Comparison of efficacy between long-acting muscarinic antagonist (LAMA) and leukotriene receptor antagonist (LTRA) as step-up treatment in patients with uncontrolled bronchial asthma
Phase 2
Recruiting
- Conditions
- Bronchial asthma
- Registration Number
- JPRN-UMIN000022696
- Lead Sponsor
- Second Division, Department of Internal Medicine, Hamamatsu University School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
Not provided
Exclusion Criteria
(1) Treatment with oral or intravenous corticosteroids, hospitalization, emergency or unexpected visit within 4 weeks (2) Angle closure glaucoma, symptomatic prostatic hypertrophy and uncontrolled heart failure (3) Active other pulmonary diseases except for asthma and COPD (4) Vocal cord disfunction (5) Previous history of hypersensitivity to tiotropium or montelukast (6) Pregnancy or lactation (7) Considered to be unsuitable by the physicians
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from baseline (0 week) in FEV1 after 12 weeks of treatment
- Secondary Outcome Measures
Name Time Method Secondly end points are change in QOL (ACT score, ACQ score), parameters of pulmonary function (%FEV1, FEV1/FVC, PEF, MMF, respiratory resistance, respiratory reactance), and fractional exhaled nitric oxide after 12 weeks of treatment from baseline (0 week). Adverse events are reported throughout the study.