Clinical Trials Directory

Trials / Completed

CompletedNCT01463371

Effects of Azithromycin on Airway Oxidative Stress Markers in Patients With Bronchiectasis

Effects of Long-Term Azithromycin Treatment on Airway Oxidative Stress Markers in Patients With Stable Non-Cystic Fibrosis Bronchiectasis

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
30 (actual)
Sponsor
Instituto de Investigacion Sanitaria La Fe · Academic / Other
Sex
All
Age
16 Years – 80 Years
Healthy volunteers
Not accepted

Summary

The mechanism by which macrolide antibiotics have immune modifying effects independent from its antibacterial activity has not been well established. In the present work, the investigators will analyze the effect of long-term treatment with azithromycin (250 mg three times per week during three months) on airway oxidative stress markers in exhaled breath condensate of adult patients with stable non-CF bronchiectasis.

Detailed description

The mechanism by which macrolide antibiotics have immune modifying effects independent from its antibacterial activity has not been well established. In the present work, we will analyze the effect of long-term treatment with azithromycin (AZ) on airway oxidative stress markers in exhaled breath condensate of adult patients with stable non-CF bronchiectasis. Patients will be randomized in an open label model to receive AZ 250 mg three times per week during three months or nothing.Dyspnea (Borg scale), exacerbations (Nº) in the last three months, sputum volume (cc), sputum colour (15-point scale), and health related quality of life (Questionnaire St.George) will be measured in both groups before and after treatment. Lung function, sputum culture, CT scan (Bhalla score) and inflammatory markers in blood (ESR, PCR),exhaled air (Nitric Oxide,) and exhaled condensed air (pH, nitrites, isoprostane) will be assessed before and after treatment. Relationships between clinical and inflammatory markers will be studied

Conditions

Interventions

TypeNameDescription
DRUGAzithromycin250 mg three times a week during three months

Timeline

Start date
2006-10-01
Primary completion
2007-04-01
Completion
2007-09-01
First posted
2011-11-01
Last updated
2023-09-29

Locations

1 site across 1 country: Spain

Source: ClinicalTrials.gov record NCT01463371. Inclusion in this directory is not an endorsement.