Bronchiolitis ObliteransPhase 3NCT00381147
Use of Clarithromycin in Mustard-Induced Bronchiolitis
A Phase 3 study testing Clarithromycin 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 clarithromycin in mustard-induced chronic pulmonary lesions, especially 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?
- Clarithromycin
- How many people
- Not given
- Where
- 1 siteIran
- Study dates
- Start not givento not given
- Phase
- Phase 3
- 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
- His/her own will to participate
- Documented chemical exposure
- Clinical, spirometric and radiological findings were compatible with BO on High Resolution Computed Tomography (HRCT)
Who cannot join
- any drug reactions during the trial
- history of sensitivity to macrolides
- diarrhea, gray stool, jaundice, eosinophilia, acute cholestatic hepatitis, pruritis, dark urine, abdominal pain, osteomatosis, depression, taste change, behavioural changes, early fatigue, odynophagia, glossitis , dizziness
- co-adminstration of: terfenadine, theophylline, carbamazepine, ergotamine, dihydroergotamine, warfarin, cisapride, digoxin, triazolam, phenytoin, steroids, any immunosuppressive, any systemic antibiotics
- using drugs that he/she cannot discontinue
- using drugs with potential interaction
Show all 17Show fewer
- subject will to exit from the trial
- history of lobe resection of lung
- history of exacerbation in the last month prior to the beginning of trial
- continuous need to oxygen
- use of corticosteroids in last week prior to the trial beginning
- Radiographic evidence of pneumonia, active tuberculosis, lung carcinoma, or an infection that necessitated the use of an antibiotic
- exacerbating of subjects
- creatinine srum level more than normal
- increasing ALT, AST levels
- total bilirubin more twice than normal
- subjects who did not use their drugs properly
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase III, Randomized, Double Blind Study of Low Dose Long Term Clarithromycin Versus Placebo in Treatment of Chronic Pulmonary Lesions Due to Sulfur Mustard
We looked for the effectiveness of low-dose long-term prescription of clarithromycin in mustard-induced chronic pulmonary lesions, especially bronchiolitis obliterans
- Being tested
- Clarithromycin
- Medical subject headings
- Bronchiolitis Obliterans
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClarithromycinDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- NCT00381147
- Sponsor's protocol ID
- S-340-14-6-1-PU-11
- Status last verified
- Sep 2006
- First submitted
- 26 Sep 2006
- Last updated
- 7 Jan 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III, Randomized, Double Blind Study of Low Dose Long Term Clarithromycin Versus Placebo in Treatment of Chronic Pulmonary Lesions Due to Sulfur Mustard
- ClinicalTrials.gov ID
- NCT00381147
- Acronym / sponsor ID
- S-340-14-6-1-PU-11
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Baqiyatallah Medical Sciences UniversityUniversity, hospital or other
- First posted
- 27 Sep 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 clarithromycin in mustard-induced chronic pulmonary lesions, especially bronchiolitis obliterans
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Sex
- Male only
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- His/her own will to participate
- Documented chemical exposure
- Clinical, spirometric and radiological findings were compatible with BO on High Resolution Computed Tomography (HRCT)
Key exclusion criteria (17 listed)
- any drug reactions during the trial
- history of sensitivity to macrolides
- diarrhea, gray stool, jaundice, eosinophilia, acute cholestatic hepatitis, pruritis, dark urine, abdominal pain, osteomatosis, depression, taste change, behavioural changes, early fatigue, odynophagia, glossitis , dizziness
- co-adminstration of: terfenadine, theophylline, carbamazepine, ergotamine, dihydroergotamine, warfarin, cisapride, digoxin, triazolam, phenytoin, steroids, any immunosuppressive, any systemic antibiotics
- using drugs that he/she cannot discontinue
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 |
|---|---|---|
| Clarithromycin | 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 7 Jan 2009.
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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 3 study testing Clarithromycin 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 17 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 7 Jan 2009. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 7 Jan 2009.