Chronic Obstructive Pulmonary DiseasePhase 3NCT00515606
Noninvasive Positive Pressure Ventilation Using Helium:Oxygen Versus Air:Oxygen in Acute Respiratory Failure in Chronic Obstructive Pulmonary Disease Patients Exposed to Sulfur Mustard
A Phase 3 study testing helium:oxygen in people with Chronic Obstructive Pulmonary Disease and Bronchiolitis, run by Baqiyatallah Medical Sciences University.
Trial summary
to assess the effectiveness of helium:oxygen mixture adjunct with non-invasive ventilation in sulfur mustard exposed patients with acute decompensation Read more about this study
- Who is it for?
- Ages 38 to 59 years, men only
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Bronchiolitis
- What is being tested?
- helium:oxygen
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Feb 2007to Jun 2007
- 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 38 to 59 years
- Men only
- Adult
Who may be able to join
- a history of previous exposure to sulfur mustard
- worsening dyspnea during the last 10 days
- respiratory rate >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 NIV
About this study
to assess the effectiveness of helium:oxygen mixture adjunct with non-invasive ventilation in sulfur mustard exposed patients with acute decompensation
- Being tested
- helium:oxygen
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Bronchiolitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
helium:oxygenDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
assess spirometry and hemodynamic measures after heliox or air:oxygen use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2007 (estimated)
- Study startFeb 2007
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
Sponsor and investigators
- Lead sponsor
- Baqiyatallah Medical Sciences University
- Sponsor type
- University, hospital or other
- Investigators
- Mostafa Ghanei, MD, Study director, Research Center of Chemical Injuries, Baqiyatallah Medical Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00515606
- Sponsor's protocol ID
- 210586
- Status last verified
- Feb 2007
- First submitted
- 13 Aug 2007
- Last updated
- 14 Aug 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninvasive Positive Pressure Ventilation Using Helium:Oxygen Versus Air:Oxygen in Acute Respiratory Failure in Chronic Obstructive Pulmonary Disease Patients Exposed to Sulfur Mustard
- ClinicalTrials.gov ID
- NCT00515606
- Acronym / sponsor ID
- 210586
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Baqiyatallah Medical Sciences UniversityUniversity, hospital or other
- Study start
- Feb 2007
- Study completion
- Jun 2007
- First posted
- 14 Aug 2007 (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 effectiveness of helium:oxygen mixture adjunct with non-invasive ventilation in sulfur mustard exposed patients with acute decompensation
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
Who may qualify
- Ages
- 38 to 59 years
- Sex
- Male only
- Age groups
- Adult
Key inclusion criteria (6 listed)
- a history of previous exposure to sulfur mustard
- worsening dyspnea during the last 10 days
- respiratory rate >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 NIV
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 | Drug | – |
Primary outcome
assess spirometry and hemodynamic measures after heliox or air:oxygen use
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 14 Aug 2007.
Related trials for Chronic Obstructive Pulmonary Disease
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease
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, MD study director
Research Center of Chemical Injuries, Baqiyatallah Medical Sciences University
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing helium:oxygen in people with Chronic Obstructive Pulmonary Disease and Bronchiolitis, run by Baqiyatallah Medical Sciences University.
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 14 Aug 2007. Status can change between updates, so confirm with the study contact before making plans.
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.
What does the primary outcome measure?
assess spirometry and hemodynamic measures after heliox or air:oxygen use. It is what the study was designed to measure, not a finding.
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 14 Aug 2007.