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Completed

NCT Number: NCT01463371

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

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Key information

Conditions

Bronchiectasis Bronchial Diseases Respiratory Tract Diseases

Age range

16 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital La Fe

Valencia, 46026, Spain

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Azithromycin

Drug

250 mg three times a week during three months

Other names: Before treatment or after treatment

Primary outcomes

  1. 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

    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 outcomes

  1. Number of Exacerbations

    Time frame: Before and after three months of treatment

    exacerbations was defined by hospital admissions or antibiotics prescription

  2. changes in lung function

    Time frame: Before and after three months of treatment

    Changes in FEV1, FVC.

  3. colour and volume sputum,

    Time frame: 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

    Time frame: 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

    Time frame: Before and after three months of treatment

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

Sponsors and collaborators

Lead sponsor

Instituto de Investigacion Sanitaria La Fe

Other

Collaborators

  • Sociedad Valenciana de Neumología

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Nov 1, 2011
Registry last updated
Sep 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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