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

Primary Purpose

Bronchiectasis

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Azithromycin
Sponsored by
Instituto de Investigacion Sanitaria La Fe
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Bronchiectasis focused on measuring Bronchiectasis, Oxidative stress markers, Airway inflammation

Eligibility Criteria

16 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University Hospital La Fe

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Control

azithromycin

Arm Description

without azithromycin

treatment with azithromycin during three months

Outcomes

Primary Outcome Measures

Changes in Nitric oxide,8-isoprostane, pH, nitrites (NO2) and nitrates(NO3) in exhaled breath condensate.
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
exacerbations was defined by hospital admissions or antibiotics prescription
changes in lung function
Changes in FEV1, FVC.
colour and volume sputum,
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
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
Standard lung HRCT scan was performed to quantify the extension of bronchiectasis

Full Information

First Posted
October 28, 2011
Last Updated
September 27, 2023
Sponsor
Instituto de Investigacion Sanitaria La Fe
Collaborators
Sociedad Valenciana de Neumología
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1. Study Identification

Unique Protocol Identification Number
NCT01463371
Brief Title
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

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
September 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto de Investigacion Sanitaria La Fe
Collaborators
Sociedad Valenciana de Neumología

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiectasis
Keywords
Bronchiectasis, Oxidative stress markers, Airway inflammation

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
without azithromycin
Arm Title
azithromycin
Arm Type
Active Comparator
Arm Description
treatment with azithromycin during three months
Intervention Type
Drug
Intervention Name(s)
Azithromycin
Other Intervention Name(s)
Before treatment or after treatment
Intervention Description
250 mg three times a week during three months
Primary Outcome Measure Information:
Title
Changes in Nitric oxide,8-isoprostane, pH, nitrites (NO2) and nitrates(NO3) in exhaled breath condensate.
Description
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.
Time Frame
Before and after three months of treatment
Secondary Outcome Measure Information:
Title
Number of Exacerbations
Description
exacerbations was defined by hospital admissions or antibiotics prescription
Time Frame
Before and after three months of treatment
Title
changes in lung function
Description
Changes in FEV1, FVC.
Time Frame
Before and after three months of treatment
Title
colour and volume sputum,
Description
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
Time Frame
Before and after three months of treatment
Title
Impact on functional capacity and health related quality of life
Description
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)
Time Frame
Before and after three months of treatment
Title
Changes in HRCT Lung scores
Description
Standard lung HRCT scan was performed to quantify the extension of bronchiectasis
Time Frame
Before and after three months of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alfredo De Diego Damia, MD
Organizational Affiliation
Instituto Investigación Sanitaria La Fe
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain

12. IPD Sharing Statement

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

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