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
Condition: Asthma
MeSH terms: Asthma
Intervention: Terbutaline sulphate; Terbutaline sulphate; Placebo for terbutaline sulphate; Placebo for terbutaline sulphate
Intervention description: Bricanyl Turbuhaler M2; Bricanyl Turbuhaler M3; Placebo Turbuhaler M2; Placebo Turbuhaler M3
Intervention MeSH terms: Terbutaline
Phase: Phase 3
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 95.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Inhalation, Pharmacodynamic, Patients,

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
    

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             be withdrawn from the study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 If not, the patient will be withdrawn from the study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).