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Clinical trial

A Study to Evaluate the Anti-inflammatory Effects of Solithromycin in Chronic Obstructive Pulmonary Disease

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Last updated:1st Oct 2015

This study examines the potential benefit of a new antibiotic, Solithromycin, for the long-term treatment of Chronic Obstructive Pulmonary Disease (COPD). Solithromycin is hypothesised to work by reducing inflammation in the lungs of patients with COPD. Stable COPD patients will receive treatment with solithromycin for 28 days and comparisons will be made between any effects observed with Solithromycin and a placebo. This will include any changes in inflammatory proteins, lung function and reported symptoms.


Study Type: Interventional
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Single-center, Double-blind, Randomised, Placebo-controlled Crossover Study to Evaluate the Effect of Solithromycin on Airway Inflammation in Male and Female Patients With Chronic Obstructive Pulmonary Disease
Estimated Enrollment: 30
Study Start Date: October 2015
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)

Arms:
- Experimental:
Solithromycin
- Placebo Comparator: Placebo

Category Value
Study start date 2015-10-01

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