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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	19 February 2015
Main ID:	NCT00367419
Date of registration:	21/08/2006
Prospective Registration:	Yes
Primary sponsor:	Baqiyatallah Medical Sciences University
Public title:	Use of Erythromycin in Mustard-Induced Bronchiolitis
Scientific title:	Low-Dose Long-Term Prescription of Erythromycin in Mustard-Induced Bronchiolitis Obliterans
Date of first enrolment:	November 2006
Target sample size:
Recruitment status:	Completed
URL:	http://clinicaltrials.gov/show/NCT00367419
Study type:	Interventional
Study design:	Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Phase:	Phase 4

Countries of recruitment
Iran, Islamic Republic of

Contacts

Name:	Mostafa Ghanei, Professor
Address:
Telephone:
Email:
Affiliation:	Research Center of Chemical Injuries, Baqyatallah Medical Sciences University, Tehran, Iran

Key inclusion & exclusion 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

Age minimum: N/A
Age maximum: N/A
Gender: Male

Health Condition(s) or Problem(s) studied

Acute Obliterating Bronchiolitis

Bronchiolitis Obliterans

Intervention(s)

Drug: Erythromycin

Primary Outcome(s)

Secondary Outcome(s)

Secondary ID(s)

S-340-14-6-1-PU-02

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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