Use of Erythromycin in Mustard-Induced Bronchiolitis

This study has been completed.

First Received: August 21, 2006 Last Updated: November 4, 2008 History of Changes

Sponsor:	Baqiyatallah Medical Sciences University
Information provided by:	Baqiyatallah Medical Sciences University
ClinicalTrials.gov Identifier:	NCT00367419

Purpose

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

Condition	Intervention	Phase
Bronchiolitis Obliterans Acute Obliterating Bronchiolitis	Drug: Erythromycin	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study
Official Title:	Low-Dose Long-Term Prescription of Erythromycin in Mustard-Induced Bronchiolitis Obliterans

Resource links provided by NLM:

Drug Information available for: Mechlorethamine hydrochloride Erythromycin Gluceptate Erythromycin Erythromycin stearate Erythromycin ethylsuccinate Erythromycin estolate

U.S. FDA Resources

Eligibility

Genders Eligible for Study:

Male

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00367419

Locations

Iran, Islamic Republic of
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

More Information

No publications provided

Study ID Numbers:	S-340-14-6-1-PU-02
Study First Received:	August 21, 2006
Last Updated:	November 4, 2008
ClinicalTrials.gov Identifier:	NCT00367419 History of Changes
Health Authority:	Iran: Ethics Commission

Additional relevant MeSH terms:

Erythromycin stearate
Anti-Infective Agents
Lung Diseases, Interstitial
Molecular Mechanisms of Pharmacological Action
Bronchial Diseases
Erythromycin Ethylsuccinate
Bronchiolitis
Gastrointestinal Agents
Enzyme Inhibitors
Erythromycin
Pharmacologic Actions

Bronchiolitis Obliterans
Anti-Bacterial Agents
Protein Synthesis Inhibitors
Lung Diseases, Obstructive
Respiratory Tract Diseases
Respiratory Tract Infections
Erythromycin Estolate
Therapeutic Uses
Lung Diseases
Bronchitis

ClinicalTrials.gov processed this record on February 08, 2010