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

NCT ID: NCT01463371

Last Updated: 2023-09-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2007-09-30

Brief 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

Bronchiectasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Control

without azithromycin

Group Type: NO_INTERVENTION

No interventions assigned to this group

azithromycin

treatment with azithromycin during three months

Group Type: ACTIVE_COMPARATOR

Azithromycin

Intervention Type: DRUG

250 mg three times a week during three months

Interventions

Azithromycin

250 mg three times a week during three months

Intervention Type: DRUG

Other Intervention Names

Before treatment or after treatment

Eligibility Criteria

Inclusion Criteria

• Previous diagnosis of bronchiectasis based on lung HRCT and clinical symptoms
• Clinically stable in previous four weeks without exacerbations
• Informed consent

Exclusion Criteria

• Bronchiectasis secondary to Cystic fibrosis, pulmonary surgical processes, immune deficiency, emphysema, allergic bronchopulmonary aspergillosis or diffuse interstitial pulmonary diseases
• Intolerance to macrolides or severe liver disease.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sociedad Valenciana de Neumología

UNKNOWN

Sponsor Role: collaborator

Instituto de Investigacion Sanitaria La Fe

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alfredo De Diego Damia, MD

Role: PRINCIPAL_INVESTIGATOR

Instituto Investigación Sanitaria La Fe

Locations

University Hospital La Fe

Valencia, , Spain

Countries

Spain

Other Identifiers

04/2004/0144

Identifier Type: -

Identifier Source: org_study_id