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

Bronchiectasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01463371
• Other study ID #: 04/2004/0144
• Status: Completed
• Phase: N/A
• Start date: October 2006
• Est. completion date: September 2007

Study information

• Verified date: October 2011
• Source: Instituto de Investigacion Sanitaria La Fe
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2007
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bronchiectasis

Intervention

Drug:
• Azithromycin
250 mg three times a week during three months

Locations

Country	Name	City	State
Spain	University Hospital La Fe	Valencia

Sponsors (2)

Lead Sponsor	Collaborator
Instituto de Investigacion Sanitaria La Fe	Sociedad Valenciana de Neumología

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Nitric oxide,8-isoprostane, pH, nitrites (NO2) and nitrates(NO3) in exhaled breath condensate.	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.	Before and after three months of treatment
Secondary	Number of Exacerbations	exacerbations was defined by hospital admissions or antibiotics prescription	Before and after three months of treatment
Secondary	changes in lung function	Changes in FEV1, FVC.	Before and after three months of treatment
Secondary	colour and volume sputum,	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	Before and after three months of treatment
Secondary	Impact on functional capacity and health related quality of life	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)	Before and after three months of treatment
Secondary	Changes in HRCT Lung scores	Standard lung HRCT scan was performed to quantify the extension of bronchiectasis	Before and after three months of treatment