Azithromycin in Idiopathic Pulmonary Fibrosis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02173145
• Date of registration: 23/06/2014
• Prospective Registration: Yes
• Primary sponsor: University Hospital Inselspital, Berne
• Public title: Azithromycin in Idiopathic Pulmonary Fibrosis
• Scientific title: Azithromycin for the Treatment of Cough in Idiopathic Pulmonary Fibrosis- a Clinical Trial
• Date of first enrolment: August 19, 2014
• Target sample size: 27
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02173145
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Switzerland

Contacts

• Name: Manuela Funke, MD
• Affiliation: University Hospital for Pulmonology, Berne

Key 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Idiopathic Pulmonary Fibrosis

Cough

Intervention(s)

Drug: placebo

Drug: azithromycin

Primary Outcome(s)

Number of patients with a subjective response to treatment [Time Frame: 3 months]

Secondary Outcome(s)

Number of patients with a change in lung function [Time Frame: 3 months]

Number of patients with changes in oropharyngeal flora [Time Frame: 3 months]

Number of patients with a change in oxygen saturation [Time Frame: 3 months]

Number of patients with a change in quality of life [Time Frame: 3 months]

Number of patients with an objective response to treatment [Time Frame: 3 months]

Number of patients with a change in 6 min walking distance [Time Frame: 3 months]

Secondary ID(s)

002/14

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University of Bern