NCT00381147

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 26, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 27, 2006

Completed
Last Updated

January 7, 2009

Status Verified

September 1, 2006

First QC Date

September 26, 2006

Last Update Submit

January 6, 2009

Conditions

Bronchiolitis ObliteransAcute Obliterating Bronchiolitis

Interventions

ClarithromycinDRUG

Eligibility Criteria

Sexmale
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • His/her own will to participate
  • Documented chemical exposure
  • Clinical, spirometric and radiological findings were compatible with BO on High Resolution Computed Tomography (HRCT)

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baqiyatallah Medical Sciences University

Tehran, Tehran Province, Iran

Location

MeSH Terms

Conditions

Bronchiolitis Obliterans

Interventions

Clarithromycin

Condition Hierarchy (Ancestors)

BronchiolitisBronchitisBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung Diseases

Intervention Hierarchy (Ancestors)

ErythromycinMacrolidesPolyketidesLactonesOrganic Chemicals

Study Officials

  • Mostafa Ghanei, Professor

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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 26, 2006

First Posted

September 27, 2006

Last Updated

January 7, 2009

Record last verified: 2006-09

Locations

IR(1)