AsthmaNCT01045174
Breath-Actuated Nebulizer Versus Conventional Continuous-Output Nebulizer in Pediatric Asthma Patients
A study testing Nebulizer (breath-actuated versus conventional continuous-output) in people with Asthma, run by University Hospitals Cleveland Medical Center at 1 site in United States.
Trial summary
A Breath-Actuated Nebulizer is a newer type of nebulizer device that creates aerosol only when a patient is inhaling, rather than creating aerosol continuously. It is thought that breath-actuated nebulizer devices may deliver asthma rescue medications to patients' lungs more effectively and therefore lead them to… Read more about this study
- Who is it for?
- Ages 1 year to 17 years
- Conditions the study is for
- Asthma
- What is being tested?
- Nebulizer (breath-actuated versus conventional continuous-output)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to Dec 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 1 year to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children 1-17 years old with known history of asthma
- children must be presenting to the emergency department for treatment of acute asthma
- children must qualify to be treated for acute asthma according to an existing standardized asthma care algorithm
Who cannot join
- concomitant chronic respiratory or cardiac disease such as cystic fibrosis, congenital heart disease, or bronchopulmonary dysplasia
- no prior history of asthma
- pregnancy
- reported history of drug allergy to albuterol or ipratropium bromide
- previous participation in the study within the preceding three weeks
- vital sign instability/need for immediate emergency intervention to prevent clinical deterioration
Trial locations and contacts
1 site in 1 country.
United States1 site
Rainbow Babies and Children's Hospital/University Hospitals of Cleveland Pediatric Emergency Department
Cleveland, Ohio, 44106
About this study
Official title: A Randomized Controlled Trial Comparing the Effectiveness of a Breath-Actuated Nebulizer Device Versus a Conventional Continuous-Output Nebulizer in Treating Pediatric Asthma Patients in the Emergency Department
A Breath-Actuated Nebulizer is a newer type of nebulizer device that creates aerosol only when a patient is inhaling, rather than creating aerosol continuously. It is thought that breath-actuated nebulizer devices may deliver asthma rescue medications to patients' lungs more effectively and therefore lead them to recover from asthma attacks faster than conventional continuous-output nebulizer devices. This study compares outcomes including hospital admission rates, number of nebulized treatments required, and patient/family satisfaction when a breath-actuated nebulizer device versus a conventional continuous-output nebulizer is used to deliver asthma medications to pediatric asthma patients in the emergency department.
- Conditions
- Asthma
- Being tested
- Nebulizer (breath-actuated versus conventional continuous-output)
- Keywords
- Asthma, Pediatric, Emergency department, Nebulizer
- Medical subject headings
- Asthma, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nebulizer (breath-actuated versus conventional continuous-output)Device
Participants are randomly assigned to receive bronchodilator treatments for asthma according to the standard of care using either a breath-actuated nebulizer device or a conventional continuous-output nebulizer. Standard unit doses of albuterol/ipratropium bromide or albuterol are used in both devices.
| Study group | Role | What they receive |
|---|---|---|
| Breath-Actuated Nebulizer | Active comparator | Participants are randomly assigned to receive bronchodilator treatments for asthma according to the standard of care using either a breath-actuated nebulizer device or a conventional continuous-output nebulizer. Receives: Device: Nebulizer (breath-actuated versus conventional continuous-output) |
| Conventional continuous-ouput nebulizer | Active comparator | Participants are randomly assigned to receive bronchodilator treatments for asthma according to the standard of care using either a breath-actuated nebulizer device or a conventional continuous-output nebulizer Receives: Device: Nebulizer (breath-actuated versus conventional continuous-output) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Admission to Hospital for Asthma Exacerbation
Number (and percentage) of children in each study group requiring admission to the hospital for asthma exacerbation/status asthmaticus from the Pediatric Emergency Department (as opposed to being discharged to home)
Measured: 24 hours (whether patient is admitted after presenting to emergency department for asthma or discharged home)
Secondary outcomes (3)
Length of Stay in the Emergency Department After Presenting for Asthma Exacerbation
Length of stay in the emergency department measured in minutes; up to 400 minutes measured
Measured: only measures length of stay in emergency department on date of presentation
Patient's Satisfaction With Using Assigned Nebulizer (as Assessed by Brief Survey)
Percentage of patients (or caregivers of younger children) who "agreed" or "strongly agreed" on a brief survey (using a 5-point Likert scale) that they would feel comfortable with using the same nebulizer device to take asthma treatments in the future. Likert-type scale was used, on which score of 1=strongly disagree, 2=disagree, 3=neither agree nor disagree (or unsure), 4=agree, and 5=strongly agree.
