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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

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Asthma

Intervention: Terbutaline sulphate (Drug); Terbutaline sulphate (Drug); Placebo for terbutaline sulphate (Drug); Placebo for terbutaline sulphate (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Göran Eckerwall, MD, Study Director, Affiliation: AstraZeneca Mölndal, Sweden
Leif Bjermer, MD, Professor, Principal Investigator, Affiliation: Skånes University hospital, Lund

Overall contact:
AstraZeneca Clinical Study Information Center, US, Phone: 1-877-240-9479, Email: information.center@astrazeneca.com

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

Clinical Details

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

Primary outcome: PC20 (Methacholine provocative concentration causing a 20% drop in FEV1)

Secondary outcome: Adverse Events/Serious Adverse Events

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.

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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).

Locations and Contacts

AstraZeneca Clinical Study Information Center, US, Phone: 1-877-240-9479, Email: information.center@astrazeneca.com

Research Site, Quebec, Canada; Recruiting

Research Site, Groningen, Netherlands; Recruiting

Research Site, Goteborg, Sweden; Withdrawn

Research Site, Lund, Sweden; Recruiting

Research Site, Hamilton, Ontario, Canada; Recruiting

Additional Information

Starting date: March 2015
Last updated: August 13, 2015

Page last updated: August 23, 2015

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