Macrolide Antibiotic Therapy for Patients With Cystic Fibrosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-12-31

Study Completion Date

2004-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to evaluate whether Biaxin (clarithromycin) improves sputum abnormalities, lung function, and overall feeling of well-being in people with cystic fibrosis (CF). Biaxin is an antibiotic commonly used for the treatment of respiratory infections in people who do not have CF, and is sometimes used in CF patients as well. Studies done in a disease called diffuse panbronchiolitis (which is similar to CF) and some preliminary studies that have been done in CF patients suggest that Biaxin might have a beneficial effect on CF sputum in ways unrelated to its antibiotic activity.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Pharmacokinetics of Polymyxin B in Adult Patients With Cystic Fibrosis

NCT04335370

Cystic Fibrosis Polymyxin B

COMPLETED

Improving Treatment of Nontuberculous Mycobacterial Infection in Cystic Fibrosis

NCT02372383

Cystic Fibrosis

COMPLETED NA

Antimicrobial Resistance in Cystic Fibrosis (CF)

NCT00360503

Cystic Fibrosis

COMPLETED

Trial of Doxycycline to Reduce Sputum MMP-9 Activity in Adult Cystic Fibrosis (CF) Patients

NCT01112059

Cystic Fibrosis

COMPLETED NA

Outpatient Antibiotic Treatment for a Cystic Fibrosis Pulmonary Exacerbation

NCT02480270

Cystic Fibrosis

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cystic Fibrosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Biaxin ( clarithromycin)

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* diagnosis of CF
* ability to reliably perform spirometry
* FEV1 of 30% predicted at the time of screening

Exclusion Criteria

* Mycobacterium in a sputum culture ever recorded
* a respiratory exacerbation requiring IV antibiotics in the 60 days prior
* used a investigational drug or device in the 60 days prior
* significant (\>30ml) of hemoptysis in the past year
* require oxygen or have significant liver or renal disease

Minimum Eligible Age

6 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No