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

• Sponsor: Instituto de Investigacion Sanitaria La Fe (Other)
• Overall Status: Completed
• CT.gov ID: NCT01463371
• Collaborator: Sociedad Valenciana de Neumología (Other)
• Enrollment: 30
• Location: 1
• Arms: 2
• Duration (Months): 11
• Patients Per Site Per Month: 2.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bronchiectasis	Drug: Azithromycin	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Effects of Long-Term Azithromycin Treatment on Airway Oxidative Stress Markers in Patients With Stable Non-Cystic Fibrosis Bronchiectasis
• Study Start Date: Oct 1, 2006
• Actual Primary Completion Date: Apr 1, 2007
• Actual Study Completion Date: Sep 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control without azithromycin	Drug: Azithromycin; 250 mg three times a week during three months; Other Names: Before treatment or after treatment
Active Comparator: azithromycin treatment with azithromycin during three months	Drug: Azithromycin; 250 mg three times a week during three months; Other Names: Before treatment or after treatment

Outcome Measures

Primary Outcome Measures

1. 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

1. Number of Exacerbations [Before and after three months of treatment]

   exacerbations was defined by hospital admissions or antibiotics prescription

2. changes in lung function [Before and after three months of treatment]

   Changes in FEV1, FVC.

3. 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

4. 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)

5. Changes in HRCT Lung scores [Before and after three months of treatment]

   Standard lung HRCT scan was performed to quantify the extension of bronchiectasis

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital La Fe	Valencia		Spain	46026

Sponsors and Collaborators

• Instituto de Investigacion Sanitaria La Fe
• Sociedad Valenciana de Neumología

Investigators

• Principal Investigator: Alfredo De Diego Damia, MD, Instituto Investigación Sanitaria La Fe

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Instituto de Investigacion Sanitaria La Fe
• ClinicalTrials.gov Identifier: NCT01463371
• Other Study ID Numbers: 04/2004/0144
• First Posted: Nov 1, 2011
• Last Update Posted: Nov 1, 2011
• Last Verified: Oct 1, 2011

• Keywords provided by Instituto de Investigacion Sanitaria La Fe: Bronchiectasis; Oxidative stress markers; Airway inflammation
• Additional relevant MeSH terms: Bronchiectasis; Azithromycin

Study Results

No Results Posted as of Nov 1, 2011