Efficacy and Safety of Azithromycin in Patients With Bronchiolitis Obliterans

Bronchiolitis Obliterans Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05299567
• Other study ID #: 250463
• Status: Completed
• Phase: Phase 4
• Start date: August 24, 2010
• Est. completion date: July 21, 2011

Study information

• Verified date: January 2022
• Source: Hospital JP Garrahan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 21, 2011
• Est. primary completion date: July 21, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Bronchiolitis
• Bronchiolitis Obliterans

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Claudio Castanos

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentages change in Forced Expiratory Volume in 1 second (FEV1) Number of Pulmonary exacerbation	FEV1 in percentages; Pulmonary exacerbation in numbers	6 months