Clinical trial NCT01463371: Effects of Azithromycin on Airway Oxidative Stress Markers in Patients With Bronchiectasis
Official title: Effects of Long-Term Azithromycin Treatment on Airway Oxidative Stress Markers in Patients With Stable Non-Cystic Fibrosis Bronchiectasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bronchiectasis
Keywords: Bronchiectasis
Oxidative stress markers
Airway inflammation
Lead sponsor: Instituto de Investigacion Sanitaria La Fe
Sponsor class: OTHER
Collaborators: name: Sociedad Valenciana de Neumología
First posted: 2011-11-01
Enrollment: 30
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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

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.

Primary outcomes:
measure: Changes in Nitric oxide,8-isoprostane, pH, nitrites (NO2) and nitrates(NO3) in exhaled breath condensate.
timeFrame: Before and after three months of treatment
Secondary outcomes:
measure: Number of Exacerbations
timeFrame: Before and after three months of treatment
measure: changes in lung function
timeFrame: Before and after three months of treatment
measure: colour and volume sputum,
timeFrame: Before and after three months of treatment
measure: Impact on functional capacity and health related quality of life
timeFrame: Before and after three months of treatment
measure: Changes in HRCT Lung scores
timeFrame: Before and after three months of treatment
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: University Hospital La Fe
Study officials:
affiliation: Instituto Investigación Sanitaria La Fe
name: Alfredo De Diego Damia, MD
role: PRINCIPAL_INVESTIGATOR
References: