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

NCT ID: NCT02322788

Last Updated: 2017-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 95 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2015-11-30

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.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

Bricanyl Turbuhaler M2, Active

Terbutaline sulphate powder for inhalation, 0.5 mg terbutaline per inhalation

Group Type: ACTIVE_COMPARATOR

Terbutaline sulphate

Intervention Type: DRUG

Bricanyl Turbuhaler M2

Bricanyl Turbuhaler M3, Active

Terbutaline sulphate powder for inhalation, 0.4 mg terbutaline per inhalation

Group Type: ACTIVE_COMPARATOR

Terbutaline sulphate

Intervention Type: DRUG

Bricanyl Turbuhaler M3

Turbuhaler M2, Placebo

Placebo powder for inhalation

Group Type: PLACEBO_COMPARATOR

Placebo for terbutaline sulphate

Intervention Type: DRUG

Placebo Turbuhaler M2

Turbuhaler M3, Placebo

Placebo powder for inhalation

Group Type: PLACEBO_COMPARATOR

Placebo for terbutaline sulphate

Intervention Type: DRUG

Placebo Turbuhaler M3

Interventions

Terbutaline sulphate

Bricanyl Turbuhaler M2

Intervention Type: DRUG

Terbutaline sulphate

Bricanyl Turbuhaler M3

Intervention Type: DRUG

Placebo for terbutaline sulphate

Placebo Turbuhaler M2

Intervention Type: DRUG

Placebo for terbutaline sulphate

Placebo Turbuhaler M3

Intervention Type: DRUG

Other Intervention Names

Terbutaline sulphate powder for inhalation, 0.5 mg (metered dose) terbutaline per inhalation; Terbutaline sulphate powder for inhalation, 0.4 mg (delivered dose) terbutaline per inhalation; Placebo powder for inhalation; Placebo powder for inhalation

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Göran Eckerwall, MD

Role: STUDY_DIRECTOR

AstraZeneca Mölndal, Sweden

Leif Bjermer, MD, Professor

Role: PRINCIPAL_INVESTIGATOR

Skånes University hospital, Lund

Locations

Research Site

Hamilton, Ontario, Canada

Research Site

Québec, Quebec, Canada

Research Site

Groningen, , Netherlands

Research Site

Lund, , Sweden

Countries

Canada; Netherlands; Sweden

References

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.

Reference Type: DERIVED

PMID: 28232118 (View on PubMed)

Other Identifiers

D4711C00001

Identifier Type: -

Identifier Source: org_study_id