scientific judgment should be exercised in deciding whether reporting is appropriate in other situations. Refer to the General AE/SAE module for a complete list of AEs and SAEs.
Basophil, Eosinophil, Lymphocyte, Monocyte, Total Neutrophil, Platelet, and White Blood Cell Count Values at Day 14 of the Respective Treatment Period
Time frame: Day 14 of the respective treatment period (up to Study Day 49)
Blood samples were collected for the measurement of basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelets, and white blood cell (WBC) count at Day 14 of the respective treatment period. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg.
Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Values at Day 14 of the Respective Treatment Period
Time frame: Day 14 of the respective treatment period (up to Study Day 49)
Blood samples were collected for the measurement of hemoglobin and MCHC at Day 14 of the respective treatment period. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg.
Reticulocyte and Red Blood Cell (RBC) Values at Day 14 of the Respective Treatment Period
Time frame: Day 14 of the respective treatment period (up to Study Day 49)
Blood samples were collected for the measurement of reticulocytes and RBCs at Day 14 of the respective treatment period. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg.
Hematocrit Value at Day 14 of the Respective Treatment Period
Time frame: Day 14 of the respective treatment period (up to Study Day 49)
Blood samples were collected for the measurement of hematocrit at Day 14 of the respective treatment period. Hematocrit is a measure of the percentage of the volume of the whole blood that is composed of red blood cells, as determined by separation of red blood cells from the plasma (usually by centrifugation). Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg.
Mean Corpuscle Volume (MCV) Value at Day 14 of the Respective Treatment Period
Time frame: Day 14 of the respective treatment period (up to Study Day 49)
Blood samples were collected for the measurement of MCV at Day 14 of the respective treatment period. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg.
Mean Corpuscle Hemoglobin (MCH) Value at Day 14 of the Respective Treatment Period
Time frame: Day 14 of the respective treatment period (up to Study Day 49)
Blood samples were collected for the measurement of MCH at Day 14 of the respective treatment period. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg.
Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), and Gamma Glutamyl Transferase (GGT) Values at Day 14 of the Respective Treatment Period
Time frame: Day 14 of the respective treatment period (up to Study Day 49)
Blood samples were collected for the measurement of ALT, ALP, AST, and GGT at Day 14 of the respective treatment period. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg.
Albumin and Total Protein Values at Day 14 of the Respective Treatment Period
Time frame: Day 14 of the respective treatment period (up to Study Day 49)
Blood samples were collected for the measurement of albumin and total protein at Day 14 of the respective treatment period. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg.
Calcium, Chloride, Carbon Dioxide (CO2) Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) Values at Day 14 of the Respective Treatment Period
Time frame: Day 14 of the respective treatment period (up to Study Day 49)
Blood samples were collected for the measurement of calcium, chloride, carbon dioxide content/bicarbonate (CO2/BI), glucose, potassium, sodium, and urea/BUN at Day 14 of the respective treatment period. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg.
Total Bilirubin, Direct Bilirubin, Creatinine, and Uric Acid Values at Day 14 of the Respective Treatment Period
Time frame: Day 14 of the respective treatment period (up to Study Day 49)
Blood samples were collected for the measurement of total bilirubin, direct bilirubin, creatinine, and uric acid at Day 14 of the respective treatment period. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg.
Peak Expiratory Flow on Day 1, Day 8, and Day 14 of the Respective Treatment Period
Time frame: Day 1, Day 8, and Day 14 of the respective treatment period (up to Study Day 49)
Peak Expiratory Flow (PEF) is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF is calculated as the maximum of three readings taken at each timepoint for each participant. Baseline is defined as the pre-dose measurement at Day 1 for the respective period. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg (n=28).
Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Day 1, Day 8, and Day 14 of the Respective Treatment Period
Time frame: Day 1, Day 8, and Day 14 of the respective treatment period (up to Study Day 49)
SBP and DBP were measured at Day 1, Day 8, and Day 14 of the respective treatment period. PD=post-dose. Baseline is defined as the pre-dose measurement at Day 1 for the respective period. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg (n=28).
Maximum Heart Rate at Day 1 and Day 14 of the Respective Treatment Period
Time frame: Day 1 and Day 14 of the respective treatment period (up to Study Day 49)
Heart rate (HR) was measured at Day 1 and Day 14 of the respective treatment period. hr=hour. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg (n=28).
Weighted Mean Heart Rate at Day 1 and Day 14 of the Respective Treatment Period
Time frame: Day 1 and Day 14 of the respective treatment period (up to Study Day 49)
Heart rate (HR) was measured at Day 1 and Day 14 of the respective treatment period. hr=hour. Weighted means were derived using the linear trapezoidal rule. Actual relative times were used for the calculation except where actual times were missing. If any actual times were missing, planned relative times were used for these observations. For 0-8 hr parameters, treatment, period, participant Baseline, and period Baseline were fitted as fixed effects, and participant was fitted as a random effect. For 0-2 hr parameters, treatment, period, day (1 and 14), participant Baseline, period Baseline, and treatment*day interaction were fitted as fixed effects, and participant was fitted as a random effect. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg (n=28).
Maximum QTcF at Day 1 and Day 14 of the Respective Treatment Period
Time frame: Day 1 and Day 14 of the respective treatment period (up to Study Day 49)
The electrocardiographic (ECG) parameter QT duration corrected using Fridericia's formula (QTcF) was measured at Day 1 and Day 14 of the respective treatment period. hr=hour. For 0-8 hr parameters, treatment, period, participant Baseline, and period Baseline were fitted as fixed effects, and participant was fitted as a random effect. For 0-2 hr parameters, treatment, period, day (1 and 14), participant Baseline, period Baseline, and treatment*day interaction were fitted as fixed effects, and participant was fitted as a random effect. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg (n=28).
Weighted Mean QTcF at Day 1 and Day 14 of the Respective Treatment Period
Time frame: Day 1 and Day 14 of the respective treatment period (up to Study Day 49)
The electrocardiographic (ECG) parameter QT duration corrected using Fridericia's formula (QTcF) was measured at Day 1 and Day 14 of the respective treatment period. hr=hour. Actual relative times were used for the calculation except where actual times were missing. If any actual times were missing, planned relative times were used for these observations. For 0-8 hr parameters, treatment, period, participant Baseline, and period Baseline were fitted as fixed effects, and participant was fitted as a random effect. For 0-2 hr parameters, treatment, period, day (1 and 14), participant Baseline, period Baseline, and treatment*day interaction were fitted as fixed effects, and participant was fitted as a random effect. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg (n=28).

