Idiopathic Pulmonary Fibrosis Clinical Trial
Official title:
Azithromycin for the Treatment of Cough in Idiopathic Pulmonary Fibrosis- a Clinical Trial
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
1. To determine the efficiency after 12 weeks of treatment on subjective and objective
cough reduction and increase of QoL
2. To monitor safety by recording severe adverse events, including mortality,
organ-specific toxicities and exacerbations requiring hospitalization
3. To test efficiency at 12 weeks with overall response measured by changes in FEV1, FVC,
TLC, DLCO, oxygen desaturation on exertion and 6-min walking distance
4. To determine efficiency in clinical course
5. To monitor overall adverse events
6. To determine the influence on cytokines and biomarkers in IPF
7. To determine the impact on oro-pharyngeal flora and antibiotical resistance
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.
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