Use of Clarithromycin in Mustard-Induced Bronchiolitis

NCT ID: NCT00381147

Last Updated: 2009-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Brief Summary

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

Detailed Description

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Conditions

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Bronchiolitis Obliterans Acute Obliterating Bronchiolitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Clarithromycin

Intervention Type DRUG

Eligibility Criteria

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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
Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Baqiyatallah Medical Sciences University

OTHER

Sponsor Role lead

Principal Investigators

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Mostafa Ghanei, Professor

Role: STUDY_DIRECTOR

Research Center of Chemical Injuries, Baqyatallah Medical Sciences University, Tehran, Iran

Locations

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Baqiyatallah Medical Sciences University

Tehran, Tehran Province, Iran

Site Status

Countries

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Iran

Other Identifiers

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S-340-14-6-1-PU-11

Identifier Type: -

Identifier Source: org_study_id

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