Idiopathic Pulmonary Fibrosis Clinical Trial
Official title:
Azithromycin for the Treatment of Cough in Idiopathic Pulmonary Fibrosis- a Clinical Trial
NCT number | NCT02173145 |
Other study ID # | 002/14 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | August 19, 2014 |
Est. completion date | August 16, 2019 |
Verified date | August 2019 |
Source | University Hospital Inselspital, Berne |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 27 |
Est. completion date | August 16, 2019 |
Est. primary completion date | August 16, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Switzerland | Universitätsspital Basel | Basel | |
Switzerland | University Hospital for Pulmonology | Berne | |
Switzerland | Kantonsspital St. Gallen | St. Gallen | |
Switzerland | Universitätsspital Zürich | Zürich |
Lead Sponsor | Collaborator |
---|---|
University Hospital Inselspital, Berne | University of Bern |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Number of patients with an objective response to treatment | Objective response is defined as the Overall response in the measured cough frequency by respiratory Polygraph (Resmed, Nox T3®). | 3 months | |
Secondary | Number of patients with a change in lung function | Measured by FEV1, FVC, TLC, & DLCO | 3 months | |
Secondary | Number of patients with a change in oxygen saturation | Measured by oxygen desaturation on exertion | 3 months | |
Secondary | Number of patients with a change in quality of life | Measured by quality of life questionnaires | 3 months | |
Secondary | Number of patients with changes in oropharyngeal flora | 3 months | ||
Secondary | Number of patients with a change in 6 min walking distance | Measured by oxygen desaturation on 6-min walking distance | 3 months |
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