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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

September 26, 2006
January 6, 2009
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Complete list of historical versions of study NCT00381147 on ClinicalTrials.gov Archive Site
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Use of Clarithromycin in Mustard-Induced Bronchiolitis
Phase III, Randomized, Double Blind Study of Low Dose Long Term Clarithromycin Versus Placebo in Treatment of Chronic Pulmonary Lesions Due to Sulfur Mustard

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

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Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Bronchiolitis Obliterans
  • Acute Obliterating Bronchiolitis
Drug: Clarithromycin
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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
Male
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Contact information is only displayed when the study is recruiting subjects
Iran, Islamic Republic of
 
NCT00381147
S-340-14-6-1-PU-11
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Baqiyatallah Medical Sciences University
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Study Director: Mostafa Ghanei, Professor Research Center of Chemical Injuries, Baqyatallah Medical Sciences University, Tehran, Iran
Baqiyatallah Medical Sciences University
September 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP