AsthmaPhase 3NCT02322788
Comparing the Efficacy of Bricanyl M2 and Bricanyl M3 at 0.5 and 1.5 mg Dose Levels, to Allow for a Switch From Bricanyl Turbuhaler M2 to Bricanyl Turbuhaler M3
A Phase 3 study testing Terbutaline sulphate in people with Asthma, run by AstraZeneca at 4 sites in 3 countries.
Trial summary
A randomised, double-blind, double-dummy, multi-site, phase III, single dose, 4-way cross-over pharmacodynamic study evaluating the efficacy of Bricanyl Turbuhaler M3 compared to Bricanyl Turbuhaler M2 by studying the protective effect on methacholine induced bronchoconstriction in patients with stable, mild to… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- Terbutaline sulphate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 95 participants
- Where
- 4 sitesin 3 countries
- Study dates
- Mar 2015to Nov 2015
- Phase
- Phase 3
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 6 months of documented clinical diagnosis of asthma as defined by GINA 2012 or American Thoracic Society (Expert Panel Report 3 2007) prior to visit 1
- Stable asthmatics on SABA alone, on low dose ICS (200-400 µg budesonide corresponding) or on fixed combination of low ICS/LABA
- At the enrolment visit 1a, the visit baseline FEV1 must be ≥80 % of that predicted normal (NHANES III). For LABA patients the visit baseline FEV1 must be ≥80 % of that predicted normal (NHANES III) at both visit 1a and visit 1b. If not, the patient will be withdrawn from the study
- At the enrolment visits 1a or 1b (LABA patients only) and at the end of run-in period, visit 2, eligible patients should demonstrate an airway responsiveness to methacholine PC20 <8 mg/mL. If not, the patient will be withdrawn from the study
- Capable of using Turbuhaler inhalation device as judged by investigator. Exclusion Criteria: Diagnosed with COPD or history of cystic fibrosis, bronchiectasis or other respiratory diseases
- Pregnancy, breast-feeding, lactation, or planned pregnancy during the study. Fertile women not using acceptable contraceptive measures
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- Conditions which could alter airway reactivity to methacholine (e.g. pneumonia, upper respiratory tract infection, viral bronchitis and/or sinobronchitis) within past six weeks
- Exacerbation due to asthma or change in asthma medication during the last 3 months prior to enrolment
- Night time awakenings due to asthma symptoms on 2 consecutive nights during the last 4 weeks prior to enrolment
- Smokers 6 months prior to the study start or with a history of smoking of more than 10 pack years (e.g. 20 cigarettes/day for at least 10 years, or 10 cigarettes/day for at least 20 years, or equal).
Who cannot join
None listed.
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
About this study
Official title: A Randomised, Double-blind, Double-dummy, Multi-site, Phase III, Single Dose, 4-way Cross-over Pharmacodynamic Study Evaluating the Efficacy of Bricanyl Turbuhaler M3 Compared to Bricanyl Turbuhaler M2 by Studying the Protective Effect on Methacholine Induced Bronchoconstriction in Patients With Stable, Mild to Moderate Asthma
A randomised, double-blind, double-dummy, multi-site, phase III, single dose, 4-way cross-over pharmacodynamic study evaluating the efficacy of Bricanyl Turbuhaler M3 compared to Bricanyl Turbuhaler M2 by studying the protective effect on methacholine induced bronchoconstriction in patients with stable, mild to moderate asthma
Read the detailed description
The study will include female and male patients, between 18 and 65 years old, with stable, mild to moderate asthma who are on short acting β2-agonist (SABA) alone, on low dose inhaled corticosteroid (ICS) (200-400 µg budesonide or corresponding) or on a combination of low dose ICS and long acting β2-agonists (LABA). Approximately 60 patients will be randomised in order to have 49 completed.
The primary objective is to demonstrate therapeutic equivalence between Bricanyl Turbuhaler M3 and Bricanyl Turbuhaler M2 using bronchoprotective effect. Outcome measure: PC20 (Methacholine provocative concentration causing a 20% drop in FEV1). The safety objective is to compare safety of Bricanyl Turbuhaler M2 and Bricanyl Turbuhaler M3. Outcome measure Adverse Events/Serious.
Study period Q1 2015 - Q1 2016.
