Efficacy and Safety of Azithromycin in Patients With Bronchiolitis Obliterans

Claudio Castanos

Status and phase: Completed; Phase 4

Conditions: Bronchiolitis Obliterans

Treatments: Drug: Azithromycin

Study type: Interventional

Funder types: Other

Identifiers

NCT05299567

250463

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 5 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups, including a placebo group

azitrhomycin

Active Comparator group

Description:

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

Treatment:

Drug: Azithromycin

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Azithromycin