Use of Clarithromycin in Mustard-Induced Bronchiolitis

This study has been completed.
Information provided by:
Baqiyatallah Medical Sciences University Identifier:
First received: September 26, 2006
Last updated: January 6, 2009
Last verified: September 2006

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

Condition Intervention Phase
Bronchiolitis Obliterans
Acute Obliterating Bronchiolitis
Drug: Clarithromycin
Phase 3

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

Resource links provided by NLM:

Further study details as provided by Baqiyatallah Medical Sciences University:


Genders Eligible for Study:   Male

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
  Contacts and Locations
Please refer to this study by its identifier: NCT00381147

Iran, Islamic Republic of
Baqiyatallah Medical Sciences University
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Baqiyatallah Medical Sciences University
Study Director: Mostafa Ghanei, Professor Research Center of Chemical Injuries, Baqyatallah Medical Sciences University, Tehran, Iran
  More Information

No publications provided Identifier: NCT00381147     History of Changes
Other Study ID Numbers: S-340-14-6-1-PU-11
Study First Received: September 26, 2006
Last Updated: January 6, 2009
Health Authority: Iran: Ethics Committee

Additional relevant MeSH terms:
Bronchiolitis Obliterans
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses processed this record on April 17, 2014