NCT00367419

Brief Summary

We looked for the effectiveness of low-dose long-term prescription of erythromycin in mustard-induced 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 21, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 22, 2006

Completed
Last Updated

November 5, 2008

Status Verified

March 1, 2006

First QC Date

August 21, 2006

Last Update Submit

November 4, 2008

Conditions

Bronchiolitis ObliteransAcute Obliterating Bronchiolitis

Interventions

ErythromycinDRUG

Eligibility Criteria

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

You may qualify if:

  • Documented chemical exposure
  • Clinical, spirometric and radiological findings were compatible with BO on High Resolution Computed Tomography (HRCT)
  • Non-responsiveness to high dose bronchodilator therapy

You may not qualify if:

  • Radiographic evidence of pneumonia, active tuberculosis, lung carcinoma, or an infection that necessitated the use of an antibiotic
  • History of cigarette smoking and occupational exposure to toxic agents of hypersensitivity to macrolides
  • History of treatment with a systemic antibiotic within 7 days before the start of the study
  • Any investigational medicine within 4 weeks of the study
  • History of antibiotic injection within 6 weeks before the study
  • Concomitant Theophylline or Carbamazepine, unless their serum concentrations were regularly monitored
  • Patients who were in the exacerbation phase of their respiratory complications
  • Need to use medications interact with macrolides such as Digoxin, Theophylline and Carbamazepine
  • Systemic antibiotics
  • Systemic Corticosteroids
  • Admission to the hospital
  • Abnormal kidney or liver function

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baqiyatallah Medical Sciences University

Tehran, Tehran Province, 19945-546, Iran

Location

MeSH Terms

Conditions

Bronchiolitis Obliterans

Interventions

Erythromycin

Condition Hierarchy (Ancestors)

BronchiolitisBronchitisBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung Diseases

Intervention Hierarchy (Ancestors)

MacrolidesPolyketidesLactonesOrganic 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 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 21, 2006

First Posted

August 22, 2006

Last Updated

November 5, 2008

Record last verified: 2006-03

Locations

IR(1)