AsthmaPhase 2NCT01287065
A Study in Asthmatic Patients to Determine if There is Any Difference in Dosing With Fluticasone Furoate/Vilanterol Inhalation Powder in the Morning or Evening on Lung Function
A Phase 2 study testing FF(100mcg)/Vilanterol(25mcg) AM and FF(100mcg)/Vilanterol(25mcg) PM in people with Asthma, run by GlaxoSmithKline at 1 site in New Zealand.
Trial summary
This study will be a repeat-dose, double-blind, randomized, placebo controlled, three-way crossover study in patients with persistent bronchial asthma to compare the effect of morning (AM) and evening (PM) dosing with fluticasone furoate (FF)/Vilanterol (VI) inhalation powder on lung function. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Asthma
- What is being tested?
- FF(100mcg)/Vilanterol(25mcg) AM and FF(100mcg)/Vilanterol(25mcg) PM
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteNew Zealand
- Study dates
- Oct 2010to Sep 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with a documented history of persistent asthma, with the exclusion of other significant pulmonary diseases.
- Male or female between 18 and 70 years of age inclusive
- A female subject is eligible to participate if she is of:
- Non-childbearing potential. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of postmenopausal status prior to study enrollment.
- Child-bearing potential and agrees to use one of the protocol contraception methods.
- All subjects must be using an inhaled corticosteroid (ICS), with or without a short-acting, beta2-receptor agonist (SABA), for at least 12 weeks prior to screening.
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- Subjects with a screening pre-bronchodilator FEV1 ≥ 60% of predicted.
- During the screening visit, subjects must demonstrate the presence of reversible airway disease.
- All subjects must be able to replace all their current asthma treatments with albuterol/salbutamol aerosol inhaler at screening for use as needed for the run-in period and throughout the duration of the study. Subjects must be able to withhold albuterol/salbutamol for at least 6 hours prior to study visits.
- Subjects who are current non-smokers, who have not used any inhaled tobacco products in the 12 month period preceding the screening visit.
- Body weight ≥ 50 kg and Body Mass Index (BMI) within the range 19.0-29.9 kg/m2 (inclusive).
- No evidence of significant abnormality in the 12-lead ECG performed at screening.
- Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) < 2x Upper limit of normal (ULN); alkaline phosphatase and bilirubin ≤ 1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
- Capable of giving written informed consent
- Able to satisfactorily use the novel dry powder inhaler.
Who cannot join
- A history of life-threatening asthma within the last 5 years.
- Culture-documented or suspected bacterial or viral infection that is not resolved within 4 weeks of screening and led to a change in asthma management or, in the opinion of the Investigator, is expected to affect the subject's asthma status or the subject's ability to participate in the study.
- Any asthma exacerbation requiring oral corticosteroids within 12 weeks of screening or that resulted in overnight hospitalization requiring additional treatment for asthma within 6 months prior to screening.
- A subject has any clinically significant, uncontrolled condition or disease state that, in the opinion of the investigator, would put the safety of the subject at risk through study participation.
- A subject will not be eligible if he/she has clinical visual evidence of oral candidiasis at screening.
- Pregnant females.
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- Lactating females.
- The subject has participated in a clinical trial and has received an investigational product within 30 days prior to the first dosing day in the current study.
- Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
- Any adverse reaction including immediate or delayed hypersensitivity to any beta 2- agonist, sympathomimetic drug, or any intranasal, inhaled, or systemic corticosteroid therapy.
- History of severe milk protein allergy.
- History of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
- Use of prescription or non-prescription drugs within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
- Subjects who have taken high doses of an ICS within 8 weeks of the screening visit or oral steroids within 12 weeks of the screening visit.
- Subjects who have changed their ICS treatment within the last 4 weeks before screening or can be expected to do so during the study.
- History of regular alcohol consumption within 6 months of the study.
- A positive test for Hepatitis B or Hepatitis C within 3 months of screening.
- A positive breath carbon monoxide (CO) test.
- A positive pre-study drug/alcohol screen.
- A positive test for Human Immunodeficiency Virus (HIV) antibody.
- Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
- No subject is permitted to perform night shift work for 1 week prior to screening until completion of the study treatment periods.
- Unwillingness or inability to follow the procedures outlined in the protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Repeat-dose, Placebo-controlled, Double-blind Study to Evaluate and Compare the Efficacy of Fluticasone Furoate/Vilanterol Inhalation Powder, When Administered Either in the Morning or in the Evening, in Male and Female Asthmatic Subjects
This study will be a repeat-dose, double-blind, randomized, placebo controlled, three-way crossover study in patients with persistent bronchial asthma to compare the effect of morning (AM) and evening (PM) dosing with fluticasone furoate (FF)/Vilanterol (VI) inhalation powder on lung function. Following screening there will be a run-in period of 14 days. There will be 3 treatment periods; drug at AM, drug at PM and placebo, which will last for 14 days each with a 14-21 day washout period between starting the next. Key assessments include; forced expiratory volume in one second (FEV1), peak expiratory flow (PEF), vital signs, electrocardiograms (ECGs), adverse event (AE) monitoring and laboratory safety tests.
