A clinical study to evaluate efficacy and safety of inhaled corticosteroids in mild to moderate cases of Chronic Obstructive Pulmonary Disease

Phase 4

Completed

• Conditions: Chronic obstructive pulmonary disease with (acute) exacerbation,

• Registration Number: CTRI/2011/091/000182
• Lead Sponsor: Research project grant of Government of Gujarat

Brief Summary

There will be 70 patients in the study. This is randomized, double blind, active control, parallel group, single centre, study to evaluate efficacy and safety of triplet combination (Ciclosonide, Tiotropium bromide and Formoterol) and dual combination (Tiotropium bromide and Formoterol) in mild to moderate cases of Chronic Obstructive Pulmonary Disease. It will be done in India. Primary outcome measures will be pulmonary function test (FEV1 and FVC) at one month interval for three months.Secondary outcome measures will be exercise tolerance (Six minute walk distance) at one month interval for three months.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01-13
• Last Update Posted: 2019-11-18

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Age between 35 to 70 years of either sex Clinically diagnosed mild to moderate COPD as per GOLD guideline (FEV1 more than 50 FEV1 and FVC ratio less than 0.7) Ability to give written informed consent Smokers and ex-smokers more and equal to 10 pack per years.

Exclusion Criteria

Patients on oral steroid History Of significant illness of other system especially cardiovascular system History of exacerbation in run in period Patients having other serious respiratory illness ( tuberculosis asthma) other than COPD History of long acting antihistaminic within 1 week History of Hypersensitivity to study medications Contraindication to six minute walk test Do not give informed consent.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pulmonary function test (FEV1 and FVC)	Prospective

Secondary Outcome Measures

Name	Time	Method
Six minute walk distance (6MWD)	Prospective

Trial Locations

Locations (1)

Sir Takhtsinhji General Hospital, Bhavnagar, Gujarat; 🇮🇳 Bhavnagar, GUJARAT, India

Sir Takhtsinhji General Hospital, Bhavnagar, Gujarat

🇮🇳Bhavnagar, GUJARAT, India

Dr. C.B. Tripathi

Principal investigator

09825951678

cbrtripathi@yahoo.co.in