We looked for the effectiveness of low-dose long-term prescription of erythromycin in mustard-induced bronchiolitis...
Date First Received: August 21, 2006
Last Updated: November 4, 2008
Verified by: Baqiyatallah Medical Sciences University, March 2006
Clinical Trial Phase: Phase 4 | Start Date:
Overall Status: Completed
Brief Summary
Official Title: “Low-Dose Long-Term Prescription of Erythromycin in Mustard-Induced Bronchiolitis Obliterans”
Condition Keyword(s):
Intervention(s):
We looked for the effectiveness of low-dose long-term prescription of erythromycin in mustard-induced bronchiolitis obliterans
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: Erythromycin
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Male
Minimum Age for this Clinical Trial: N/A
Maximum Age for this Clinical Trial: N/A
Clinical Trial Sponsor Information
Lead Sponsor: Baqiyatallah Medical Sciences University
Overall Clinical Trial Officials and Contacts
Mostafa Ghanei, Professor Study Director Research Center of Chemical Injuries, Baqyatallah Medical Sciences University, Tehran, Iran
Additional Information
Information obtained from ClinicalTrials.gov on July 02, 2009
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00367419
Study ID Number: S-340-14-6-1-PU-02
ClinicalTrials.gov Identifier: NCT00367419
Health Authority: Iran: Ethics Commission
Clinical Trials Authorship and Review
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