Back to resultsComparing 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
Primary Purpose
Asthma
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Terbutaline sulphate
Terbutaline sulphate
Placebo for terbutaline sulphate
Placebo for terbutaline sulphate
Sponsored by
About this trial
This is an interventional basic science trial for Asthma focused on measuring Inhalation, Pharmacodynamic, Patients,
Eligibility Criteria
Inclusion Criteria: - Female and male aged 18 and 65 years.
- 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 If not, the patient will be withdrawn from the study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 If not, the patient will be withdrawn from the study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
- 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).
Sites / Locations
- Research Site
- Research Site
- Research Site
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Placebo Comparator
Arm Label
Bricanyl Turbuhaler M2, Active
Bricanyl Turbuhaler M3, Active
Turbuhaler M2, Placebo
Turbuhaler M3, Placebo
Arm Description
Terbutaline sulphate powder for inhalation, 0.5 mg terbutaline per inhalation
Terbutaline sulphate powder for inhalation, 0.4 mg terbutaline per inhalation
Placebo powder for inhalation
Placebo powder for inhalation
Outcomes
Primary Outcome Measures
Provocative Concentration of Methacholine Which Produces a 20% Fall in FEV1 (PC20)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02322788
Brief Title
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
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Inhalation, Pharmacodynamic, Patients,
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
95 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bricanyl Turbuhaler M2, Active
Arm Type
Active Comparator
Arm Description
Terbutaline sulphate powder for inhalation, 0.5 mg terbutaline per inhalation
Arm Title
Bricanyl Turbuhaler M3, Active
Arm Type
Active Comparator
Arm Description
Terbutaline sulphate powder for inhalation, 0.4 mg terbutaline per inhalation
Arm Title
Turbuhaler M2, Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo powder for inhalation
Arm Title
Turbuhaler M3, Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo powder for inhalation
Intervention Type
Drug
Intervention Name(s)
Terbutaline sulphate
Other Intervention Name(s)
Terbutaline sulphate powder for inhalation, 0.5 mg (metered dose) terbutaline per inhalation
Intervention Description
Bricanyl Turbuhaler M2
Intervention Type
Drug
Intervention Name(s)
Terbutaline sulphate
Other Intervention Name(s)
Terbutaline sulphate powder for inhalation, 0.4 mg (delivered dose) terbutaline per inhalation
Intervention Description
Bricanyl Turbuhaler M3
Intervention Type
Drug
Intervention Name(s)
Placebo for terbutaline sulphate
Other Intervention Name(s)
Placebo powder for inhalation
Intervention Description
Placebo Turbuhaler M2
Intervention Type
Drug
Intervention Name(s)
Placebo for terbutaline sulphate
Other Intervention Name(s)
Placebo powder for inhalation
Intervention Description
Placebo Turbuhaler M3
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - Female and male aged 18 and 65 years.
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
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Göran Eckerwall, MD
Organizational Affiliation
AstraZeneca Mölndal, Sweden
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Leif Bjermer, MD, Professor
Organizational Affiliation
Skånes University hospital, Lund
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Quebec
Country
Canada
Facility Name
Research Site
City
Groningen
Country
Netherlands
Facility Name
Research Site
City
Lund
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
28232118
Citation
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.
Results Reference
derived
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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
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