13 secondary outcomes

AUC(0-t) and AUC(0-8) on Day 14 of the Respective Treatment Period
Time frame: Day 14 of the respective treatment period (up to Study Day 49)
Cmax on Day 14 of the Respective Treatment Period
Time frame: Day 14 of the respective treatment period (up to Study Day 49)
Tmax, t1/2, and t at Day 14 of the Respective Treatment Period
Time frame: Day 14 of the respective treatment period (up to Study Day 49)
Blood Glucose and Potassium on Day 14 of the Respective Treatment Period
Time frame: Day 14 of the respective treatment period (up to Study Day 49)
Average Oropharyngeal Cross-sectional Area on Day 1 and Day 14 of the Respective Treatment Period
Time frame: Day 1 and Day 14 of the respective treatment period (up to Study Day 49)
Distance of Assessment on Day 1 and Day 14 of the Respective Treatment Period
Time frame: Day 1 and Day 14 of the respective treatment period (up to Study Day 49)
Oropharyngeal Volume on Day 1 and Day 14 of the Respective Treatment Period
Time frame: Day 1 and Day 14 of the respective treatment period (up to Study Day 49)
Average Flow Rate and Peak Inspiratory Flow Rate (PIFR) on Day 1 and Day 14 of the Respective Treatment Period
Time frame: Day 1 and Day 14 of the respective treatment period (up to Study Day 49)
Inhalation Time on Day 1 and Day 14 of the Respective Treatment Period
Time frame: Day 1 and Day 14 of the respective treatment period (up to Study Day 49)
Inhaled Volume on Day 1 and Day 14 of the Respective Treatment Period
Time frame: Day 1 and Day 14 of the respective treatment period (up to Study Day 49)
Peak Pressure Drop on Day 1 and Day 14 of the Respective Treatment Period
Time frame: Day 1 and Day 14 of the respective treatment period (up to Study Day 49)
Total Emitted Dose (TED) on Day 1 and Day 14 of the Respective Treatment Period
Time frame: Day 1 and Day 14 of the respective treatment period (up to Study Day 49)
Ex-throat Dose (ETD) and ETD <2 Microns on Day 1 and Day 14 of the Respective Treatment Period
Time frame: Day 1 and Day 14 of the respective treatment period (up to Study Day 49)

