Azithromycin in Idiopathic Pulmonary Fibrosis

NCT02173145 | Completed DMC

• 1 other identifier: 002/14
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 4

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.

Conditions

Idiopathic Pulmonary Fibrosis; Cough

Keywords

idiopathic pulmonary fibrosis; cough; immunomodulation; macrolide

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months

Secondary Outcomes (6)

• Number of patients with an objective response to treatment

  3 months

• Number of patients with a change in lung function

  3 months

• Number of patients with a change in oxygen saturation

  3 months

• Number of patients with a change in quality of life

  3 months

• Number of patients with changes in oropharyngeal flora

  3 months

Study Arms (2)

Azithromycin first, Placebo second

ACTIVE COMPARATOR

Medication with Azithromycin 500mg/d 3x/week p.o. o.d. for 12 weeks or placebo.

Drug: azithromycin; Drug: placebo

Placebo first, Azithromycin second

ACTIVE COMPARATOR

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

Interventions

azithromycin DRUG

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.

Azithromycin first, Placebo second; Placebo first, Azithromycin second

placebo DRUG

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

Azithromycin first, Placebo second; Placebo first, Azithromycin second

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• University of Bern: collaborator

Study Sites (4)

Universitätsspital Basel

Basel, Switzerland

Location

University Hospital for Pulmonology

Bern, 3010, Switzerland

Location

Kantonsspital St. Gallen

Sankt Gallen, Switzerland

Location

Universitätsspital Zürich

Zurich, Switzerland

Location

Related Publications (3)

• Guler SA, Clarenbach C, Brutsche M, Hostettler K, Brill AK, Schertel A, Geiser TK, Funke-Chambour M. Azithromycin for the Treatment of Chronic Cough in Idiopathic Pulmonary Fibrosis: A Randomized Controlled Crossover Trial. Ann Am Thorac Soc. 2021 Dec;18(12):2018-2026. doi: 10.1513/AnnalsATS.202103-266OC.

  PMID: 34015241 DERIVED

• Rindlisbacher B, Schmid C, Geiser T, Bovet C, Funke-Chambour M. Serum metabolic profiling identified a distinct metabolic signature in patients with idiopathic pulmonary fibrosis - a potential biomarker role for LysoPC. Respir Res. 2018 Jan 10;19(1):7. doi: 10.1186/s12931-018-0714-2.

  PMID: 29321022 DERIVED

• Rindlisbacher B, Strebel C, Guler S, Kollar A, Geiser T, Martin Fiedler G, Benedikt Leichtle A, Bovet C, Funke-Chambour M. Exhaled breath condensate as a potential biomarker tool for idiopathic pulmonary fibrosis-a pilot study. J Breath Res. 2017 Nov 29;12(1):016003. doi: 10.1088/1752-7163/aa840a.

  PMID: 28775244 DERIVED

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis; Cough

Interventions

Azithromycin

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals

Study Officials

• Manuela Funke, MD

  University Hospital for Pulmonology, Berne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2014
• First Posted: June 24, 2014
• Study Start: August 19, 2014
• Primary Completion: August 16, 2019
• Study Completion: August 16, 2019
• Last Updated: August 28, 2019

Record last verified: 2019-08

Locations

CH (4)