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

NCT01463371 | Completed DMC

• 1 other identifier: 04/2004/0144
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Bronchiectasis

Keywords

Bronchiectasis; Oxidative stress markers; Airway inflammation

Outcome Measures

Primary Outcomes (1)

• 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.

  Before and after three months of treatment

Secondary Outcomes (5)

• Number of Exacerbations

  Before and after three months of treatment

• changes in lung function

  Before and after three months of treatment

• colour and volume sputum,

  Before and after three months of treatment

• Impact on functional capacity and health related quality of life

  Before and after three months of treatment

• Changes in HRCT Lung scores

  Before and after three months of treatment

Study Arms (2)

Control

NO INTERVENTION

without azithromycin

azithromycin

ACTIVE COMPARATOR

treatment with azithromycin during three months

Drug: Azithromycin

Interventions

Azithromycin DRUG

250 mg three times a week during three months

Also known as: Before treatment or after treatment

azithromycin

Eligibility Criteria

• Age: 16 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Previous diagnosis of bronchiectasis based on lung HRCT and clinical symptoms
• Clinically stable in previous four weeks without exacerbations
• Informed consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto de Investigacion Sanitaria La Fe: lead
• Sociedad Valenciana de Neumología: collaborator

Study Sites (1)

University Hospital La Fe

Valencia, 46026, Spain

Location

MeSH Terms

Conditions

Bronchiectasis

Interventions

Azithromycin; Aftercare

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Primary Health Care; Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Officials

• Alfredo De Diego Damia, MD

  Instituto Investigación Sanitaria La Fe

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2011
• First Posted: November 1, 2011
• Study Start: October 1, 2006
• Primary Completion: April 1, 2007
• Study Completion: September 1, 2007
• Last Updated: September 29, 2023

Record last verified: 2011-10

Locations

ES (1)