Study of the efficacy and safety of Tiotropium bromide,in patients with COPD.
- Conditions
- Health Condition 1: null- In patients with COPD
- Registration Number
- CTRI/2017/10/010024
- Lead Sponsor
- Rus Biopharm LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1 Male and female patients 40 to 75 years of age.
2 Diagnosis of COPD established according to the GOLD guidelines (2015) not less than 12 months prior to the screening visit.
3 COPD assessment test (CAT) score >= 10.
4 Number of exacerbations per year: 0 â?? 1.
5 Patientâ??s consent to use reliable methods of contraception throughout the study and for 3 weeks after the study
1 Hypersensitivity to atropine, its derivatives (ipratropium, oxitropium) or to any component of the study drugs.
2 Lactose intolerance, lactase deficiency, or glucose - galactose malabsorption.
3 Use of oral or parenteral glucocorticoids (GC) within 2 months prior to the screening visit (3 months for prolonged-release parenteral GC).
4 A history of cystic fibrosis, bronchiectasis, pneumoconiosis, or other impairment of pulmonary ventilation.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method FEV1Timepoint: change at Visit 4
- Secondary Outcome Measures
Name Time Method Absolute PEF valueTimepoint: Changes in the absolute PEF value by Visits 2, 3, and 4.;Dyspnoea severity scoreTimepoint: Changes in the dyspnoea severity score assessed with the MRC scale by Visits 2, 3, and 4.;FEV1Timepoint: Changes at Visits 2, 3, and 4;Proportion of patients with exacerbated diseaseTimepoint: Proportion of patients with exacerbated disease at Visits 2, 3, and 4;Total CAT scoreTimepoint: Changes in the total CAT score by Visits 2, 3, and 4.