Managing Inflammation in Chronic Obstructive Pulmonary Disease (COPD) [Mi COPD]

Phase 4

Completed

• Conditions: Chronic Obstructive Pulmonary Disease (COPD); Respiratory - Chronic obstructive pulmonary disease; Inflammatory and Immune System - Other inflammatory or immune system disorders

• Registration Number: ACTRN12613000046707
• Lead Sponsor: John Hunter Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-01-15
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 134

Inclusion Criteria

Adults with COPD, confirmed by incompletely reversible airflow obstruction (post bronchodilator FEV1 <80% predicted and FER <0.7 or physician confirmed COPD in patients with a reduced FVC), and stable disease with no recent respiratory infection, acute exacerbation, or change in maintenance therapy in the previous 4 weeks. Participants will have a history of a prior COPD exacerbation in the past year.

Exclusion Criteria

Current smoking (confirmed by history and exhaled carbon monoxide); current treatment with any macrolide, tetracycline or OCS in the preceding month, hypersensitivity to macrolides, pregnancy/breast feeding, inability to attend study visits, impaired liver function at screening as shown by AST, ALT, alkaline phosphatase or total bilirubin greater than the 2 times upper limit of normal. Participants will be excluded if there is prolongation of the QTc interval (480mS) or significant hearing impairment.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Health related quality of life as assessed by the St George Respiratory Questionnaire, specifically the proportion in each group with a clinically significant improvement (>4 units).[Baseline, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 12 months and 18 months.]