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AsthmaPhase 1NCT01984086

Study to Evaluate the Pharmacokinetic Profile of Salbutamol Delivered by Unit Dose Dry Powder Inhaler (UD-DPI) Compared to the Diskus and Metered Dose Inhaler (MDI) in Healthy Volunteers.

A Phase 1 study testing Salbutamol Sulphate 150mcg UD-DPI Blister(1.6% blend), Salbutamol Sulphate 200mcg UD-DPI Blister(1.6% blend) and Salbutamol Sulphate 250mcg UD-DPI Blister(1.6% blend) in people with Asthma, run by GlaxoSmithKline at 1 site in Australia.

Completed

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

Official record
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Trial summary

This is an open-label, two part, six period- cross over, randomised, single dose, single centre study in healthy subjects. This is the first clinical study for the UD-DPI. This study is divided into two parts. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Asthma
What is being tested?
Salbutamol Sulphate 150mcg UD-DPI Blister(1.6% blend), Salbutamol Sulphate 200mcg UD-DPI Blister(1.6% blend) and Salbutamol Sulphate 250mcg UD-DPI Blister(1.6% blend)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteAustralia
Study dates
21 Oct 2013to 26 May 2014
Phase
Phase 1
Are there results?
None posted in the registry

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 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Male/females aged between 18 and 65 years of age inclusive, at the time of signing the informed consent.
  • Body weight >=50 kg and body mass index within the range 19.0 - 34.0 kilogram per square meter (inclusive).
  • A female subject is eligible to participate if she is of: Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy for this definition, "documented" refers to the outcome of the investigator's/designee's review of the subject's medical history for study eligibility, as obtained via a verbal interview with the subject or from the subject's medical records; or postmenopausal defined as 12 months of spontaneous amenorrhea in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) >40 milli-international units per milliliter (MlU/mL) and estradiol < 40 picograms per milliliter (pg/mL) (<147 picomole per liter) is confirmatory. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods in listed in protocol if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment. For most forms of HRT, at least 2-4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method; Child-bearing potential with negative pregnancy test as determined by serum human chorionic gonadotropin (hCG) test at screening or urine hCG prior to dosing AND; Agrees to use one of the contraception methods listed in protocol for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception until follow-up; OR has only same-sex partners, when this is her preferred and usual lifestyle.
  • Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form
  • Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or exclusion criteria, outside the reference range for the population being studied may be included only if the Investigator agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
  • Alanine transaminase, alkaline phosphatase and bilirubin >1.5x upper limit of normal (ULN) (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
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  • Based on single or averaged corrected QT interval (QTc) values of triplicate ECGs obtained over a brief recording period: QTcF <450 milliseconds.
  • Current non-smokers who have not used any tobacco- containing products within 3 months of screening and with a total pack year history of <=10 pack years [number of pack years = (number of cigarettes per day / 20) x number of years smoked].
  • Able to use all medical device products included in the study adequately after training
  • Part B
  • Able to tolerate the charcoal block at screening

Who cannot join

  • Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
  • History of sensitivity to any of the study medications, or components thereof (including milk protein allergy) or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
  • A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
  • A positive pre-study breath carbon monoxide test or urine drug or breath alcohol screen.
  • A positive test for HIV antibody.
  • Screening PR interval outside the range 120 to 240msec; or an ECG that is not suitable for QT measurements (eg poorly defined termination of T-wave)
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  • Pregnant or lactating females or females actively trying to conceive.
  • Where participation in the study would result in donation of blood or blood products in excess of 500 millilitres within a 56 day period.
  • The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
  • Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
  • An unwillingness to abstain from strenuous exercise starting 72 hours prior to each dosing day
  • An unwillingness to abstain from caffeine- and xantheine- containing products for 24 hours prior to dosing.
  • Subject is mentally or legally incapacitated
  • Part B
  • Previous participation in Part A of this study (200921)

Trial locations and contacts

1 site in 1 country.

