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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02322788
• Other study ID #: D4711C00001
• Status: Completed
• Phase: Phase 3
• First received: November 26, 2014
• Last updated: January 8, 2016
• Start date: March 2015
• Est. completion date: November 2015

Study information

• Verified date: January 2016
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical 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 moderate asthma

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Terbutaline sulphate
Bricanyl Turbuhaler M2
• Terbutaline sulphate
Bricanyl Turbuhaler M3
• Placebo for terbutaline sulphate
Placebo Turbuhaler M2
• Placebo for terbutaline sulphate
Placebo Turbuhaler M3

Locations

Country	Name	City	State
Canada	Research Site	Hamilton	Ontario
Canada	Research Site	Quebec
Netherlands	Research Site	Groningen
Sweden	Research Site	Lund

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Canada,  Netherlands,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PC20 (Methacholine provocative concentration causing a 20% drop in FEV1)	Methacholine challenge test will be performed using 2-minute tidal breathing method, with doubling concentrations from 0.03 mg/mL to 64 mg/mL at visits 3-6.	After 30 and 90 seconds. If 90 seconds value is not higher than 30 seconds value, additional measurement at 180 sec. will be performed.	No
Secondary	Adverse Events/Serious Adverse Events		Expected average time for AE collection is 5 weeks (from the first administration of the IP until the follow-up visit). SAEs will be collected during the whole study period, starting from signed informed consent, an expected average of 10 weeks.	Yes