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

Instituto de Investigacion Sanitaria La Fe

Status: Completed

Conditions: Bronchiectasis

Treatments: Drug: Azithromycin

Study type: Interventional

Funder types: Other

Identifiers

NCT01463371

04/2004/0144

Details and patient eligibility

About

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.

Full 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

Enrollment: 30 patients

Sex: All

Ages: 16 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Control

No Intervention group

Description:

without azithromycin

azithromycin

Active Comparator group

Description:

treatment with azithromycin during three months

Treatment:

Drug: Azithromycin