Health Condition 1: J449- Chronic obstructive pulmonary disease, unspecified
Conditions
Interventions
Intervention1: Deflazacort Tablets (Macleods Pharmaceuticals Ltd.)
: Oral Deflazacort Tablets 0.5-1.0 mg/kg/day
Investigators are allowed to adjust study treatment regimen (dose per day, frequency pe
Sponsors
Lokmanya Medical Research Center
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
India
Contacts
Public ContactDr Himanshu Shashikant Pophale
Lokmanya Medical Research Center
Outcome results
None listed