AsthmaNCT03420651
Peak Expiratory Flow Rate for Emergency Department Management of Acute Asthma Exacerbation
A study testing Peak Expiratory Flow Rate (PEFR) and Standard Clinical Judgement in people with Asthma, run by Hennepin Healthcare Research Institute at 1 site in United States.
Trial summary
Patients presenting to the emergency department with acute asthma exacerbation will be assigned to peak-expiratory flow rate (PEFR) guided management and non-PEFR guided management. Read more about this study
- Who is it for?
- Ages 16 to 55 years
- Conditions the study is for
- Asthma
- What is being tested?
- Peak Expiratory Flow Rate (PEFR) and Standard Clinical Judgement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jan 2018to 30 Nov 2022
- Phase
- Interventional
- 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 16 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Presumed diagnosis of asthma, requiring at least 2 nebulized albuterol treatments
- Presenting with acute asthma exacerbation defined as acute or subacute episodes of progressively worsening shortness of breath, cough, wheezing, and chest tightness, or some combination of these symptoms
- Start of enrollment process must occur within 15 minutes of being roomed in the ED
- Working phone number and willingness to be contacted at least 72 hours following encounter
Who cannot join
- Prisoner or in custody
- Pregnant
- Known diagnosis of COPD
- Co-morbid medical conditions that patient is seeking treatment for concurrently
- Non-English speaking
- Unable to provide informed consent
- In the resuscitation bay or on non-invasive positive pressure ventilation (NPPV)
Trial locations and contacts
1 site in 1 country.
United States1 site
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
About this study
Official title: Peak Expiratory Flow Rate (PEFR) for Emergency Department Management of Acute Asthma
Patients presenting to the emergency department with acute asthma exacerbation will be assigned to peak-expiratory flow rate (PEFR) guided management and non-PEFR guided management.
Read the detailed description
It is common practice to use peak-expiratory flow rate (PEFR) as an indicator of severity in patients that present with acute asthma exacerbation. There is, however, little data supporting this practice.
A recent Canadian 20 site prospective observational cohort study of 805 ED patients with acute asthma exacerbation concluded PEFR was not useful in predicting need for hospitalization or relapse following discharge.
As this was a cohort observational study, the conclusions that can be drawn are limited by the lack of randomization and control; it is necessary to conduct a randomized controlled trial to quantify how much time is expended caring for these patients, and gather safety data.
This is important because no studies have quantified differences in resource utilization based on PEFR-guided management compared to non-PEFR-guided management. It is possible physicians following PEFR-guided management use comparatively more resources, such as nebulizer treatments and hospitalization, in order to treat low PEFR values in patients they would have otherwise discharged based on clinical judgement alone. If outcomes are not affected by non-PEFR-guided management, it may reduce resource utilization to avoid using PEFR-guided management.
The investigators seek to determine if PEFR-based management and non-PEFR-based management perform similarly in guiding ED management of acute asthma exacerbations. Specifically, they seek to determine if the proportion of patients with no or mild asthma symptoms at 150 minutes after enrollment arrival is similar in the two groups.
At 150 minutes, it is expected that approximately 80% of patients will have no or mild asthma symptoms in both groups. When comparing the proportion of patients between the two groups, a confidence interval less than 20% wide (10% on either side of the point estimate) is desired. Therefore, goal enrollment is 110 patients per group.
This study will only include patients who are discharged from the ED. Patients who are enrolled and then eventually admitted to the hospital will be tabulated but excluded from the analysis.
Statistical analysis will compare the difference in the proportion of patients who achieve the primary outcome between groups, with the associated 95% confidence interval. Secondary outcomes will be presented descriptively; depending on the final distribution of the data, the investigators will present the means or medians of the data with the associated difference in mean/median with the associated 95% confidence intervals
- Conditions
- Asthma
- Being tested
- Peak Expiratory Flow Rate (PEFR), Standard Clinical Judgement
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peak Expiratory Flow Rate (PEFR)Other
PEFR values and the National Asthma Prevention and Education Program guidelines will be used by providers in the management of these patients.
Standard Clinical JudgementOther
Providers will use physical exam and standard clinical judgement to guide management.
| Study group | Role | What they receive |
|---|---|---|
| PEFR Guided Management | Experimental | Peak Expiratory Flow Rate (PEFR) Patients in this group will perform PEFR testing every 30 minutes and this data along with the National Asthma Prevention and Education Program guidelines will be considered by primary ED medical providers in the management of this group. Receives: Other: Peak Expiratory Flow Rate (PEFR) |
| Non-PEFR Guided Management | Experimental | Standard Clinical Judgement Patients in this group will receive management based on primary medical provider's clinical judgement. Receives: Other: Standard Clinical Judgement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adequate control of asthma symptoms within 150 minutes
Proportion of patients reporting no or mild asthma symptoms at 150 minutes after enrollment
Measured: 150 minutes
Secondary outcomes (4)
Hospitalization during index encounter
Rate of hospitalization in both groups directly from initial ED encounter
Measured: 12 hours
ED Length of Stay
Time elapsed from when the patient is roomed until the time the MD places discharge order, by review of the Electronic Medical record by a blinded abstractor.
Measured: 12 hours
Number of nebulized treatments with short-acting beta antagonists (SABA)
This is defined as the number of nebulized treatments received in the emergency department during the encounter, by review of the Electronic Medical record by a blinded abstractor.
