Use of Clarithromycin in Mustard-Induced Bronchiolitis

Condition(s) targeted: Bronchiolitis Obliterans; Acute Obliterating Bronchiolitis

Intervention: Clarithromycin (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Baqiyatallah Medical Sciences University

Official(s) and/or principal investigator(s):
Mostafa Ghanei, Professor, Study Director, Affiliation: Research Center of Chemical Injuries, Baqyatallah Medical Sciences University, Tehran, Iran

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

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

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Minimum age: N/A. Maximum age: N/A. Gender(s): Male.

Criteria:

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

Baqiyatallah Medical Sciences University, Tehran, Iran, Islamic Republic of

Last updated: November 29, 2006