Results and safety

Results posted to the registry on 19 Aug 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sequence 1: VI 25 µg Followed by Placebo	14	13
Sequence 2: Placebo Followed by VI 25 µg	14	13

Primary outcome: Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) During the Treatment Period

Time frame: From the start of study medication until Week 11 (Visit 8)/Early Withdrawal. Number. Unit: Participants

Measure	Placebo n = 26	VI 25 µg n = 27
Any AE	6	9
Any SAE	0	0

Population analysed: All Subjects Population: all participants who received at least one dose of study medication

Primary outcome: Basophil, Eosinophil, Lymphocyte, Monocyte, Total Neutrophil, Platelet, and White Blood Cell Count Values at Day 14 of the Respective Treatment Period

Time frame: Day 14 of the respective treatment period (up to Study Day 49). Mean (Standard Deviation). Unit: 10^9 cells per liter (GI/L)

Measure	Placebo n = 26	VI 25 µg n = 27
Basophils, n=24, 25	0.021 (0.0145)	0.034 (0.0185)
Eosinophils, n=24, 25	0.276 (0.3002)	0.348 (0.3458)
Lymphocytes, n=24, 25	2.404 (0.8652)	2.419 (0.8729)
Monocytes, n=24, 25	0.268 (0.1310)	0.376 (0.1419)
Total neutrophils, n=24, 25	3.354 (1.3054)	3.127 (0.9625)
Platelets, n=23, 25	280.7 (54.11)	279.4 (54.71)
WBCs, n=24, 25	6.32 (1.808)	6.30 (1.640)

Population analysed: All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.

Primary outcome: Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Values at Day 14 of the Respective Treatment Period

Time frame: Day 14 of the respective treatment period (up to Study Day 49). Mean (Standard Deviation). Unit: Grams per liter (g/L)

Measure	Placebo n = 26	VI 25 µg n = 27
Hemoglobin, n=24, 25	133.0 (11.30)	130.7 (11.22)
MCHC, n=24, 25	337.1 (5.50)	338.3 (11.60)

Primary outcome: Reticulocyte and Red Blood Cell (RBC) Values at Day 14 of the Respective Treatment Period

Time frame: Day 14 of the respective treatment period (up to Study Day 49). Mean (Standard Deviation). Unit: 10^12 cells per liter (TI/L)

Measure	Placebo n = 26	VI 25 µg n = 27
Reticulocytes, n=24, 25	0.05010 (0.020696)	0.05275 (0.024571)
RBCs, n=24, 25	4.60 (0.374)	4.47 (0.339)

13 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 26 (0%)	6 of 26 (23.1%)	Not reported
VI 25 µg	0 of 27 (0%)	9 of 27 (33.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GW642444 in people with Asthma, run by GlaxoSmithKline at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Aug 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) During the Treatment Period (time frame: From the start of study medication until Week 11 (Visit 8)/Early Withdrawal). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01453296.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2017.