Health Condition 1: null- In patients with COPD
Conditions
Interventions
Intervention1: Tiotropium bromide
Inhalation powder capsules, 18 μg, supplied with an inhaler
: Manufacturer Sava Healthcare Limited, India.
Study dosing regimen 1 capsule (18 µg) per inhalation on
Sponsors
Rus Biopharm LLC
NEXUS CLINICAL RESEARCH INDIA LTD
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| FEV1Timepoint: change at Visit 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
India, Russian Federation
Contacts
Public ContactDr Mangesh khadakban
Nexus Clinical Research (India) Ltd.
Outcome results
None listed