Read the detailed description
This will be a repeat-dose, double-blind, randomized, placebo controlled, three-way crossover study in patients with persistent bronchial asthma to compare the effect of AM and PM dosing with fluticasone furoate (FF)/Vilanterol (VI) inhalation powder(100/25mcg) on lung function. Twenty-four male and female patients will be enrolled in this study to ensure twenty evaluable subjects. After the screening there will be a run-in period of 14 days prior to first dose. Subjects will be dosed for 14 days (± 2 days) in each of the 3 treatment periods, with serial forced expiratory volume in one second (FEV1) measurements taken over a 24 hour period following the Day 14 PM dose in order to determine FEV1 weighted mean (0-24 hours). Peak expiratory flow (PEF) will also be monitored throughout the study, from the start of the run-in period until the end of the third treatment period. Between treatment periods there will be a washout period of 14-21 days. Safety assessments will include vital signs, electrocardiograms (ECGs), adverse event (AE) monitoring and laboratory safety tests, however, with the exception of AEs these will not constitute study endpoints. The results of the study will provide supporting information to understand the implications of time of day of dosing on the therapeutic response to the FF/VI Inhalation Powder.
- Conditions
- Asthma
- Being tested
- FF(100mcg)/Vilanterol(25mcg) AM, FF(100mcg)/Vilanterol(25mcg) PM, Placebo AM, Placebo PM
- Keywords
- Fluticasone furoate, Vilanterol, Efficacy, FEV1, FF/VI Inhalation powder
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FF(100mcg)/Vilanterol(25mcg) AMDrug
Inhalation powder
FF(100mcg)/Vilanterol(25mcg) PMDrug
Inhalation powder
Placebo AMDrug
Inhalation powder
Placebo PMDrug
Inhalation powder
| Study group | Role | What they receive |
|---|---|---|
| FF(100mcg)/Vilanterol(25mcg) - AM dosing | Experimental | FF(100mcg)/Vilanterol(25mcg) in the morning (approx 09.00) for 14 days (± 2 days).; placebo in evening (approx 21.00) for 14 days (± 2 days). Receives: Drug: FF(100mcg)/Vilanterol(25mcg) AM; Drug: Placebo PM |
| FF(100mcg)/Vilanterol(25mcg) - PM dosing | Experimental | Placebo in morning (approx 09.00) for 14 days (± 2 days); FF(100mcg)/Vilanterol(25mcg) in evening (approx 21.00) for 14 days (± 2 days). Receives: Drug: FF(100mcg)/Vilanterol(25mcg) PM; Drug: Placebo AM |
| Placebo | Placebo comparator | Placebo given in morning (approx 09.00) and in evening (approx (21.00) for 14 days (± 2 days). Receives: Drug: Placebo AM; Drug: Placebo PM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weighted Mean Forced Expiratory Volume in One Second (FEV1) Over 0-24 Hours Post-dose on Day 14
Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured electronically by spirometry at Day 14. Weighted mean FEV1 was calculated using the Day 14 24-hour serial FEV1 measurements taken at the following time points: pre-dose (Day 14 evening dose), and 3, 6, 9, 12, 15, 18, 21 and 24 hours post-dose (measured in the evening of Day 15). At each time point, the highest of 3 technically acceptable measurements was recorded. The analysis was performed using a mixed effects analysis of covariance model with fixed effect terms for treatment and period; and participant (par.) baseline, period baseline, gender and age fitted as covariates; and par. as a random effect. Par. 122 received FF/VI 100/25 PM in treatment periods 1 and 3 and contributed twice to the summary of FF/VI 100/25 PM (n=25). Par. 123 received Placebo in treatment periods 2 and 3 and contributed twice to the summary of Placebo (n=20).
Measured: Pre-dose on Day 14 to 24 hours post-dose
Secondary outcomes (3)
Pre-treatment PEF (AM and PM) on Days 1-12.
PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants daily in the morning and evening just prior to each dose, using an electronic peak flow meter, throughout the 14-day Treatment Period. Only the averaged daily AM and PM PEF over Days 2 to 12 was analyzed. The analysis was performed using a mixed effect analysis of covariance model with fixed effect terms for treatment and period; baseline PEF AM and PM, gender and age fitted as covariates; and participant as a random effect. Participant 122 received FF/VI 100/25 PM in treatment periods 1 and 3 and contributed twice to the summary of FF/VI 100/25 PM (n=26). Participant 123 received Placebo in treatment periods 2 and 3 and contributed twice to the summary of Placebo (n=24).
Measured: From Day 2 up to Day 12
AM and PM Pre-treatment Trough FEV1 on Day 14
Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured electronically by spirometry at Day 14. Trough FEV1 is defined as pre-dose (AM and PM) FEV1 measurement taken on Day 14. The analysis was performed using a mixed effects analysis of covariance model with fixed effect terms for treatment and period; and participant baseline, period baseline, gender and age fitted as covariates; and participant as a random effect. Participant 122 received FF/VI 100/25 PM in treatment periods 1 and 3 and contributed twice to the summary of FF/VI 100/25 PM (n=25). Participant 123 received Placebo in treatment periods 2 and 3 and contributed twice to the summary of Placebo (n=23).
Measured: Day 14
Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE)
An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An 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, associated with liver injury and impaired liver function defined as alanine aminotransferase >=3 x upper limit of normal (ULN) and total bilirubin >=2 x ULN or international normalised ratio >1.5. Medical or scientific judgment was exercised in deciding whether reporting was appropriate in other situations. Refer to the general AE/SAE module for a list of AEs and SAEs.
Measured: From the first dose of the study medication until the Follow-up Visit (up to 18 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2011 (estimated)
- Study startOct 2010
- Primary completionSep 2011
- Study completionSep 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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01287065
- Sponsor's protocol ID
- 114624
- Status last verified
- Nov 2016
- First submitted
- 27 Jan 2011
- Last updated
- 11 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.
Publications
Kempsford RD, Oliver A, Bal J, Tombs L, Quinn D. The efficacy of once-daily fluticasone furoate/vilanterol in asthma is comparable with morning or evening dosing. Respir Med. 2013 Dec;107(12):1873-80. doi: 10.1016/j.rmed.2013.07.002. Epub 2013 Nov 5.
PubMed 24200619
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Repeat-dose, Placebo-controlled, Double-blind Study to Evaluate and Compare the Efficacy of Fluticasone Furoate/Vilanterol Inhalation Powder, When Administered Either in the Morning or in the Evening, in Male and Female Asthmatic Subjects
- ClinicalTrials.gov ID
- NCT01287065
- Acronym / sponsor ID
- 114624
- Conditions
- Asthma
- Keywords
- Fluticasone furoate, Vilanterol, Efficacy, FEV1, FF/VI Inhalation powder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 1 Feb 2011 (estimated)
- Results
- Posted 9 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 be a repeat-dose, double-blind, randomized, placebo controlled, three-way crossover study in patients with persistent bronchial asthma to compare the effect of morning (AM) and evening (PM) dosing with fluticasone furoate (FF)/Vilanterol (VI) inhalation powder on lung function. Following screening there will be a run-in period of 14 days. There will be 3 treatment periods; drug at AM, drug at PM and placebo, which will last for 14 days each with a 14-21 day washout period between starting the next. Key assessments include; forced expiratory volume in one second (FEV1), peak expiratory flow (PEF), vital signs, electrocardiograms (ECGs), adverse event (AE) monitoring and laboratory safety tests.
Detailed description
This will be a repeat-dose, double-blind, randomized, placebo controlled, three-way crossover study in patients with persistent bronchial asthma to compare the effect of AM and PM dosing with fluticasone furoate (FF)/Vilanterol (VI) inhalation powder(100/25mcg) on lung function. Twenty-four male and female patients will be enrolled in this study to ensure twenty evaluable subjects. After the screening there will be a run-in period of 14 days prior to first dose. Subjects will be dosed for 14 days (± 2 days) in each of the 3 treatment periods, with serial forced expiratory volume in one second (FEV1) measurements taken over a 24 hour period following the Day 14 PM dose in order to determine FEV1 weighted mean (0-24 hours). Peak expiratory flow (PEF) will also be monitored throughout the study, from the start of the run-in period until the end of the third treatment period. Between treatment periods there will be a washout period of 14-21 days. Safety assessments will include vital signs, electrocardiograms (ECGs), adverse event (AE) monitoring and laboratory safety tests, however, with the exception of AEs these will not constitute study endpoints. The results of the study will provide supporting information to understand the implications of time of day of dosing on the therapeutic response to the FF/VI Inhalation Powder.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| FF(100mcg)/Vilanterol(25mcg) - AM dosing | Experimental | Drug: FF(100mcg)/Vilanterol(25mcg) AM, Drug: Placebo PMFF(100mcg)/Vilanterol(25mcg) in the morning (approx 09.00) for 14 days (± 2 days).; placebo in evening (approx 21.00) for 14 days (± 2 days). |
| FF(100mcg)/Vilanterol(25mcg) - PM dosing | Experimental | Drug: FF(100mcg)/Vilanterol(25mcg) PM, Drug: Placebo AMPlacebo in morning (approx 09.00) for 14 days (± 2 days); FF(100mcg)/Vilanterol(25mcg) in evening (approx 21.00) for 14 days (± 2 days). |
| Placebo | Placebo comparator | Drug: Placebo AM, Drug: Placebo PMPlacebo given in morning (approx 09.00) and in evening (approx (21.00) for 14 days (± 2 days). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Subjects with a documented history of persistent asthma, with the exclusion of other significant pulmonary diseases.
