Use of Erythromycin in Mustard-Induced Bronchiolitis

Bronchiolitis Obliterans Clinical Trial

Official title:

Low-Dose Long-Term Prescription of Erythromycin in Mustard-Induced Bronchiolitis Obliterans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00367419
• Other study ID #: S-340-14-6-1-PU-02
• Status: Completed
• Phase: Phase 4
• First received: August 21, 2006
• Last updated: November 4, 2008

Study information

• Verified date: March 2006
• Source: Baqiyatallah Medical Sciences University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

We looked for the effectiveness of low-dose long-term prescription of erythromycin in mustard-induced bronchiolitis obliterans

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Gender: Male
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Documented chemical exposure

• Clinical, spirometric and radiological findings were compatible with BO on High Resolution Computed Tomography (HRCT)

• Non-responsiveness to high dose bronchodilator therapy

Exclusion Criteria:

• Radiographic evidence of pneumonia, active tuberculosis, lung carcinoma, or an infection that necessitated the use of an antibiotic

• History of cigarette smoking and occupational exposure to toxic agents of hypersensitivity to macrolides

• History of treatment with a systemic antibiotic within 7 days before the start of the study

• Any investigational medicine within 4 weeks of the study

• History of antibiotic injection within 6 weeks before the study

• Concomitant Theophylline or Carbamazepine, unless their serum concentrations were regularly monitored

• Patients who were in the exacerbation phase of their respiratory complications

• Need to use medications interact with macrolides such as Digoxin, Theophylline and Carbamazepine

• Systemic antibiotics

• Systemic Corticosteroids

• Admission to the hospital

• Abnormal kidney or liver function

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Obliterating Bronchiolitis
• Bronchiolitis
• Bronchiolitis Obliterans

Intervention

Drug:
• Erythromycin

Locations

Country	Name	City	State
Iran, Islamic Republic of	Baqiyatallah Medical Sciences University	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Baqiyatallah Medical Sciences University

Country where clinical trial is conducted

Iran, Islamic Republic of,