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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

October 28, 2011
October 31, 2011
October 2006
April 2007   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01463371 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Effects of Azithromycin on Airway Oxidative Stress Markers in Patients With Bronchiectasis
Effects of Long-Term Azithromycin Treatment on Airway Oxidative Stress Markers in Patients With Stable Non-Cystic Fibrosis Bronchiectasis

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.

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

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Bronchiectasis
Drug: Azithromycin
250 mg three times a week during three months
Other Name: Before treatment or after treatment
  • No Intervention: Control
    without azithromycin
    Intervention: Drug: Azithromycin
  • Active Comparator: azithromycin
    treatment with azithromycin during three months
    Intervention: Drug: Azithromycin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
September 2007
April 2007   (final data collection date for primary outcome measure)

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.
Both
16 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01463371
04/2004/0144
Yes
Instituto de Investigacion Sanitaria La Fe
Instituto de Investigacion Sanitaria La Fe
Sociedad Valenciana de Neumología
Principal Investigator: Alfredo De Diego Damia, MD Instituto Investigación Sanitaria La Fe
Instituto de Investigacion Sanitaria La Fe
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP