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.

Study Overview

• Status: Completed
• Conditions: Bronchiectasis
• Intervention / Treatment: Drug: Azithromycin

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

Study Locations

• Spain
  • Valencia, Spain, 46026
    • University Hospital La Fe

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; without azithromycin	Drug: Azithromycin; 250 mg three times a week during three months; Other Names: Before treatment or after treatment
Active Comparator: azithromycin; treatment with azithromycin during three months	Drug: Azithromycin; 250 mg three times a week during three months; Other Names: Before treatment or after treatment

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.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Exacerbations	exacerbations was defined by hospital admissions or antibiotics prescription	Before and after three months of treatment
changes in lung function	Changes in FEV1, FVC.	Before and after three months of treatment
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	Before and after three months of treatment
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)	Before and after three months of treatment
Changes in HRCT Lung scores	Standard lung HRCT scan was performed to quantify the extension of bronchiectasis	Before and after three months of treatment

Collaborators and Investigators

• Sponsor: Instituto de Investigacion Sanitaria La Fe
• Collaborators: Sociedad Valenciana de Neumología
• Investigators: Principal Investigator: Alfredo De Diego Damia, MD, Instituto Investigación Sanitaria La Fe

Study record dates

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

• Keywords: Bronchiectasis; Oxidative stress markers; Airway inflammation
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Bronchial Diseases; Bronchiectasis; Anti-Infective Agents; Anti-Bacterial Agents; Azithromycin
• 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