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Use of Clarithromycin in Mustard-Induced Bronchiolitis

Primary Purpose

Bronchiolitis Obliterans, Acute Obliterating Bronchiolitis

Status

Completed

Phase

Phase 3

Locations

Iran, Islamic Republic of

Study Type

Interventional

Intervention

Clarithromycin

About this trial

This is an interventional treatment trial for Bronchiolitis Obliterans

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

Sites / Locations

Baqiyatallah Medical Sciences University

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00381147

First Posted

September 26, 2006

Last Updated

January 6, 2009

Sponsor

Baqiyatallah Medical Sciences University

1. Study Identification

Unique Protocol Identification Number

NCT00381147

Brief Title

Use of Clarithromycin in Mustard-Induced Bronchiolitis

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2006

Overall Recruitment Status

Completed

Study Start Date

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Primary Completion Date

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Study Completion Date

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3. Sponsor/Collaborators

Name of the Sponsor

Baqiyatallah Medical Sciences University

4. Oversight

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bronchiolitis Obliterans, Acute Obliterating Bronchiolitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Clarithromycin

10. Eligibility

Sex

Male

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mostafa Ghanei, Professor

Organizational Affiliation

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

Official's Role

Study Director

Facility Information:

Facility Name

Baqiyatallah Medical Sciences University

City

Tehran

Country

Iran, Islamic Republic of

12. IPD Sharing Statement

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Use of Clarithromycin in Mustard-Induced Bronchiolitis

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