AsthmaPhase 2NCT01795742
Equivalence of a Human-Powered Nebulizer to an Electric Nebulizer
A Phase 2 study testing Human-Powered Nebulizer in people with Asthma, run by Marquette University at 1 site in El Salvador.
Trial summary
This is an equivalence study comparing an electric nebulizer with a human-powered nebulizer--one that does not need electricity--in the treatment of mild to moderate asthma exacerbations in a regional clinic in San Salvador, El Salvador. Read more about this study
- Who is it for?
- Ages 6 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- Human-Powered Nebulizer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteEl Salvador
- Study dates
- Aug 2012to Oct 2012
- Phase
- Phase 2
- 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 6 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Suffering from Mild or Moderate Asthma symptoms
- Increased respiratory rate, but not over 30 breaths per minute
- Reduced peak expiratory flow rate, but not less than 60% of normal
- Oxygen saturation levels reduced but greater than 90%
Who cannot join
- Any other respiratory condition that would interfere with nebulizer treatment
- If any other medication is being taken at the time
- Pregnant women or women who may think they might be pregnant
- Never taken salbutamol before
Trial locations and contacts
1 site in 1 country.
El Salvador1 site
Hospital Nacional San Bartolo
Ilopango, San Salvador Department
About this study
Official title: Equivalence of a Human-Powered Nebulizer to an Electric Nebulizer in the Treatment of Mild to Moderate Asthma in El Salvador
This is an equivalence study comparing an electric nebulizer with a human-powered nebulizer--one that does not need electricity--in the treatment of mild to moderate asthma exacerbations in a regional clinic in San Salvador, El Salvador.
Read the detailed description
The study design is to treat individuals suffering from mild to moderate exacerbations of asthma with nebulized salbutamol (2.5mg). Subjects will receive nebulization using either an electric nebulizer compressor or a human-powered nebulizer compressor. Improvement in peak expiratory flow will be the primary endpoint. Blood oxygenation levels as measured by pulse oximetry will be a secondary endpoint of the trial.
- Conditions
- Asthma
- Being tested
- Human-Powered Nebulizer
- Keywords
- Asthma, Nebulizers, Salbutamol, Developing Countries
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human-Powered NebulizerDevice
| Study group | Role | What they receive |
|---|---|---|
| Electric Nebulizer | Active comparator | Pulmo-Aide Model 5650D Receives: Device: Human-Powered Nebulizer |
| Human-Powered Nebulizer | Experimental | Human-Powered Receives: Device: Human-Powered Nebulizer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Peak Expiratory Flow
Measured: From before to after nebulizer treatment lasting approximately 30 minutes
Secondary outcomes (1)
Improvement in blood oxygenation as measured by pulse oximetry
Measured: From before to after nebulizer treatment lasting about 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2013 (estimated)
- Study startAug 2012
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marquette University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lars Olson, Marquette University
- Investigators
- Lars E Olson, Ph.D., Principal investigator, Marquette University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01795742
- Sponsor's protocol ID
- MU-HR-2433
- Status last verified
- Feb 2013
- First submitted
- 3 Feb 2013
- Last updated
- 21 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Hallberg CJ, Lysaught MT, Najarro RA, Cea Gil F, Villatoro C, Diaz de Uriarte AC, Olson LE. Treatment of asthma exacerbations with the human-powered nebuliser: a randomised parallel-group clinical trial. NPJ Prim Care Respir Med. 2014 Jun 26;24:14016. doi: 10.1038/npjpcrm.2014.16.
PubMed 24965834
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Equivalence of a Human-Powered Nebulizer to an Electric Nebulizer in the Treatment of Mild to Moderate Asthma in El Salvador
- ClinicalTrials.gov ID
- NCT01795742
- Acronym / sponsor ID
- MU-HR-2433
- Conditions
- Asthma
- Keywords
- Asthma, Nebulizers, Salbutamol, Developing Countries
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Marquette UniversityUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 21 Feb 2013 (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.
This is an equivalence study comparing an electric nebulizer with a human-powered nebulizer--one that does not need electricity--in the treatment of mild to moderate asthma exacerbations in a regional clinic in San Salvador, El Salvador.
Detailed description
The study design is to treat individuals suffering from mild to moderate exacerbations of asthma with nebulized salbutamol (2.5mg). Subjects will receive nebulization using either an electric nebulizer compressor or a human-powered nebulizer compressor. Improvement in peak expiratory flow will be the primary endpoint. Blood oxygenation levels as measured by pulse oximetry will be a secondary endpoint of the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electric Nebulizer | Active comparator | Device: Human-Powered NebulizerPulmo-Aide Model 5650D |
| Human-Powered Nebulizer | Experimental | Device: Human-Powered NebulizerHuman-Powered |
Who may qualify
- Ages
- 6 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Suffering from Mild or Moderate Asthma symptoms
- Increased respiratory rate, but not over 30 breaths per minute
- Reduced peak expiratory flow rate, but not less than 60% of normal
- Oxygen saturation levels reduced but greater than 90%
Key exclusion criteria (4 listed)
- Any other respiratory condition that would interfere with nebulizer treatment
- If any other medication is being taken at the time
- Pregnant women or women who may think they might be pregnant
- Never taken salbutamol before
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 |
|---|---|---|
| Human-Powered Nebulizer | Device | Electric Nebulizer, Human-Powered Nebulizer |
Primary outcome
Improvement in Peak Expiratory Flow
Time frame: From before to after nebulizer treatment lasting approximately 30 minutes
1 secondary outcome
Improvement in blood oxygenation as measured by pulse oximetry
Time frame: From before to after nebulizer treatment lasting about 30 minutes
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 21 Feb 2013.
- Derived from this study: PubMed 24965834Hallberg CJ, Lysaught MT, Najarro RA, Cea Gil F, Villatoro C, Diaz de Uriarte AC, Olson LE. Treatment of asthma exacerbations with the human-powered nebuliser: a randomised parallel-group clinical trial. NPJ Prim Care Respir Med. 2014 Jun 26;24:14016. doi: 10.1038/npjpcrm.2014.16.
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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.
Lars E Olson, Ph.D. principal investigator
Marquette University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Human-Powered Nebulizer in people with Asthma, run by Marquette University at 1 site in El Salvador.
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 4 inclusion and 4 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 21 Feb 2013. 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 El Salvador. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Improvement in Peak Expiratory Flow (time frame: From before to after nebulizer treatment lasting approximately 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01795742, which also lists 1 linked publication.
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 21 Feb 2013.