Australia1 site

  • GSK Investigational Site

    Randwick, New South Wales, 2031

Other trials in Australia

About this study

Official title: An Open-label, Randomised, Cross-over, Two Cohort, Single Dose Study in Healthy Volunteers to Evaluate the Unit Dose Dry Powder Inhaler (UD-DPI) for the Delivery of Salbutamol and to Compare the Pharmacokinetic Profile With the MDI and Diskus Presentations.

This is an open-label, two part, six period- cross over, randomised, single dose, single centre study in healthy subjects. This is the first clinical study for the UD-DPI. This study is divided into two parts. Part A will ascertain whether the pharmacokinetic (PK) of salbutamol delivered via the UD-DPI is comparable to the salbutamol delivered via the Diskus or MDI. For this reason four treatment doses consisting of three dose strength and two percentage blends will be assessed in Part A delivered via UD-DPI. Part A will also provide preliminary PK variability estimates to allow for better sample size/precision calculations for Part B. Part B will explore whether the UD-DPI has a pharmacokinetic exposure profile that is comparable to either Diskus or MDI in the presence of the charcoal block.

Conditions
Asthma
Being tested
Salbutamol Sulphate 150mcg UD-DPI Blister(1.6% blend), Salbutamol Sulphate 200mcg UD-DPI Blister(1.6% blend), Salbutamol Sulphate 250mcg UD-DPI Blister(1.6% blend), Salbutamol Sulphate 200mcg UD-DPI Blister(1% blend), Salbutamol Diskus 200mcg Blister
Keywords
COPD, Asthma, Respiratory
Medical subject headings
Asthma, Pulmonary Disease, Chronic Obstructive

What participants receive

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

  • Salbutamol Sulphate 150mcg UD-DPI Blister(1.6% blend)Drug

    Salbutamol Sulphate 150mcg UD-DPI will be supplied as blister containing a small quantity of powder comprising of a blend of salbutamol sulphate (micronized) and excipients

  • Salbutamol Sulphate 200mcg UD-DPI Blister(1.6% blend)Drug

    Salbutamol Sulphate 200mcg UD-DPI will be supplied as blister containing a small quantity of powder comprising of a blend of salbutamol sulphate (micronized) and excipients

  • Salbutamol Sulphate 250mcg UD-DPI Blister(1.6% blend)Drug

    Salbutamol Sulphate 250mcg UD-DPI will be supplied as blister containing a small quantity of powder comprising of a blend of salbutamol sulphate (micronized) and excipients

  • Salbutamol Sulphate 200mcg UD-DPI Blister(1% blend)Drug

    Salbutamol Sulphate 200mcg UD-DPI will be supplied as blister containing a small quantity of powder comprising of a blend of salbutamol sulphate (micronized) and excipients

  • Salbutamol Diskus 200mcg BlisterDrug

    Salbutamol Diskus 200mcg will be supplied as blister strip contained within the Diskus device. Each blister contains a small quantity of powder comprising of a blend of salbutamol sulphate (micronized) and excipients

  • Salbutamol MDI 100mcgDrug

    Salbutamol MDI 100mcg will be supplied as formulation of salbutamol sulphate (micronized) in propellant contained within the pressurised MDI device

  • Salbutamol Sulphate UD-DPI Blister (selected from Part A)Drug

    Formulation will be determined depending on the outcome of Part A.

  • Salbutamol Sulphate 250mcg UD-DPI Blister (selected from Part A)Drug

    Formulation will be determined depending on the outcome of Part A.

  • Salbutamol Diskus 200mcg Blister without activated charcoalDrug

    Formulation will be determined depending on the outcome of Part A.

  • Salbutamol Diskus 200mcg Blister with activated charcoalDrug

    Formulation will be determined depending on the outcome of Part A.