Measured: 12 hours
Relapse following discharge within 72 hours
Each patient will be assessed via chart review and telephone follow up to see if they visited an ED or urgent care for asthma symptoms during the 72 hour time frame. Rates of relapse will be compared between the two treatment arms.
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start19 Jan 2018
- Primary completion30 Nov 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hennepin Healthcare Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian Driver, Hennepin Healthcare Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03420651
- Sponsor's protocol ID
- 17-4459
- Status last verified
- Sep 2023
- First submitted
- 28 Jan 2018
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peak Expiratory Flow Rate (PEFR) for Emergency Department Management of Acute Asthma
- ClinicalTrials.gov ID
- NCT03420651
- Acronym / sponsor ID
- 17-4459
- Conditions
- Asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- Hennepin Healthcare Research InstituteUniversity, hospital or other
- Study start
- 19 Jan 2018 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 5 Feb 2018 (actual)
- 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.
Patients presenting to the emergency department with acute asthma exacerbation will be assigned to peak-expiratory flow rate (PEFR) guided management and non-PEFR guided management.
Detailed description
It is common practice to use peak-expiratory flow rate (PEFR) as an indicator of severity in patients that present with acute asthma exacerbation. There is, however, little data supporting this practice.
A recent Canadian 20 site prospective observational cohort study of 805 ED patients with acute asthma exacerbation concluded PEFR was not useful in predicting need for hospitalization or relapse following discharge.
As this was a cohort observational study, the conclusions that can be drawn are limited by the lack of randomization and control; it is necessary to conduct a randomized controlled trial to quantify how much time is expended caring for these patients, and gather safety data.
This is important because no studies have quantified differences in resource utilization based on PEFR-guided management compared to non-PEFR-guided management. It is possible physicians following PEFR-guided management use comparatively more resources, such as nebulizer treatments and hospitalization, in order to treat low PEFR values in patients they would have otherwise discharged based on clinical judgement alone. If outcomes are not affected by non-PEFR-guided management, it may reduce resource utilization to avoid using PEFR-guided management.
The investigators seek to determine if PEFR-based management and non-PEFR-based management perform similarly in guiding ED management of acute asthma exacerbations. Specifically, they seek to determine if the proportion of patients with no or mild asthma symptoms at 150 minutes after enrollment arrival is similar in the two groups.
At 150 minutes, it is expected that approximately 80% of patients will have no or mild asthma symptoms in both groups. When comparing the proportion of patients between the two groups, a confidence interval less than 20% wide (10% on either side of the point estimate) is desired. Therefore, goal enrollment is 110 patients per group.
This study will only include patients who are discharged from the ED. Patients who are enrolled and then eventually admitted to the hospital will be tabulated but excluded from the analysis.
Statistical analysis will compare the difference in the proportion of patients who achieve the primary outcome between groups, with the associated 95% confidence interval. Secondary outcomes will be presented descriptively; depending on the final distribution of the data, the investigators will present the means or medians of the data with the associated difference in mean/median with the associated 95% confidence intervals
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEFR Guided Management | Experimental | Other: Peak Expiratory Flow Rate (PEFR)Peak Expiratory Flow Rate (PEFR) Patients in this group will perform PEFR testing every 30 minutes and this data along with the National Asthma Prevention and Education Program guidelines will be considered by primary ED medical providers in the management of this group. |
| Non-PEFR Guided Management | Experimental | Other: Standard Clinical JudgementStandard Clinical Judgement Patients in this group will receive management based on primary medical provider's clinical judgement. |
Who may qualify
- Ages
- 16 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Presumed diagnosis of asthma, requiring at least 2 nebulized albuterol treatments
- Presenting with acute asthma exacerbation defined as acute or subacute episodes of progressively worsening shortness of breath, cough, wheezing, and chest tightness, or some combination of these symptoms
- Start of enrollment process must occur within 15 minutes of being roomed in the ED
- Working phone number and willingness to be contacted at least 72 hours following encounter
Key exclusion criteria (7 listed)
- Prisoner or in custody
- Pregnant
- Known diagnosis of COPD
- Co-morbid medical conditions that patient is seeking treatment for concurrently
- Non-English speaking
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 |
|---|---|---|
| Peak Expiratory Flow Rate (PEFR)PEFR values and the National Asthma Prevention and Education Program guidelines will be used by providers in the management of these patients. | Other | PEFR Guided Management |
| Standard Clinical JudgementProviders will use physical exam and standard clinical judgement to guide management. | Other | Non-PEFR Guided Management |
Primary outcome
Adequate control of asthma symptoms within 150 minutes
Time frame: 150 minutes
Proportion of patients reporting no or mild asthma symptoms at 150 minutes after enrollment
4 secondary outcomes
Hospitalization during index encounter
Time frame: 12 hours
ED Length of Stay
Time frame: 12 hours
Number of nebulized treatments with short-acting beta antagonists (SABA)
Time frame: 12 hours
Relapse following discharge within 72 hours
Time frame: 72 hours
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 Sep 2023.
- Individual participant dataSharing planned: No
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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 study testing Peak Expiratory Flow Rate (PEFR) and Standard Clinical Judgement in people with Asthma, run by Hennepin Healthcare Research Institute 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 4 inclusion and 7 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 Sep 2023. 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?
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?
Adequate control of asthma symptoms within 150 minutes (time frame: 150 minutes). 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 21 Sep 2023.