Study to compare the efficacy and safety of Deflazacort tablets versus Prednisolone Tablets versus Methylprednisolone Tablets in patients with Chronic Obstructive Pulmonary Disease (COPD)

Not Applicable

• Conditions: Health Condition 1: J449- Chronic obstructive pulmonary disease, unspecified

• Registration Number: CTRI/2020/08/027069
• Lead Sponsor: okmanya Medical Research Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Adult male or female with COPD aged between 18 to 65 years (both ages inclusive) requiring

oral corticosteroid treatment

2. Patient having FEV1 more than or equal to 45% of predicted normal value

3. Patients having FEV1/FVC ratio less than 0.70

4. Patients with CRP level more than 3 mg/L

5. Patients should be on stable COPD treatment regimen for at least 4 weeks prior to screening

6. Patients who have not used tobacco products (i.e., cigarettes, cigars, pipe tobacco) within the past

year and has less than or equal to 10 pack years of historical use

7. Ability to withhold stable COPD treatment and quick-relief treatment for at least 12 h before

spirometry, in the opinion of the Investigator

8. Women of childbearing potential must be willing to consistently use an appropriate method of

contraception

9. Patients willing to give their written informed consent to participate in the study

10. Patients willing to comply with all aspects of the protocol

11. Ability to follow training given for study related procedures and assessments in the opinion of

the Investigator

Exclusion Criteria

1. Patients who require continuous daily oxygen therapy

2. Concurrent use of medications (except quick-relief) having significant drug-interaction with

study treatment affecting COPD condition or which may affect safety of the patient or interfere

with study results in the opinion of the Investigator

3. Patients suffering from rheumatologic disorders

4. Significant chronic respiratory disease other than COPD which may affect the safety of the

patient or interfere with study results in the opinion of the Investigator

5. History of behavioral and mood disturbances which may include euphoria, insomnia, mood

swings, personality changes, severe depression, and psychosis

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the efficacy of Deflazacort, Prednisolone and Methylprednisolone in patients with COPD as assessed by FEV1, FVC and FEV1/FVC% measured after short term treatment from baselineTimepoint: 8 Days

Secondary Outcome Measures

Name	Time	Method
To evaluate efficacy of Deflazacort, Prednisolone and Methylprednisolone in patients with COPD as assessed by change in C-reactive protein (CRP) levels after short term treatment from baselineTimepoint: 3 Weeks