Efficacy and Safety of Azithromycin in Patients With Bronchiolitis Obliterans

March 18, 2022 updated by: Claudio Castanos

Double-blind Placebo Trial to Determine the Efficacy and Safety of Treatment With Azithromycin for 6 Months in Patients With Post-infectious Bronchiolitis Obliterans

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Bronchiolitis obliterans (BO) was defined as the presence of signs and symptoms of chronic obstructive lung disease: A) previously documented acute lower respiratory infection (ALRI) with persistence of airway obstruction and respiratory signs and symptoms, such as: dyspnea, tachypnea, retractions, persistent cough, increased antero-posterior diameter of the chest, persistent wheezing, crackles, exercise intolerance; B) findings such as: hyperinflation, atelectasis, and mosaic oligohemia on CT scan; and C) persistent obstructive pattern on pulmonary function test.

Patients were randomly assigned by pharmacy staff in blocks of 4 to receive either capsules of azithromycin 250 mg (Group 1) or placebo (Group 2) 3 days a week for 6 months. Patients whose weight was less than 40 kg received 250 mg 3 days a week (Monday, Wednesday, and Friday) and those weighing more than 40 kg received 500 mg in the same scheme, according to randomization to active drug or placebo. Pulmonary function and number of exacerbations were evaluated. Spirometry and plethysmography were performed at baseline and at 6 months. Variables analyzed were Forced vital capacity (FVC),Flow expiratory volume at the first second (FEV1), Total lung capacity (TLC),Residual volumen(RV),especific conductance (sGaw). Patients had been clinically stable over the previous three weeks.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 4

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

5 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: azitrhomycin
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 with the same color and size than azithromycin tree days a wek for 6 months
Other Names:
  • placebo
Placebo Comparator: Placebo
Group 2 placebo Not exposure Placebo in capsuls tree days a week for 6 months
Drug: Azithromycin
Placebo with the same color and size than azithromycin tree days a wek for 6 months
Other Names:
  • placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentages change in Forced Expiratory Volume in 1 second (FEV1) Number of Pulmonary exacerbation
Time Frame: 6 months
  1. FEV1 in percentages
  2. Pulmonary exacerbation in numbers
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Claudio Castanos

Investigators

  • Principal Investigator: Claudio m Castaños, MD, Hospital de Pediatria "juan P. Garrahan"

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

August 24, 2010

Primary Completion (Actual)

July 21, 2011

Study Completion (Actual)

July 21, 2011

Study Registration Dates

First Submitted

May 18, 2017

First Submitted That Met QC Criteria

March 18, 2022

First Posted (Actual)

March 29, 2022

Study Record Updates

Last Update Posted (Actual)

March 29, 2022

Last Update Submitted That Met QC Criteria

March 18, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 250463

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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.

Clinical Trials on Bronchiolitis Obliterans

Clinical Trials on Azithromycin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cameroon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe