In adults with frequent exacerbations of chronic obstructive pulmonary disease, does roxithromycin alone or in combination with doxycycline for 12 weeks, compared with matching placebo, reduce rate of exacerbations?

Hoechst Marion Roussel Pty Ltd (Sanofi-Aventis Australia Pty Ltd)0 个研究点目标入组 312 人开始时间: 2015年1月22日最近更新: 2020年1月13日

适应症

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•Subjects aged 45 years or older;
•Meeting spirometric criteria for COPD (FEV1 less than or equal to 70% of predicted, ratio of FEV1 over FVC (FEV1/FVC) greater than or equal to 60%, reversibility of less than or equal to10% of predicted FEV1 or less than or equal to 200ml if predicted FEV1 less than or equal to 2L);
•Smoking history greater than or equal to 20 pack years;
•At least three confirmed moderate or severe COPD exacerbations in the past two years (i.e. requiring treatment with antibiotics and/or oral corticosteroids and/or hospitalisation);
•Positive serology for C. pneumoniae (IgG antibody titre greater than or equal to 1:64).

•Pulmonary disease other than COPD;
•Treatment with antibiotics, exacerbation or an investigational drug in the four weeks before randomisation;
•Pregnancy (serum pregnancy test) or breast feeding;
•History of hypersensitivity to macrolides, tetracyclines, beta-lactams or sulfamethoxazole:trimethoprim;
•Serious cardiovascular, hepatic, renal or other systemic diseases;
•Known long QT syndrome or corrected QT interval (QTc) greater than 450ms, sick sinus syndrome, bradycardia (less than 50 beats per minute) or severe hypokalaemia;
•Treatment with medicine known to have important interaction with macrolides or tetracyclines;
•Impaired hepatic function (aspartate aminotransferase or alanine aminotransferase greater than or equal to 2 times of the upper limit of normal (ULN), alkaline phosphatase greater than or equal to 1.25 times the ULN, bilirubin greater than 2 times the ULN and albumin less than 30g/L);
•Or unlikely to comply.

发起方

Hoechst Marion Roussel Pty Ltd (Sanofi-Aventis Australia Pty Ltd)