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

Not Applicable

Completed

• Conditions: Bronchiectasis
• Interventions: Drug: Azithromycin

• Registration Number: NCT01463371
• Lead Sponsor: Instituto de Investigacion Sanitaria La Fe

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

Study Timeline

• Study Start: 2006-10
• Primary Completion: 2007-04
• Study Completion: 2007-09
• Status Verified: 2011-10
• Study First Submitted: 2011-10-28
• Study First Submitted QC: 2011-10-31
• Study First Posted: 2011-11-01
• Last Update Submitted: 2023-09-27
• Last Update Posted: 2023-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
azithromycin	Azithromycin	treatment with azithromycin during three months

Primary Outcome Measures

Name	Time	Method
Changes in Nitric oxide,8-isoprostane, pH, nitrites (NO2) and nitrates(NO3) in exhaled breath condensate.	Before and after three months of treatment	Oxidative stress and NO metabolism in airway were investigated by measuring pH and the concentration of 8-isoprostane, nitrites (NO2-) and nitrates (NO3-) in EBC. Exhaled NO was also determined in all patients.

Secondary Outcome Measures

Name	Time	Method
colour and volume sputum,	Before and after three months of treatment	In order to analyze sputum characteristics, three sterile containers were given to collect all sputum produced during three consecutive days. The average of the three days was calculated and expressed in mL/day. Sputum colour was scored using a scale developed and validated in our laboratory, which ranged from zero to fifteen: transparent (0), white (1), progressive intensities of yellow (2-7), green (8-10) and brown (10-15). Colour scores were decided after agreement between two investigators
Impact on functional capacity and health related quality of life	Before and after three months of treatment	The impact on functional capacity and patient´s daily life was evaluated with the Medical Research Council Dyspnea scale (MRC) and the Spanish version of the Saint George's respiratory questionnaire of quality of life (SGRQ)
Number of Exacerbations	Before and after three months of treatment	exacerbations was defined by hospital admissions or antibiotics prescription
changes in lung function	Before and after three months of treatment	Changes in FEV1, FVC.
Changes in HRCT Lung scores	Before and after three months of treatment	Standard lung HRCT scan was performed to quantify the extension of bronchiectasis

Trial Locations

Locations (1)

University Hospital La Fe; 🇪🇸 Valencia, Spain