Bronchiolitis ObliteransPhase 4NCT00367419
Use of Erythromycin in Mustard-Induced Bronchiolitis
A Phase 4 study testing Erythromycin in people with Bronchiolitis Obliterans and Acute Obliterating Bronchiolitis, run by Baqiyatallah Medical Sciences University at 1 site in Iran.
Trial summary
We looked for the effectiveness of low-dose long-term prescription of erythromycin in mustard-induced bronchiolitis obliterans Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Bronchiolitis Obliterans, Acute Obliterating Bronchiolitis
- What is being tested?
- Erythromycin
- How many people
- Not given
- Where
- 1 siteIran
- Study dates
- Start not givento not given
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Iran1 site
Baqiyatallah Medical Sciences University
Tehran, Tehran Province, 19945-546
About this study
Official title: Low-Dose Long-Term Prescription of Erythromycin in Mustard-Induced Bronchiolitis Obliterans
We looked for the effectiveness of low-dose long-term prescription of erythromycin in mustard-induced bronchiolitis obliterans
- Being tested
- Erythromycin
- Medical subject headings
- Bronchiolitis Obliterans
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErythromycinDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2006 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchiolitis ObliteransStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Baqiyatallah Medical Sciences University
- Sponsor type
- University, hospital or other
- Investigators
- Mostafa Ghanei, Professor, Study director, Research Center of Chemical Injuries, Baqyatallah Medical Sciences University, Tehran, Iran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00367419
- Sponsor's protocol ID
- S-340-14-6-1-PU-02
- Status last verified
- Mar 2006
- First submitted
- 21 Aug 2006
- Last updated
- 5 Nov 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-Dose Long-Term Prescription of Erythromycin in Mustard-Induced Bronchiolitis Obliterans
- ClinicalTrials.gov ID
- NCT00367419
- Acronym / sponsor ID
- S-340-14-6-1-PU-02
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Baqiyatallah Medical Sciences UniversityUniversity, hospital or other
- First posted
- 22 Aug 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We looked for the effectiveness of low-dose long-term prescription of erythromycin in mustard-induced bronchiolitis obliterans
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Sex
- Male only
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Erythromycin | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mostafa Ghanei, Professor study director
Research Center of Chemical Injuries, Baqyatallah Medical Sciences University, Tehran, Iran
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Erythromycin in people with Bronchiolitis Obliterans and Acute Obliterating Bronchiolitis, run by Baqiyatallah Medical Sciences University at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2008.