Study of the efficacy and safety of Tiotropium bromide,in patients with COPD.

Not yet recruiting

• Conditions: In patients with COPD

• Registration Number: CTRI/2017/10/010024
• Lead Sponsor: Rus Biopharm LLC

Brief Summary

The study will be conducted as an open-label, multicentre, randomized,comparative trial.

**The total duration of the study for each patient** will notexceed 109 days, of which the duration of screening will not exceed 14 days, the duration of the treatment period - 84 days, and the duration ofthe follow-up period - 11 days.

**Visits**

Visit 0 (screening, Day -14 ... -1); Visit 1 (randomization, Day 1) ; Visit 2 (interim visit, 28 ± 2 days); Visit 3 (interim visit, 56 ± 2 days); Visit 4 (completion of therapy, 86 ± 2 days); Visit 5 (telephonecall, 93 ± 2 days).

**The 1st group** of patients will receive 1 inhalation (one capsule) ofTiotropium bromide, inhalation powder capsules, 18 µg (Sava Healthcare Limited,India), once daily (at the same time) for 84 days, performed using an inhaler.

**The 2nd group** of patients willreceive 1 inhalation (one capsule) of Spiriva®, inhalation powdercapsules, 18 µg (Boehringer Ingelheim Pharma GmbH & Co. KG, Germany), oncedaily (at the same time) for 84 days, performed using an inhaler.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-21
• Last Update Posted: 2018-07-30

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 150

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 – 1.
• 5 Patient’s consent to use reliable methods of contraception throughout the study and for 3 weeks after the study.

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
FEV1	change at Visit 4

Secondary Outcome Measures

Name	Time	Method
FEV1	Changes at Visits 2, 3, and 4
Proportion of patients with exacerbated disease	Proportion of patients with exacerbated disease at Visits 2, 3, and 4
Absolute PEF value	Changes in the absolute PEF value by Visits 2, 3, and 4.
Total CAT score	Changes in the total CAT score by Visits 2, 3, and 4.
Dyspnoea severity score	Changes in the dyspnoea severity score assessed with the MRC scale by Visits 2, 3, and 4.

Trial Locations

Locations (1)

Hi Tech Medical College & Hospital; 🇮🇳 Khordha, ORISSA, India

Hi Tech Medical College & Hospital

🇮🇳Khordha, ORISSA, India

Dr S Behera

Principal investigator

9439129178

behera.saiprasanna82@gmail.com