- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01463371
Effects of Azithromycin on Airway Oxidative Stress Markers in Patients With Bronchiectasis
September 27, 2023 updated by: Instituto de Investigacion Sanitaria La Fe
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.
Study Overview
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
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Valencia, Spain, 46026
- University Hospital La Fe
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 80 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
without azithromycin
|
250 mg three times a week during three months
Other Names:
|
Active Comparator: azithromycin
treatment with azithromycin during three months
|
250 mg three times a week during three months
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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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.
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Before and after three months of treatment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Exacerbations
Time Frame: Before and after three months of treatment
|
exacerbations was defined by hospital admissions or antibiotics prescription
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Before and after three months of treatment
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changes in lung function
Time Frame: Before and after three months of treatment
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Changes in FEV1, FVC.
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Before and after three months of treatment
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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
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Before and after three months of treatment
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Impact on functional capacity and health related quality of life
Time Frame: Before and after three months of treatment
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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)
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Before and after three months of treatment
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Changes in HRCT Lung scores
Time Frame: Before and after three months of treatment
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Standard lung HRCT scan was performed to quantify the extension of bronchiectasis
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Before and after three months of treatment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Alfredo De Diego Damia, MD, Instituto Investigación Sanitaria La Fe
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2006
Primary Completion (Actual)
April 1, 2007
Study Completion (Actual)
September 1, 2007
Study Registration Dates
First Submitted
October 28, 2011
First Submitted That Met QC Criteria
October 31, 2011
First Posted (Estimated)
November 1, 2011
Study Record Updates
Last Update Posted (Actual)
September 29, 2023
Last Update Submitted That Met QC Criteria
September 27, 2023
Last Verified
October 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 04/2004/0144
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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