  • Salbutamol MDI 100mcg without activated charcoalDrug

    Formulation will be determined depending on the outcome of Part A.

  • Salbutamol MDI 100mcg with activated charcoalDrug

    Formulation will be determined depending on the outcome of Part A.

Study groups in NCT01984086
Study groupRoleWhat they receive
Part AExperimentalSubjects will receive following six treatments each in six period, with a 3-days minimum wash-out period, between each treatment period: 1) Single dose (SD) salbutamol (200mcg per blister from 1.6% blend) delivered via the UD-DPI by inhalation of 3 Blisters (BTR) giving a total dose of 600mcg; 2) SD salbutamol sulphate (200mcg per BTR from a 1.0% blend) delivered via the UD-DPI by inhalation of 3 BTR giving a total dose of 600mcg; 3) SD salbutamol (150mcg per BTR from a 1.6% blend) delivered via the UD-DPI by inhalation of 3 BTR giving a total dose of 450mcg; 4) SD salbutamol (250mcg per BTR from a 1.6% blend) delivered via the UD-DPI by inhalation of 3 BTR giving a total dose of 750mcg; 5) SD of salbutamol (200mcg per BTR) delivered via the Diskus by inhalation of 3 BTR giving a total dose of 600mcg; 6) SD salbutamol (100mcg per actuation) delivered via the MDI giving a total dose of 600mcg
Receives: Drug: Salbutamol Sulphate 150mcg UD-DPI Blister(1.6% blend); Drug: Salbutamol Sulphate 200mcg UD-DPI Blister(1.6% blend); Drug: Salbutamol Sulphate 250mcg UD-DPI Blister(1.6% blend); Drug: Salbutamol Sulphate 200mcg UD-DPI Blister(1% blend); Drug: Salbutamol Diskus 200mcg Blister; Drug: Salbutamol MDI 100mcg
Part BExperimentalPrior to the start of Part B, a decision will be made regarding the UD-DPI products to be used in Part B. Subjects will receive following 6 treatments each in 6 period, with a 3-days minimum wash-out period, between each treatment period: 1) SD salbutamol (selected from Part A) delivered via the UD-DPI without activated charcoal (AC) by inhalation of 3 BTR (total dose dependant on UD-DPI formulation chosen); 2) SD salbutamol (selected from Part A) delivered via the UD-DPI with AC by inhalation of 3 BTR (total dose dependant on UD-DPI formulation chosen); 3) SD salbutamol by inhalation of 3 BTR (200mcg per BTR) delivered via the Diskus without AC (total dose 600mcg); 4) SD salbutamol by inhalation of 3 BTR (200mcg per BTR) delivered via the Diskus with AC (total dose 600mcg); 5) SD salbutamol 6 inhalations (100mcg) delivered via the MDI without AC (total dose 600mcg); 6) SD salbutamol 6 inhalations (100mcg) delivered via the MDI with AC (total dose 600mcg)
Receives: Drug: Salbutamol Sulphate UD-DPI Blister (selected from Part A); Drug: Salbutamol Sulphate 250mcg UD-DPI Blister (selected from Part A); Drug: Salbutamol Diskus 200mcg Blister without activated charcoal; Drug: Salbutamol Diskus 200mcg Blister with activated charcoal; Drug: Salbutamol MDI 100mcg without activated charcoal; Drug: Salbutamol MDI 100mcg with activated charcoal

What is being measured

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

  1. Part A: Pharmacokinetics parameters of single doses of salbutamol in healthy subjects delivered via the UD-DPI device, using a range of doses and blends, and to compare to MDI and Diskus

    PK parameters include: area under the concentration-time curve from time zero (pre-dose) to 12 hours (hr) (AUC [0-12hr]) and/ or area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUC [0-infinity]) and/ or area under the concentration-time curve from time zero (pre-dose) to last time of quantifiable concentration (AUC [0-t]) and maximum observed concentration (Cmax).

