ong term safety and tolerability of NVA237 versus tiotropium in Japanese patients
- Conditions
- Chronic obstructive pulmonary disease
- Registration Number
- JPRN-jRCT2080221091
- Lead Sponsor
- ovartis Pharma K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 160
Patients with moderate to severe stable COPD Stage II or Stage III) according to the Gold Guideline 2008.
Current or ex-smokers who have a smoking history of at least 10 pack years.
Patients with a post-bronchodilator FEV1 >= 30% and < 80% of the predicted normal, and postbronchodilator FEV1/FVC < 0.7
Pregnant women or nursing mothers or women of child-bearing potential not using an acceptable method of contraception
Patients requiring long term oxygen therapy
Patients who have had a lower respiratory tract infection within 6 weeks prior to Visit 1
Patients with concomitant pulmonary disease
Patients with a history of asthma
Any patient with lung cancer or a history of lung cancer
Patients with a history of certain cardiovascular comorbid conditions
Patients with a known history and diagnosis of alpha-1 antitrypsin deficiency
Patients in the active phase of a supervised pulmonary rehabilitation program
Patients contraindicated for tiotropium or ipratropium treatment or who have shown an untoward reaction to inhaled anticholinergic agents
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method