Use of Clarithromycin in Mustard-Induced Bronchiolitis

Bronchiolitis Obliterans Clinical Trial

Official title:

Phase III, Randomized, Double Blind Study of Low Dose Long Term Clarithromycin Versus Placebo in Treatment of Chronic Pulmonary Lesions Due to Sulfur Mustard

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00381147
• Other study ID #: S-340-14-6-1-PU-11
• Status: Completed
• Phase: Phase 3
• First received: September 26, 2006
• Last updated: January 6, 2009

Study information

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

Clinical Trial Summary

We looked for the effectiveness of low-dose long-term prescription of clarithromycin in mustard-induced chronic pulmonary lesions, especially bronchiolitis obliterans

Recruitment information / eligibility

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

Eligibility

Inclusion Criteria:

• His/her own will to participate

• Documented chemical exposure

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

Exclusion Criteria:

• any drug reactions during the trial

• history of sensitivity to macrolides

• diarrhea, gray stool, jaundice, eosinophilia, acute cholestatic hepatitis, pruritis, dark urine, abdominal pain, osteomatosis, depression, taste change, behavioural changes, early fatigue, odynophagia, glossitis , dizziness

• co-adminstration of: terfenadine, theophylline, carbamazepine, ergotamine, dihydroergotamine, warfarin, cisapride, digoxin, triazolam, phenytoin, steroids, any immunosuppressive, any systemic antibiotics

• using drugs that he/she cannot discontinue

• using drugs with potential interaction

• subject will to exit from the trial

• history of lobe resection of lung

• history of exacerbation in the last month prior to the beginning of trial

• continuous need to oxygen

• use of corticosteroids in last week prior to the trial beginning

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

• exacerbating of subjects

• creatinine srum level more than normal

• increasing ALT, AST levels

• total bilirubin more twice than normal

• subjects who did not use their drugs properly

Study Design

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

Related Conditions & MeSH terms

• Acute Obliterating Bronchiolitis
• Bronchiolitis
• Bronchiolitis Obliterans

Intervention

Drug:
• Clarithromycin

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,