    Measured: Day 1 of each treatment period (Pre dose and 0 hr, 2 minute [min], 5 min, 10 min, 20 min, 30 min, 45 min, 1hr, 1.5 hr, 2hr, 4 hr, 6 hr, 8 hr, 10 hr and 12 hr post dose)

  2. Part B: Pharmacokinetics parameters of salbutamol in healthy subjects delivered via UD-DPI versus Diskus and/or MDI with charcoal blockade.

    PK parameters include: AUC(0- infinity) or AUC(0-t) and Cmax

    Measured: Day 1 of each treatment period (Pre dose and 0 hr, 2 minute [min], 5 min, 10 min, 20 min, 30 min, 45 min, 1hr, 1.5 hr, 2hr, 4 hr, 6 hr, 8 hr, 10 hr and 12 hr post dose)

Secondary outcomes (5)

  1. Part A: Pharmacokinetic parameters following single doses of salbutamol and different blends of salbutamol in healthy subjects delivered via UD-DPI

    PK parameters include: area under the concentration-time curve from time zero (pre-dose) to 30 min (AUC [0-30 min]) and time to maximum observed concentration (tmax).

    Measured: Day 1 of each treatment period (Pre dose and 0 hr, 2 minute [min], 5 min, 10 min, 20 min, 30 min, 45 min, 1hr, 1.5 hr, 2hr, 4 hr, 6 hr, 8 hr, 10 hr and 12 hr post dose)

  2. Part B: Pharmacokinetic parameters following single doses of salbutamol in healthy subjects delivered via UD-DPI , MDI and Diskus with/ and without charcoal

    PK parameters include: AUC [0 30 min] and tmax

    Measured: Day 1 of each treatment period (Pre dose and 0 hr, 2 minute [min], 5 min, 10 min, 20 min, 30 min, 45 min, 1hr, 1.5 hr, 2hr, 4 hr, 6 hr, 8 hr, 10 hr and 12 hr post dose)

  3. Part A and B: Number of subjects with adverse events (AEs)

    Measured: Up to 14 days after the last dose of study treatment.

  4. Part A and B: Safety and tolerability of salbutamol, as assessed vital signs

    Vital sign measurements to be measurement include systolic and diastolic blood pressure and pulse rate

    Measured: Day 1 of each treatment period

  5. Part A and B: Safety and tolerability of salbutamol, as assessed by 12-lead electrocardiogram (ECG) parameters

    Single 12-lead ECGs will be obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and corrected QT interval using Fredericia's formula (QTcF) intervals.

    Measured: Day 1 of each treatment period

Timeline

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

  1. First posted14 Nov 2013 (estimated)
  2. Study start21 Oct 2013
  3. Primary completion26 May 2014
  4. Study completion26 May 2014

Resources

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 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01984086
Sponsor's protocol ID
200921
Status last verified
Jun 2018
First submitted
7 Nov 2013
Last updated
19 Jun 2018
Results posted
No
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.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Salbutamol Sulphate 150mcg UD-DPI Blister(1.6% blend), Salbutamol Sulphate 200mcg UD-DPI Blister(1.6% blend) and Salbutamol Sulphate 250mcg UD-DPI Blister(1.6% blend) in people with Asthma, run by GlaxoSmithKline at 1 site in Australia.

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 11 inclusion and 15 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 19 Jun 2018. 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 Australia. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Part A: Pharmacokinetics parameters of single doses of salbutamol in healthy subjects delivered via the UD-DPI device, using a range of doses and blends, and to compare to MDI and Diskus (time frame: Day 1 of each treatment period (Pre dose and 0 hr, 2 minute [min], 5 min, 10 min, 20 min, 30 min, 45 min, 1hr, 1.5 hr, 2hr, 4 hr, 6 hr, 8 hr, 10 hr and 12 hr post dose)). The study lists 2 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 NCT01984086.

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 19 Jun 2018.

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