High dose Rosuvastatin as an adjunctive treatment in acute exacerbation of chronic obstructive pulmonary disease, a randomized double blind clinical trial.

Summary: 1. Objective: based on retrospective evidence, Statin therapy in chronic obstructive pulmonary disease (COPD) may have some advantages regarding the outcomes in this disease. 2. Design: the patients presented to emergency department with acute exacerbation of COPD (AECOPD) by random number table will be randomly assigned to receive either high dose Rosuvastatin (40 mg) or placebo for 14 days, . Both groups will receive classic treatment of AECOPD. The patients, physicians (who treat patients based on current guidelines recommendation) and researcher (who gathers the data) will not be aware of drug/placebo group. One researcher who is not involved in patients' management will be aware of Drug/Placebo group. The patients will be followed in 3rd , 14th, 30th and 90th day of treatment. The out of hospital follow-up will be by phone-follow up. 3. Setting and conduct: patients with previous medical history or sirometry compatible with COPD, presenting to emergency department with positive criteria for ECOPD (Dyspnea, increased sputum and/or purulent sputum) will be included in this study prospectively.The patients will receive either Placebo or Rosuvastatin. 4. Participants including major eligibility criteria: - Inclusion criteria: 1) hospitalized patients with past history compatible with AECOPD and 2 of following symptoms: Dyspnea, increased sputum and/or purulent sputum 2) Age > 40 - Exclusion criteria: 1) Acute coronary syndrome 2) history of statin therapy 3)endotracheal intubation 4) significant associated comorbidities (cardiac, renal or hepatic) 5) history of musculoskeletal disorders 6) history of intolerance to statins 5. Intervention: during first 24 hours of hospital admission the drug group patients will receive Rosuvastatin 40 mg (Ropixon® 40 mg) daily for 14 days. The placebo group will receive the drug with same shape and container (inert formula and starch) for same time period. Those who will discharge before 14 days will continue treatment at home for total 14 days.All patients will receive all other current recommended treatment of AECOPD with bronchodilators, corticosteroids and antibiotics and the study will not interfere with recommended treatments for AECOPD. 6. Main outcome measures (variables): 1) Persian version COPD assessment test (CAT) in1st 3rd and 14th day of treatment 2) modified BORG scale in 1st 3rd and 14th day of treatment 3) Arterial pulse-oximetry in 1st 3rd day of treatment 4) Arterial CO2 pressure in 1st 3rd day of treatment 5) Re-admission due to AECOPD in following 3 month 6) hospitalization period 7) ICU admission during hospital stay.

Vice chancellor for research, Tehran University of Medical Sciences