- Conditions
- Asthma
- Being tested
- Terbutaline sulphate, Placebo for terbutaline sulphate
- Keywords
- Inhalation, Pharmacodynamic, Patients,
- Medical subject headings
- Asthma, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Terbutaline sulphateDrug
Also called Terbutaline sulphate powder for inhalation, 0.5 mg (metered dose) terbutaline per inhalation
Bricanyl Turbuhaler M2
Terbutaline sulphateDrug
Also called Terbutaline sulphate powder for inhalation, 0.4 mg (delivered dose) terbutaline per inhalation
Bricanyl Turbuhaler M3
Placebo for terbutaline sulphateDrug
Also called Placebo powder for inhalation
Placebo Turbuhaler M2
Placebo for terbutaline sulphateDrug
Also called Placebo powder for inhalation
Placebo Turbuhaler M3
| Study group | Role | What they receive |
|---|---|---|
| Bricanyl Turbuhaler M2, Active | Active comparator | Terbutaline sulphate powder for inhalation, 0.5 mg terbutaline per inhalation Receives: Drug: Terbutaline sulphate |
| Bricanyl Turbuhaler M3, Active | Active comparator | Terbutaline sulphate powder for inhalation, 0.4 mg terbutaline per inhalation Receives: Drug: Terbutaline sulphate |
| Turbuhaler M2, Placebo | Placebo comparator | Placebo powder for inhalation Receives: Drug: Placebo for terbutaline sulphate |
| Turbuhaler M3, Placebo | Placebo comparator | Placebo powder for inhalation Receives: Drug: Placebo for terbutaline sulphate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Provocative Concentration of Methacholine Which Produces a 20% Fall in FEV1 (PC20)
Measured: 4 cross-over treatments (<1 day each) with 2-10 days between treatment washout periods
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2014 (estimated)
- Study startMar 2015
- Primary completionNov 2015
- Study completionNov 2015
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 AstraZenecaThe 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 3
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Göran Eckerwall, MD, Study director, AstraZeneca Mölndal, SwedenLeif Bjermer, MD, Professor, Principal investigator, Skånes University hospital, Lund
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02322788
- Sponsor's protocol ID
- D4711C00001
- Status last verified
- Nov 2016
- First submitted
- 26 Nov 2014
- Last updated
- 13 Jan 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Bjermer L, Gauvreau GM, Postma DS, O'Byrne PM, van den Berge M, Boulet LP, Beckman O, Persson T, Roman J, Carlholm M, Schutzer KM, Eckerwall G. Methacholine challenge tests to demonstrate therapeutic equivalence of terbutaline sulfate via different Turbuhaler(R) devices in patients with mild to moderate asthma: Appraisal of a four-way crossover design. Pulm Pharmacol Ther. 2017 Jun;44:1-6. doi: 10.1016/j.pupt.2017.02.004. Epub 2017 Feb 20.
PubMed 28232118
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 Randomised, Double-blind, Double-dummy, Multi-site, Phase III, Single Dose, 4-way Cross-over Pharmacodynamic Study Evaluating the Efficacy of Bricanyl Turbuhaler M3 Compared to Bricanyl Turbuhaler M2 by Studying the Protective Effect on Methacholine Induced Bronchoconstriction in Patients With Stable, Mild to Moderate Asthma
- ClinicalTrials.gov ID
- NCT02322788
- Acronym / sponsor ID
- D4711C00001
- Conditions
- Asthma
- Keywords
- Inhalation, Pharmacodynamic, Patients,
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Mar 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 23 Dec 2014 (estimated)
- Results
- Posted 7 Nov 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomised, double-blind, double-dummy, multi-site, phase III, single dose, 4-way cross-over pharmacodynamic study evaluating the efficacy of Bricanyl Turbuhaler M3 compared to Bricanyl Turbuhaler M2 by studying the protective effect on methacholine induced bronchoconstriction in patients with stable, mild to moderate asthma
Detailed description
The study will include female and male patients, between 18 and 65 years old, with stable, mild to moderate asthma who are on short acting β2-agonist (SABA) alone, on low dose inhaled corticosteroid (ICS) (200-400 µg budesonide or corresponding) or on a combination of low dose ICS and long acting β2-agonists (LABA). Approximately 60 patients will be randomised in order to have 49 completed.
