CLINICAL TRIAL

Peak Expiratory Flow Rate (PEFR) for Asthma

1 Prior Treatment
Relapsed
Recruiting · < 65 · All Sexes · Minneapolis, MN

This study is evaluating whether a new method of measuring how fast air can be exhaled from the lungs may help treat asthma.

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About the trial for Asthma

Eligible Conditions
Asthma · Emergencies

Treatment Groups

This trial involves 2 different treatments. Peak Expiratory Flow Rate (PEFR) is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Experimental Group 1
Standard Clinical Judgement
OTHER
Experimental Group 2
Peak Expiratory Flow Rate (PEFR)
OTHER

Eligibility

This trial is for patients born any sex aged 65 and younger. You must have received 1 prior treatment for Asthma or the other condition listed above. There are 4 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
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
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 150 minutes
Screening: ~3 weeks
Treatment: Varies
Reporting: 150 minutes
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 150 minutes.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Peak Expiratory Flow Rate (PEFR) will improve 1 primary outcome and 4 secondary outcomes in patients with Asthma. Measurement will happen over the course of 12 hours.

Number of nebulized treatments with short-acting beta antagonists (SABA)
12 HOURS
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.
12 HOURS
Hospitalization during index encounter
12 HOURS
Rate of hospitalization in both groups directly from initial ED encounter
12 HOURS
ED Length of Stay
12 HOURS
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.
12 HOURS
Relapse following discharge within 72 hours
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.
72 HOURS
Adequate control of asthma symptoms within 150 minutes
150 MINUTES
Proportion of patients reporting no or mild asthma symptoms at 150 minutes after enrollment
150 MINUTES

Who is running the study

Principal Investigator
B.
Brianver, Director of Clinical Research
Hennepin Healthcare Research Institute

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the signs of asthma?

Asthma affects lung function and can lead to symptoms related to airway obstruction. This includes: wheezing, shortness of breath, and breathlessness. Asthma can also lead to a dry cough and in severe cases, difficulty breathing.\n

Anonymous Patient Answer

Can asthma be cured?

Patients treated with BTS/budesonide, an acceptable and rigorous therapeutic approach, achieved complete disease control rate. Results from a recent paper suggest that moderate and severe uncontrolled asthma can be effectively controlled with daily dosing of an acceptable dose of corticosteroid under BTS.

Anonymous Patient Answer

What are common treatments for asthma?

Anticholinergics and corticosteroids are the most common prescription drugs prescribed to patients with uncontrolled asthma, but education and asthma control measures are also often used. Antihistamines are not commonly prescribed to patients with asthma in Canada. Some patients have prescribed treatments not proven to be effective, and this has been a cause for concern. The impact of overuse of inhaled corticosteroid prescriptions depends on the definition of "overuse" given in the report: the report of overuse is based on the patient's subjective experience and can be influenced by confounding factors and by non-adherence to prescribed treatment regimens.

Anonymous Patient Answer

How many people get asthma a year in the United States?

Asthma affects around 20 million Americans every year because of wheezing and chronic air flow obstruction. Approximately 2 million are hospitalized because of asthma in a year in the United States. The National Asthma Education Foundation and National Institutes of Health provide educational materials on asthma.

Anonymous Patient Answer

What is asthma?

Our answers do not completely match the answers reported in the national and international literature. However, we believe we have captured the general concept behind asthma from the perspective of patients for those who are living with it.

Anonymous Patient Answer

What causes asthma?

There are several potential causes of asthma. Most asthma occurs in children, and is most frequently associated with the body's response to allergies and other inhaled environmental chemicals. Some causes of asthma can be mitigated, though not entirely reversed. Most of the environmental exposure that is thought to cause asthma, including cigarette smoke, is not, however, reversed by removing smokers from the air they breathe. It is important to make asthma awareness a priority.

Anonymous Patient Answer

How serious can asthma be?

Those suffering from asthma usually have to carry the disease at home and have to struggle everyday with the symptoms. Asthma may affect their day-to-day life considerably. Asthma patients have to take the extra effort in carrying out normal activities. This can affect their social life adversely, and may sometimes make it difficult for them to enter the university. In order to reduce the symptoms of asthma, the patient or a caregiver has to give themselves an education about asthma so that they can properly take their medications and take the correct dosages. Asthma is common and it should be treated in the right manner.

Anonymous Patient Answer

What does peak expiratory flow rate (pefr) usually treat?

Patient and physician views of PEFRs are sufficiently different that there are important differences in the way PEFRs are used for asthma treatment. Current practice of using PEFRs to guide therapy is not consistent with current knowledge and is not based on objective evidence. The current emphasis on PEFRs in asthma treatment may be over-driven by personal experience or lack of objective evidence.

Anonymous Patient Answer

What are the latest developments in peak expiratory flow rate (pefr) for therapeutic use?

Although the correlation is not 1, there is a strong correlation between the level of PEF and the level of symptoms experienced in asthmatics. A correlation exists between PEF and symptoms with a coefficient of 0.78, which suggests that PEF measurement is a useful tool to monitor symptom status and help to detect asthma flareups. Thus PEF can be considered a useful objective parameter to follow the symptoms objectively in asthmatics. PEF is a significant and useful objective tool that may help establish early treatment, and is likely a clinically useful tool to help tailor inhaled bronchodilator therapy for asthmatics.

Anonymous Patient Answer

Have there been other clinical trials involving peak expiratory flow rate (pefr)?

There are many different trials concerning PEF measurements, though most have been conducted in an outpatient setting in the West. PEF is not used in clinical practice, and clinicians might be concerned that it may compromise patient-provider relationships by interfering with the doctor-patient relationship. Future research should focus on this concern. In addition, since PEF studies have relied heavily on patient self-report questions on the day of enrollment, the degree to which one can assume the validity of the results is limited. Additionally, research is limited in demonstrating what type of self-reported data can be used to assess asthma control. Findings from a recent study was conducted to evaluate the validity of self-reported data.

Anonymous Patient Answer

What are the common side effects of peak expiratory flow rate (pefr)?

Results from a recent paper provides a guide on prescribing peak expiratory flow rates for inhaler patients with asthma and the common side effects of PEFR measurement in those with asthma. Clinicians prescribing PEFs for use in patients with asthma, may not always be aware of the possibility of a PEFR > or = 70% of peak of norm. Physicians should be aware that PEFR is not a marker for disease activity.

Anonymous Patient Answer
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