Asthma MedDRA version: 17.1 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Product Name: terbutaline Turbuhaler® 0.4 mg/dose
Pharmaceutical Form: Inhalation powder
INN or Proposed INN: Terbutaline
CAS Number: 23031-32-5
Other descriptive name: Terbutaline sulphate
Concentrat
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion 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 If not, the patient will be withdrawn from the study - At the enrolment visits 1a or 1b (LABA patients only) and at the end of run-in period, visit 2, eligible patients should demonstrate an airway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 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to demonstrate therapeutic equivalence between Bricanyl Turbuhaler M3 and Bricanyl Turbuhaler M2 using bronchoprotective effect as outcome measure. Outcome measurements: PC20 (Methacholine provocative concentration causing a 20% drop in FEV1);Secondary Objective: Secondary objective-Safety objective is to compare safety of Bricanyl Turbuhaler M2 and Bricanyl Turbuhaler M3. Outcome measurements: AE/SAE;Primary end point(s): NA;Timepoint(s) of evaluation of this end point: NA | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): NA;Timepoint(s) of evaluation of this end point: NA | — |
Countries
Canada, Netherlands, Sweden
Contacts
Public ContactInformation Center
AstraZeneca AB
Outcome results
None listed