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Use of Clarithromycin in Mustard-Induced Bronchiolitis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00381147
First Posted: September 27, 2006
Last Update Posted: January 7, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Baqiyatallah Medical Sciences University
  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
Intervention Model: Parallel Assignment
Masking: Double
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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00381147     History of Changes
Other Study ID Numbers: S-340-14-6-1-PU-11
First Submitted: September 26, 2006
First Posted: September 27, 2006
Last Update Posted: January 7, 2009
Last Verified: September 2006

Additional relevant MeSH terms:
Bronchiolitis
Bronchiolitis Obliterans
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Clarithromycin
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors