Use of Clarithromycin in Mustard-Induced Bronchiolitis

This study has been completed.
Sponsor:
Information provided by:
Baqiyatallah Medical Sciences University
ClinicalTrials.gov Identifier:
NCT00381147
First received: September 26, 2006
Last updated: January 6, 2009
Last verified: September 2006
  Purpose

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:

  Eligibility

Genders Eligible for Study:   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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00381147

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

No publications provided

ClinicalTrials.gov 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
Bronchiolitis Obliterans
Bronchial Diseases
Bronchitis
Lung Diseases
Lung Diseases, Obstructive
Respiratory Tract Diseases
Respiratory Tract Infections
Clarithromycin
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Synthesis Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014