Use of Erythromycin in Mustard-Induced Bronchiolitis

Sponsor
Baqiyatallah Medical Sciences University (Other)
Overall Status
Completed
CT.gov ID
NCT00367419
Collaborator
(none)
1

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Double
Primary Purpose:
Treatment
Official Title:
Low-Dose Long-Term Prescription of Erythromycin in Mustard-Induced Bronchiolitis Obliterans

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Male
    Inclusion Criteria:
    • 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

    Exclusion Criteria:
    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Baqiyatallah Medical Sciences University Tehran Iran, Islamic Republic of 19945-546

    Sponsors and Collaborators

    • Baqiyatallah Medical Sciences University

    Investigators

    • Study Director: Mostafa Ghanei, Professor, Research Center of Chemical Injuries, Baqyatallah Medical Sciences University, Tehran, Iran

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00367419
    Other Study ID Numbers:
    • S-340-14-6-1-PU-02
    First Posted:
    Aug 22, 2006
    Last Update Posted:
    Nov 5, 2008
    Last Verified:
    Mar 1, 2006

    Study Results

    No Results Posted as of Nov 5, 2008