The primary objective is to demonstrate therapeutic equivalence between Bricanyl Turbuhaler M3 and Bricanyl Turbuhaler M2 using bronchoprotective effect. Outcome measure: PC20 (Methacholine provocative concentration causing a 20% drop in FEV1). The safety objective is to compare safety of Bricanyl Turbuhaler M2 and Bricanyl Turbuhaler M3. Outcome measure Adverse Events/Serious.
Study period Q1 2015 - Q1 2016.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Bricanyl Turbuhaler M2, Active | Active comparator | Drug: Terbutaline sulphateTerbutaline sulphate powder for inhalation, 0.5 mg terbutaline per inhalation |
| Bricanyl Turbuhaler M3, Active | Active comparator | Drug: Terbutaline sulphateTerbutaline sulphate powder for inhalation, 0.4 mg terbutaline per inhalation |
| Turbuhaler M2, Placebo | Placebo comparator | Drug: Placebo for terbutaline sulphatePlacebo powder for inhalation |
| Turbuhaler M3, Placebo | Placebo comparator | Drug: Placebo for terbutaline sulphatePlacebo powder for inhalation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- At least 6 months of documented clinical diagnosis of asthma as defined by GINA 2012 or American Thoracic Society (Expert Panel Report 3 2007) prior to visit 1
- Stable asthmatics on SABA alone, on low dose ICS (200-400 µg budesonide corresponding) or on fixed combination of low ICS/LABA
- At the enrolment visit 1a, the visit baseline FEV1 must be ≥80 % of that predicted normal (NHANES III). For LABA patients the visit baseline FEV1 must be ≥80 % of that predicted normal (NHANES III) at both visit 1a and visit 1b. If not, the patient will be withdrawn from the study
- At the enrolment visits 1a or 1b (LABA patients only) and at the end of run-in period, visit 2, eligible patients should demonstrate an airway responsiveness to methacholine PC20 <8 mg/mL. If not, the patient will be withdrawn from the study
- Capable of using Turbuhaler inhalation device as judged by investigator. Exclusion Criteria: Diagnosed with COPD or history of cystic fibrosis, bronchiectasis or other respiratory diseases
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Terbutaline sulphateAlso: Terbutaline sulphate powder for inhalation, 0.5 mg (metered dose) terbutaline per inhalationBricanyl Turbuhaler M2 | Drug | Bricanyl Turbuhaler M2, Active |
| Terbutaline sulphateAlso: Terbutaline sulphate powder for inhalation, 0.4 mg (delivered dose) terbutaline per inhalationBricanyl Turbuhaler M3 | Drug | Bricanyl Turbuhaler M3, Active |
| Placebo for terbutaline sulphateAlso: Placebo powder for inhalationPlacebo Turbuhaler M2 | Drug | Turbuhaler M2, Placebo |
| Placebo for terbutaline sulphateAlso: Placebo powder for inhalationPlacebo Turbuhaler M3 | Drug | Turbuhaler M3, Placebo |
Primary outcome
Provocative Concentration of Methacholine Which Produces a 20% Fall in FEV1 (PC20)
Time frame: 4 cross-over treatments (<1 day each) with 2-10 days between treatment washout periods
Results and safety
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.
- Derived from this study: PubMed 28232118Bjermer L, Gauvreau GM, Postma DS, O'Byrne PM, van den Berge M, Boulet LP, Beckman O, Persson T, Roman J, Carlholm M, Schutzer KM, Eckerwall G. Methacholine challenge tests to demonstrate therapeutic equivalence of terbutaline sulfate via different Turbuhaler(R) devices in patients with mild to moderate asthma: Appraisal of a four-way crossover design. Pulm Pharmacol Ther. 2017 Jun;44:1-6. doi: 10.1016/j.pupt.2017.02.004. Epub 2017 Feb 20.
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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.
Göran Eckerwall, MD study director
AstraZeneca Mölndal, Sweden
Leif Bjermer, MD, Professor principal investigator
Skånes University hospital, Lund
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Terbutaline sulphate in people with Asthma, run by AstraZeneca at 4 sites in 3 countries.
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 10 inclusion and 0 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 4 sites in Canada, Netherlands, Sweden. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 7 Nov 2016). 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?
Provocative Concentration of Methacholine Which Produces a 20% Fall in FEV1 (PC20) (time frame: 4 cross-over treatments (<1 day each) with 2-10 days between treatment washout periods). 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 NCT02322788, 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 13 Jan 2017.