Measured: within time frame of emergency department stay (up to 400 minutes from initial presentation to pediatric ED)
Difficulty (if Any) Encountered by Patients With Using Assigned Nebulizer Device
Measured: number of children who had difficulty using assigned nebulizer device during the timeframe of the ED visit during which the study nebulizer was used. Timeframe for outcome measure was length of single emergency department visit, up to 400 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2010 (estimated)
- Study startDec 2008
- Primary completionDec 2010
- Study completionDec 2010
Why it stopped: change in availability of study investigators
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by University Hospitals Cleveland Medical CenterThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jerri A. Rose, University Hospitals Cleveland Medical Center
- Investigators
- Jerri A Rose, M.D., Principal investigator, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01045174
- Sponsor's protocol ID
- UH IRB # 09-08-06
- Status last verified
- Nov 2020
- First submitted
- 7 Jan 2010
- Last updated
- 25 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing the Effectiveness of a Breath-Actuated Nebulizer Device Versus a Conventional Continuous-Output Nebulizer in Treating Pediatric Asthma Patients in the Emergency Department
- ClinicalTrials.gov ID
- NCT01045174
- Acronym / sponsor ID
- UH IRB # 09-08-06
- Conditions
- Asthma
- Keywords
- Asthma, Pediatric, Emergency department, Nebulizer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: change in availability of study investigators
- Enrolment
- 180 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 8 Jan 2010 (estimated)
- Results
- Posted 25 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Breath-Actuated Nebulizer is a newer type of nebulizer device that creates aerosol only when a patient is inhaling, rather than creating aerosol continuously. It is thought that breath-actuated nebulizer devices may deliver asthma rescue medications to patients' lungs more effectively and therefore lead them to recover from asthma attacks faster than conventional continuous-output nebulizer devices. This study compares outcomes including hospital admission rates, number of nebulized treatments required, and patient/family satisfaction when a breath-actuated nebulizer device versus a conventional continuous-output nebulizer is used to deliver asthma medications to pediatric asthma patients in the emergency department.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breath-Actuated Nebulizer | Active comparator | Device: Nebulizer (breath-actuated versus conventional continuous-output)Participants are randomly assigned to receive bronchodilator treatments for asthma according to the standard of care using either a breath-actuated nebulizer device or a conventional continuous-output nebulizer. |
| Conventional continuous-ouput nebulizer | Active comparator | Device: Nebulizer (breath-actuated versus conventional continuous-output)Participants are randomly assigned to receive bronchodilator treatments for asthma according to the standard of care using either a breath-actuated nebulizer device or a conventional continuous-output nebulizer |
Who may qualify
- Ages
- 1 year to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- children 1-17 years old with known history of asthma
- children must be presenting to the emergency department for treatment of acute asthma
- children must qualify to be treated for acute asthma according to an existing standardized asthma care algorithm
Key exclusion criteria (6 listed)
- concomitant chronic respiratory or cardiac disease such as cystic fibrosis, congenital heart disease, or bronchopulmonary dysplasia
- no prior history of asthma
- pregnancy
- reported history of drug allergy to albuterol or ipratropium bromide
- previous participation in the study within the preceding three weeks
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 |
|---|---|---|
| Nebulizer (breath-actuated versus conventional continuous-output)Participants are randomly assigned to receive bronchodilator treatments for asthma according to the standard of care using either a breath-actuated nebulizer device or a conventional continuous-output nebulizer. Standard unit doses of albuterol/ipratropium bromide or albuterol are used in both devices. | Device | Breath-Actuated Nebulizer, Conventional continuous-ouput nebulizer |
Primary outcome
Rate of Admission to Hospital for Asthma Exacerbation
Time frame: 24 hours (whether patient is admitted after presenting to emergency department for asthma or discharged home)
Number (and percentage) of children in each study group requiring admission to the hospital for asthma exacerbation/status asthmaticus from the Pediatric Emergency Department (as opposed to being discharged to home)
3 secondary outcomes
Length of Stay in the Emergency Department After Presenting for Asthma Exacerbation
Time frame: only measures length of stay in emergency department on date of presentation
Patient's Satisfaction With Using Assigned Nebulizer (as Assessed by Brief Survey)
Time frame: within time frame of emergency department stay (up to 400 minutes from initial presentation to pediatric ED)
Difficulty (if Any) Encountered by Patients With Using Assigned Nebulizer Device
Time frame: number of children who had difficulty using assigned nebulizer device during the timeframe of the ED visit during which the study nebulizer was used. Timeframe for outcome measure was length of single emergency department visit, up to 400 minutes.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Jerri A Rose, M.D. principal investigator
University Hospitals Cleveland Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nebulizer (breath-actuated versus conventional continuous-output) in people with Asthma, run by University Hospitals Cleveland Medical Center at 1 site in United States.
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 6 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: stopped early, as of the sponsor's last update on 25 Nov 2020. 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 United States. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Rate of Admission to Hospital for Asthma Exacerbation (time frame: 24 hours (whether patient is admitted after presenting to emergency department for asthma or discharged home)). 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 25 Nov 2020.