Skip to content

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

A randomized double blind parallel group comparative 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

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2011/091/000182
Enrollment
60
Registered
2011-03-03
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Chronic Obstructive Pulmonary Disease Health Condition 2: J441- Chronic obstructive pulmonary disease with (acute) exacerbation

Interventions

Intervention1: Metered dose inhaler containing Ciclosonide 200 mcg, Tiotropium Bromide 9 mcg and Formoterol 6 mcg: Drug will be given one puff once a day for 3 months Control Intervention1: Metered do

Sponsors

Research project grant of Government of Gujarat
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Pulmonary function test (FEV1 and FVC)Timepoint: Prospective

Secondary

MeasureTime frame
Six minute walk distance (6MWD)Timepoint: Prospective

Countries

India

Contacts

Public ContactDr CB Tripathi

GMC BHAVNAGAR

cbrtripathi@yahoo.co.in09825951678

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026