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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 Summary

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

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05299567
Study type Interventional
Source Hospital JP Garrahan
Contact
Status Completed
Phase Phase 4
Start date August 24, 2010
Completion date July 21, 2011
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