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

• Conditions: Asthma; MedDRA version: 17.1Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2014-001457-16-NL
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02-12
• Last Update Posted: 25 January 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

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 If not, the patient will be withdrawn from the study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 If not, the patient will be withdrawn from the study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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified