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

This study has been completed.
Sponsor:
Collaborator:
Sociedad Valenciana de Neumología
Information provided by (Responsible Party):
Instituto de Investigacion Sanitaria La Fe
ClinicalTrials.gov Identifier:
NCT01463371
First received: October 28, 2011
Last updated: October 31, 2011
Last verified: October 2011
History of Changes
  Purpose

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 Intervention
Bronchiectasis
 Drug: Azithromycin

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Instituto de Investigacion Sanitaria La Fe:

Primary Outcome Measures:
  • Changes in Nitric oxide,8-isoprostane, pH, nitrites (NO2) and nitrates(NO3) in exhaled breath condensate. [ Time Frame: Before and after three months of treatment ] [ Designated as safety issue: No ]
    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:
  • Number of Exacerbations [ Time Frame: Before and after three months of treatment ] [ Designated as safety issue: No ]
    exacerbations was defined by hospital admissions or antibiotics prescription

  • changes in lung function [ Time Frame: Before and after three months of treatment ] [ Designated as safety issue: No ]
    Changes in FEV1, FVC.

  • colour and volume sputum, [ Time Frame: Before and after three months of treatment ] [ Designated as safety issue: No ]
    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 [ Time Frame: Before and after three months of treatment ] [ Designated as safety issue: No ]
    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)

  • Changes in HRCT Lung scores [ Time Frame: Before and after three months of treatment ] [ Designated as safety issue: No ]
    Standard lung HRCT scan was performed to quantify the extension of bronchiectasis


Enrollment: 30
Study Start Date: October 2006
Study Completion Date: September 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
without azithromycin
 Drug: Azithromycin
250 mg three times a week during three months
Other Name: 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 Name: Before treatment or after treatment

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

Ages Eligible for Study:   16 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01463371

Locations
Spain
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
  More Information

No publications provided

Responsible Party: Instituto de Investigacion Sanitaria La Fe
ClinicalTrials.gov Identifier: NCT01463371     History of Changes
Other Study ID Numbers: 04/2004/0144
Study First Received: October 28, 2011
Last Updated: October 31, 2011
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Instituto de Investigacion Sanitaria La Fe:
Bronchiectasis
Oxidative stress markers
Airway inflammation

Additional relevant MeSH terms:
Bronchiectasis
Bronchial Diseases
Respiratory Tract Diseases
Azithromycin
 Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013