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Azithromycin in Idiopathic Pulmonary Fibrosis

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Age ≥ 18 years - Idiopathic pulmonary fibrosis; new diagnosis, or known.
Diagnosis according to the current guidelines from ATS/ERS for IPF diagnosis, other differential diagnoses ruled out. - Clinical symptoms of cough - Written informed consent for study participation Exclusion Criteria - Previous history of an adverse reaction or allergy on azithromycin or other macrolide or ketolide antibiotics or any other ingredient (e.g. lactose) - Evidence of respiratory infection or systemic infection one month before randomisation - Known rhythmogenic heart disease - Pregnancy or lactation - History of non-compliance to medical treatment - Current alcohol or drug abuse - Active hepatitis, history of hepatitis, other significant liver disease - Serum bilirubin > 50 μmol/L - Transaminases or alkaline phosphatase elevated > 3x upper limit of normal at baseline - Severe renal insufficiency with GFR <10ml/min - Concomitant treatment with ergotamines - Concomitant treatment with ciclosporin - Concomitant treatment with ributin - Concomitant treatment with digoxin - Change of medication until 4 weeks before randomisation - Pirfenidone <3 Mo

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT02173145
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University Hospital Inselspital, Berne
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Manuela Funke, MD
Principal Investigator Affiliation University Hospital for Pulmonology, Berne
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Switzerland
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Idiopathic Pulmonary Fibrosis, Cough
Additional Details

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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International Sites

University Hospital for Pulmonology, Berne, Switzerland

Status

Recruiting

Address

University Hospital for Pulmonology

Berne, , 3010

Site Contact

Manuela Funke, MD

manuela.funke-chambour@insel.ch

031 632 21 11