A Prospective, Randomized, Open-label, Investigator-initiated Study to Evaluate the Short-term and Long-term Efficacy and Safety of Deflazacort Tablets, Prednisolone Tablets and Methylprednisolone Tablets in Patients with COPD

okmanya Medical Research Center0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•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

•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

发起方

okmanya Medical Research Center