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Azithromycin in Idiopathic Pulmonary Fibrosis

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ClinicalTrials.gov Identifier: NCT02173145
Recruitment Status : Completed
First Posted : June 24, 2014
Last Update Posted : August 28, 2019
Sponsor:
Collaborator:
University of Bern
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Idiopathic Pulmonary Fibrosis Cough Drug: azithromycin Drug: placebo Not Applicable

Detailed Description:

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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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Azithromycin for the Treatment of Cough in Idiopathic Pulmonary Fibrosis- a Clinical Trial
Actual Study Start Date : August 19, 2014
Actual Primary Completion Date : August 16, 2019
Actual Study Completion Date : August 16, 2019


Arm Intervention/treatment
Active Comparator: Azithromycin first, Placebo second
Medication with Azithromycin 500mg/d 3x/week p.o. o.d. for 12 weeks or placebo.
Drug: azithromycin
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.

Drug: placebo
Placebo will be given 3 times a wek over a period of 3 months.

Active Comparator: Placebo first, Azithromycin second
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
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.

Drug: placebo
Placebo will be given 3 times a wek over a period of 3 months.




Primary Outcome Measures :
  1. Number of patients with a subjective response to treatment [ Time Frame: 3 months ]
    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.


Secondary Outcome Measures :
  1. Number of patients with an objective response to treatment [ Time Frame: 3 months ]
    Objective response is defined as the Overall response in the measured cough frequency by respiratory Polygraph (Resmed, Nox T3®).

  2. Number of patients with a change in lung function [ Time Frame: 3 months ]
    Measured by FEV1, FVC, TLC, & DLCO

  3. Number of patients with a change in oxygen saturation [ Time Frame: 3 months ]
    Measured by oxygen desaturation on exertion

  4. Number of patients with a change in quality of life [ Time Frame: 3 months ]
    Measured by quality of life questionnaires

  5. Number of patients with changes in oropharyngeal flora [ Time Frame: 3 months ]
  6. Number of patients with a change in 6 min walking distance [ Time Frame: 3 months ]
    Measured by oxygen desaturation on 6-min walking distance



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02173145


Locations
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Switzerland
Universitätsspital Basel
Basel, Switzerland
University Hospital for Pulmonology
Berne, Switzerland, 3010
Kantonsspital St. Gallen
St. Gallen, Switzerland
Universitätsspital Zürich
Zürich, Switzerland
Sponsors and Collaborators
University Hospital Inselspital, Berne
University of Bern
Investigators
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Principal Investigator: Manuela Funke, MD University Hospital for Pulmonology, Berne
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT02173145    
Other Study ID Numbers: 002/14
First Posted: June 24, 2014    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019
Keywords provided by University Hospital Inselspital, Berne:
idiopathic pulmonary fibrosis
cough
immunomodulation
macrolide
Additional relevant MeSH terms:
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Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Azithromycin
Cough
Fibrosis
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Signs and Symptoms, Respiratory
Idiopathic Interstitial Pneumonias
Lung Diseases, Interstitial
Anti-Bacterial Agents
Anti-Infective Agents