A double-blind, randomised, placebo-controlled study of roxithromycin and doxycycline combination, roxithromycin alone, or matching placebo for 12 weeks in adults with frequent exacerbations of chronic obstructive pulmonary disease

Not Applicable

Completed

• Conditions: Chronic obstructive pulmonary disease; Exacerbations of chronic obstructive pulmonary disease; Respiratory - Chronic obstructive pulmonary disease

• Registration Number: ACTRN12615000052538
• Lead Sponsor: Hoechst Marion Roussel Pty Ltd (Sanofi-Aventis Australia Pty Ltd)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-01-22
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 312

Inclusion Criteria

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).

Exclusion Criteria

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;
Epilepsy;
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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Frequency of moderate and severe exacerbations of COPD. This is a composite primary outcome of the number of moderate and severe exacerbations of COPD. An acute exacerbation was defined by either at least 2 out of 3 of the following, on 3 consecutive days or more, change in sputum production; change in sputum purulence; and change in breathlessness; or diagnosed and treated by the investigator based on clinical symptoms. Exacerbation severity was defined as ‘mild’ if it was self-managed by the patient at home (e.g. increase in bronchodilator and/or non-prescription medication use); ‘moderate’ if it required treatment with antibiotic and/or an increase in dose of, or initiation of corticosteroids by a medical practitioner; or ‘severe’ if it resulted in hospitalisation or death due to an exacerbation of COPD. The number of exacerbations will be determined from the daily diary card provided to the subjects and from the investigator assessment during any study visits.[48-week post treatment period]