BronchiolitisPhase 2/3NCT00642447
Helium:Oxygen Noninvasive Positive Pressure Ventilation in Patients Exposed to Sulfur Mustard
A Phase 2/3 study testing helium:oxygen mixture in people with Bronchiolitis and Chronic Bronchitis, run by Baqiyatallah Medical Sciences University at 1 site in Iran.
Trial summary
to assess the effect of Heliox with Noninvasive positive pressure ventilation to decrease dyspnea and improve physiologic and respiratory measures in patients with a previous exposure to Sulfur Mustard gas. Read more about this study
- Who is it for?
- Ages 38 to 59 years, men only
- Conditions the study is for
- Bronchiolitis, Chronic Bronchitis
- What is being tested?
- helium:oxygen mixture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteIran
- Study dates
- Apr 2007to not given
- Phase
- Phase 2/3
- 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 38 to 59 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- exposure to sulfur mustard
- worsening dyspnea during the last 10 days
- respiratory rate of >25/min
- arterial pH<7.35
- PaCO2 of >50 mmHg
- PaO2 of <50 mmHg
Who cannot join
- recent pneumothorax (<1 month)
- severe respiratory failure or hemodynamic instability with forthcoming intubation
- FIO2 of <0.4
- impaired consciousness or absence of patient cooperation
- facial lesions precluding NIPPV
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Helium:Oxygen Versus Air:Oxygen Nonivasive Positive Pressure Ventilation in Patients Exposed to Sulfur Mustard
to assess the effect of Heliox with Noninvasive positive pressure ventilation to decrease dyspnea and improve physiologic and respiratory measures in patients with a previous exposure to Sulfur Mustard gas.
- Conditions
- Bronchiolitis, Chronic Bronchitis
- Being tested
- helium:oxygen mixture
- Keywords
- noninvasive ventilation, helium, oxygen, sulfur mustard, chronic bronchitis, bronchiolitis
- Medical subject headings
- Bronchiolitis, Bronchitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
helium:oxygen mixtureDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: helium:oxygen mixture |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2008 (estimated)
- Study startApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BronchiolitisStudies 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 2/3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 23 participants
Sponsor and investigators
- Lead sponsor
- Baqiyatallah Medical Sciences University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00642447
- Sponsor's protocol ID
- B12406
- Status last verified
- Mar 2008
- First submitted
- 19 Mar 2008
- Last updated
- 25 Mar 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Helium:Oxygen Versus Air:Oxygen Nonivasive Positive Pressure Ventilation in Patients Exposed to Sulfur Mustard
- ClinicalTrials.gov ID
- NCT00642447
- Acronym / sponsor ID
- B12406
- Conditions
- Bronchiolitis, Chronic Bronchitis
- Keywords
- noninvasive ventilation, helium, oxygen, sulfur mustard, chronic bronchitis, bronchiolitis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants
- Lead sponsor
- Baqiyatallah Medical Sciences UniversityUniversity, hospital or other
- Study start
- Apr 2007
- First posted
- 25 Mar 2008 (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.
to assess the effect of Heliox with Noninvasive positive pressure ventilation to decrease dyspnea and improve physiologic and respiratory measures in patients with a previous exposure to Sulfur Mustard gas.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: helium:oxygen mixture |
Who may qualify
- Ages
- 38 to 59 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- exposure to sulfur mustard
- worsening dyspnea during the last 10 days
- respiratory rate of >25/min
- arterial pH<7.35
- PaCO2 of >50 mmHg
Key exclusion criteria (5 listed)
- recent pneumothorax (<1 month)
- severe respiratory failure or hemodynamic instability with forthcoming intubation
- FIO2 of <0.4
- impaired consciousness or absence of patient cooperation
- facial lesions precluding NIPPV
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 |
|---|---|---|
| helium:oxygen mixture | Drug | 1 |
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 25 Mar 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing helium:oxygen mixture in people with Bronchiolitis and Chronic Bronchitis, 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 6 inclusion and 5 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 25 Mar 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 25 Mar 2008.