Azithromycin in Idiopathic Pulmonary Fibrosis

• Status: Completed
• Trial end date: 2019-08-16
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Inselspital, Berne
• Collaborator: University of Bern
• Treatments: Azithromycin

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