An interventional study of azithromycin and placebo in Idiopathic Pulmonary Fibrosis and Cough, sponsored by Insel Gruppe AG, University Hospital Bern. Completed at 4 sites in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-08-28.
Sponsored by Insel Gruppe AG, University Hospital Bern · Not applicable, Interventional, and Treatment
Idiopathic pulmonary fibrosis (IPF) is a devastating disease with no cure available. Patients suffer from respiratory symptoms including dyspnea and cough. To improve life quality the investigators will test the effects of immunomodulation of macrolides specifically on cough in IPF patients. The investigators hypothesize that immunomodulatory treatment reduces cough frequency and might improve lung function.
Background
Idiopathic pulmonary fibrosis is a progressive interstitial lung disease, which ultimately leads to respiratory failure and death. The median survival is 2-3 years and thus comparable to the survival of a malignant disease. Today, there is no cure available. Improvement of quality of life (QoL) is thus a major goal in IPF patients. Cough is a common distressing and debilitating symptom in IPF. Increased cough in IPF patients may be linked to functional upregulation of lung sensory neurones. In addition, cough independently predicts disease progression in IPF patients. Symptomatic treatment options for cough in IPF are limited. Dysregulation of the immune system has been suggested to cause IPF associated cough and treatment trials with immunomodulating agents have been promising. Unfortunately the recently studied medication thalidomide is famous for its side effects and might be apprehensively received by some patients.
Immunomodulatory effects of macrolide treatment in chronic inflammatory diseases as well as reduced cough reflex in animal studies suggest a possible reduction in cough in IPF patients. In addition, in animal in vivo models azithromycin also showed anti-fibrotic properties.
The investigators hypothesize that immunomodulatory treatment of IPF patients with AZT reduces cough frequency and might improve lung function.
Objective
The purpose of this protocol is to determine the effect of azithromycin (AZT) on subjective and objective cough, QoL and lung function, its effects on biomarkers as well as its safety in patients with idiopathic pulmonary fibrosis.Specific Objectives
Methods
Single center, prospective, randomized, double blind, 2 treatments, 2 period crossover study with two 12-week treatment periods separated by a 4-week drug-free washout period and a 4 week follow-up period performed at the University Hospital Berne. All patients will be treated with both AZT and placebo. Individual changes in clinical symptoms with focus on cough frequency, life quality, lung function and adverse events will be monitored.
680 studies on the registry are indexed under Pulmonary Fibrosis; 119 are open to participants now.
This study's enrollment of 27 is below the median of 50 across 419 interventional studies indexed under Pulmonary Fibrosis.
Browse Pulmonary Fibrosis studies →Insel Gruppe AG, University Hospital Bern is the lead sponsor of 724 studies on the registry; 177 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria
Medication with Azithromycin 500mg/d 3x/week p.o. o.d. for 12 weeks or placebo.
Drug: azithromycin · Drug: placebo
Medication with Azithromycin 500mg/d 3x/week p.o. o.d. for 12 weeks or placebo. Placebo will be capsulated similar to verum and given 3 times a week.
Drug: azithromycin · Drug: placebo
Azithromycin is a macrolide antibiotic. 500mg Azithromycin will be given p.o. 3 times a week for 3 months. Azithromycin will be compared to placebo.
Placebo will be given 3 times a wek over a period of 3 months.
Number of patients with a subjective response to treatment
Subjective response is defined as a 1.3 unit reduction of cough as measured with the Leicester Cough Score from treatment start to 12 weeks of treatment.
Time frame: 3 months
Number of patients with an objective response to treatment
Objective response is defined as the Overall response in the measured cough frequency by respiratory Polygraph (Resmed, Nox T3®).
Time frame: 3 months
Number of patients with a change in lung function
Measured by FEV1, FVC, TLC, \& DLCO
Time frame: 3 months
Number of patients with a change in oxygen saturation
Measured by oxygen desaturation on exertion
Time frame: 3 months
Number of patients with a change in quality of life
Measured by quality of life questionnaires
Time frame: 3 months
Number of patients with changes in oropharyngeal flora
Time frame: 3 months
Number of patients with a change in 6 min walking distance
Measured by oxygen desaturation on 6-min walking distance
Time frame: 3 months
This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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Insel Gruppe AG, University Hospital Bern