Efficacy and Safety of Azithromycin in Patients With Bronchiolitis Obliterans

NCT05299567 | Completed Phase 4 DMC

• 1 other identifier: 250463
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

Placebo-controlled, double-blind, randomized study. Post-infectious bronchiolitis obliterans (PIBO) patients aged 5 years and older of both sexes were enrolled.

Conditions

Bronchiolitis Obliterans

Keywords

bronchiolitis obliterans; Azithromycin

Outcome Measures

Primary Outcomes (1)

• Percentages change in Forced Expiratory Volume in 1 second (FEV1) Number of Pulmonary exacerbation

  1. FEV1 in percentages 2. Pulmonary exacerbation in numbers

  6 months

Study Arms (2)

azitrhomycin

ACTIVE COMPARATOR

Group1 Azitrhomycin 250 or 500 mg in capsuls tree days a week for 6 months if the patiens are less or more than 40 kg respectively Exposure

Drug: Azithromycin

Placebo

PLACEBO COMPARATOR

Group 2 placebo Not exposure Placebo in capsuls tree days a week for 6 months

Drug: Azithromycin

Interventions

Azithromycin DRUG

Placebo with the same color and size than azithromycin tree days a wek for 6 months

Also known as: placebo

Placebo; azitrhomycin

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients with diagnosis of Bronchiolitis obliternas
• older than 5 years
• Ability to perform pulmonary function test

You may not qualify if:

• Not being able to perform lung function study adequately
• Other causes of chronic lung disease (bronchopulmonary dysplasia, cystic fibrosis, primary or secondary immune deficiency)
• Previous history of portal hypertension, liver cirrhosis, splenomegaly or chang in normal values of laboratory at the start of the study.
• History of hypersensitivity to macrolides

Sponsors & Collaborators

• Claudio Castanos: lead

MeSH Terms

Conditions

Bronchiolitis Obliterans

Interventions

Azithromycin

Condition Hierarchy (Ancestors)

Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals

Study Officials

• Claudio m Castaños, MD

  Hospital de Pediatria "juan P. Garrahan"

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Masking Details: Patients were randomly assigned by pharmacy staff in blocks of 4
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Pediatric pulmonology

Model Details: Placebo-controlled, double-blind, randomized study

Study Record Dates

• First Submitted: May 18, 2017
• First Posted: March 29, 2022
• Study Start: August 24, 2010
• Primary Completion: July 21, 2011
• Study Completion: July 21, 2011
• Last Updated: March 29, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share