- Male or female between 18 and 70 years of age inclusive
- A female subject is eligible to participate if she is of:
- All subjects must be using an inhaled corticosteroid (ICS), with or without a short-acting, beta2-receptor agonist (SABA), for at least 12 weeks prior to screening.
- Subjects with a screening pre-bronchodilator FEV1 ≥ 60% of predicted.
Key exclusion criteria (23 listed)
- A history of life-threatening asthma within the last 5 years.
- Culture-documented or suspected bacterial or viral infection that is not resolved within 4 weeks of screening and led to a change in asthma management or, in the opinion of the Investigator, is expected to affect the subject's asthma status or the subject's ability to participate in the study.
- Any asthma exacerbation requiring oral corticosteroids within 12 weeks of screening or that resulted in overnight hospitalization requiring additional treatment for asthma within 6 months prior to screening.
- A subject has any clinically significant, uncontrolled condition or disease state that, in the opinion of the investigator, would put the safety of the subject at risk through study participation.
- A subject will not be eligible if he/she has clinical visual evidence of oral candidiasis at screening.
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 |
|---|---|---|
| FF(100mcg)/Vilanterol(25mcg) AMInhalation powder | Drug | FF(100mcg)/Vilanterol(25mcg) - AM dosing |
| FF(100mcg)/Vilanterol(25mcg) PMInhalation powder | Drug | FF(100mcg)/Vilanterol(25mcg) - PM dosing |
| Placebo AMInhalation powder | Drug | FF(100mcg)/Vilanterol(25mcg) - PM dosing, Placebo |
| Placebo PMInhalation powder | Drug | FF(100mcg)/Vilanterol(25mcg) - AM dosing, Placebo |
Primary outcome
Weighted Mean Forced Expiratory Volume in One Second (FEV1) Over 0-24 Hours Post-dose on Day 14
Time frame: Pre-dose on Day 14 to 24 hours post-dose
Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured electronically by spirometry at Day 14. Weighted mean FEV1 was calculated using the Day 14 24-hour serial FEV1 measurements taken at the following time points: pre-dose (Day 14 evening dose), and 3, 6, 9, 12, 15, 18, 21 and 24 hours post-dose (measured in the evening of Day 15). At each time point, the highest of 3 technically acceptable measurements was recorded. The analysis was performed using a mixed effects analysis of covariance model with fixed effect terms for treatment and period; and participant (par.) baseline, period baseline, gender and age fitted as covariates; and par. as a random effect. Par. 122 received FF/VI 100/25 PM in treatment periods 1 and 3 and contributed twice to the summary of FF/VI 100/25 PM (n=25). Par. 123 received Placebo in treatment periods 2 and 3 and contributed twice to the summary of Placebo (n=20).
3 secondary outcomes
Pre-treatment PEF (AM and PM) on Days 1-12.
Time frame: From Day 2 up to Day 12
AM and PM Pre-treatment Trough FEV1 on Day 14
Time frame: Day 14
Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE)
Time frame: From the first dose of the study medication until the Follow-up Visit (up to 18 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24200619Kempsford RD, Oliver A, Bal J, Tombs L, Quinn D. The efficacy of once-daily fluticasone furoate/vilanterol in asthma is comparable with morning or evening dosing. Respir Med. 2013 Dec;107(12):1873-80. doi: 10.1016/j.rmed.2013.07.002. Epub 2013 Nov 5.
- 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FF(100mcg)/Vilanterol(25mcg) AM and FF(100mcg)/Vilanterol(25mcg) PM in people with Asthma, run by GlaxoSmithKline at 1 site in New Zealand.
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 15 inclusion and 23 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 11 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 1 site in New Zealand. 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. Some participants in this study may receive a placebo. 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 9 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?
Weighted Mean Forced Expiratory Volume in One Second (FEV1) Over 0-24 Hours Post-dose on Day 14 (time frame: Pre-dose on Day 14 to 24 hours post-dose). 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 NCT01287065, which also lists 1 linked publication.
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 11 Jan 2017.