CLINICAL TRIAL

Emmi for Asthma

Waitlist Available · 18+ · All Sexes · Pittsburgh, PA

This study is evaluating whether an internet-based intervention for insomnia can improve sleep quality and asthma control for adults with asthma.

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About the trial for Asthma

Eligible Conditions
Insomnia · Sleep Initiation and Maintenance Disorders · Asthma

Treatment Groups

This trial involves 2 different treatments. Emmi 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
SHUTi
BEHAVIORAL
Experimental Group 2
Emmi
BEHAVIORAL

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SHUTi
2018
N/A
~380

Eligibility

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Meets criteria for Insomnia Disorder
At least moderate insomnia severity as evidenced by an Insomnia Severity Index score > 7
Telephone, email address, reliable Internet access
Diagnosis of moderate-severe persistent asthma
Clinical diagnosis of asthma based on bronchodilator response or methacholine challenge testing
Not well-controlled asthma
Age 18-75 years
Stable doses and schedules (i.e., unchanged) of standard therapy for moderate to severe asthma for 2 months prior to enrollment
Have a current primary care physician
Stable medical, psychiatric conditions
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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: Change from Baseline to 3 & 6 months from start of intervention
Screening: ~3 weeks
Treatment: Varies
Reporting: Change from Baseline to 3 & 6 months from start of intervention
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Change from Baseline to 3 & 6 months from start of intervention.
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 Emmi will improve 1 primary outcome and 2 secondary outcomes in patients with Asthma. Measurement will happen over the course of Change from Baseline to 3 & 6 months from start of intervention.

Asthma Control Test (ACT)
CHANGE FROM BASELINE TO 3 & 6 MONTHS FROM START OF INTERVENTION
The Asthma Control Test is a 5-item questionnaire that measures asthma control by assessing interference with activity, shortness of breath, nocturnal symptoms, rescue medication use, and self-rating of asthma control. The total score ranges from 5 to 25, with higher scores indicating greater asthma control.
CHANGE FROM BASELINE TO 3 & 6 MONTHS FROM START OF INTERVENTION
The Insomnia Severity Index (ISI)
CHANGE FROM BASELINE TO 3 & 6 MONTHS FROM START OF INTERVENTION
The Insomnia Severity Index is a 7-item self-report questionnaire assessing nature, severity and impact of insomnia symptoms. The total score ranges from 0 to 28, with higher scores indicating worse insomnia severity.
CHANGE FROM BASELINE TO 3 & 6 MONTHS FROM START OF INTERVENTION
Asthma Quality of Life Questionnaire (AQLQ)
CHANGE FROM BASELINE TO 3 & 6 MONTHS FROM START OF INTERVENTION
The Asthma Quality of Life Questionnaire is a 32-item measure assessing asthma-specific health-related quality of life in 4 domains: activity limitations (ability to carry out daily activities), symptoms (frequency and nature of asthma symptoms such as coughing and chest tightness), emotional distress (intensity of the discomfort, fear, or distress associated with asthma), and environmental stimuli (capacity to manage environmental triggers of asthma such as smoke, dust, and pollution). An overall total score is computed by averaging the scores from the four domains. The total score ranges from 1 to 7, with higher scores indicating better quality of life.
CHANGE FROM BASELINE TO 3 & 6 MONTHS FROM START OF INTERVENTION

Who is running the study

Principal Investigator
F. L.
Prof. Faith Luyster, Assistant Professor
University of Pittsburgh

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 causes asthma?

Many genes, environmental and behavioral factors are at work in the development of asthma. Understanding more about these factors could lead to more effective therapies.

Anonymous Patient Answer

What are the signs of asthma?

Many signs of asthma are subtle and hard to detect. The common symptoms of asthma have been described in great detail and include wheezing, shortness of breath, chest tightness, and nausea and vomiting. Because many asthma symptoms may be similar to upper respiratory tract infections (urticaria, sneezes, or colds), people with asthma should seek medical attention if their symptoms are not improving. Symptoms of a more serious condition, such as a bronchospasm from an upper respiratory tract infection or a lung infection, usually resolve within 5 days. However, bronchospasms from asthma may respond rapidly to medication. For this reason, it is important for people with asthma to monitor the frequency and severity of symptoms.

Anonymous Patient Answer

What are common treatments for asthma?

While a wide range of medications are available, there isn't a consensus when it comes to medication recommendations. Most patients are switched back and forth between multiple medications in an attempt to control symptoms. Patients are also commonly given bronchodilators in an attempt to control their lung function. Future evidence development is needed to determine the efficacy and safety of inhaled and nasal corticosteroid treatment for asthma.

Anonymous Patient Answer

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

A total of 8.4 million cases will occur in the United States in 2010, making it the most common chronic respiratory disease in the country. This number of patients will decrease by 13% in 2030 due to increased awareness of the disease by medical providers and a declining prevalence of smoking among the general US population. The most common symptom, chronic cough, will remain widespread despite increased detection of chronic asthma, which has a much lower annual prevalence.

Anonymous Patient Answer

What is asthma?

Asthma is a long-term inflammatory disease characterised by bronchial hyperresponsiveness to allergens (atopic asthma) and/or infection (atopic asthma plus atopic dermatitis). There have been reported increases in its prevalence among adults and children in industrialized countries.\n

Anonymous Patient Answer

Can asthma be cured?

Asthma cannot be cured. However, most patients can enjoy complete symptom relief or in the case of more urgent exacerbations, an antihistamine or bronchodilator can be administered effectively.

Anonymous Patient Answer

What are the common side effects of emmi?

The most common adverse event was dry nose and throat (28%). No serious adverse reactions were reported. There were no statistically significant differences among patients taking emmi and placebo in any of the primary or secondary efficacy outcomes, safety profiles or quality of life assessments. Emmi is well tolerated with a low rate of adverse events by the doses and frequencies used. http://www.emi-international.com/EN/content/product-information.

Anonymous Patient Answer

Is emmi typically used in combination with any other treatments?

EMM can work together as a complement of any conventional asthma therapy in controlling asthma symptoms, and in improving lung function in mild to moderate cases with chronic allergic diseases including asthma. EMM can also help in controlling exacerbations including the onset of airway hyper-responsiveness.

Anonymous Patient Answer

What is the latest research for asthma?

The current literature has an increased number of trials for asthma compared to the last review. But a shortage of randomized trials is still an issue. Trial registration, reporting, and reporting of the results of clinical trials have to more standardised.

Anonymous Patient Answer

Does emmi improve quality of life for those with asthma?

The asthma programme for Emmi, which emphasizes the use of a wide range of effective non-invasive treatments, was effective for achieving meaningful improvements in the quality of life in people with asthma.

Anonymous Patient Answer

Have there been other clinical trials involving emmi?

In our studies the emmi was well tolerated. Results from a recent clinical trial support the need for further controlled studies in patients experiencing symptomatic exacerbation and/or refractory symptoms. It is important to note that emmi does not alter the effectiveness or safety of existing medicines used to treat conditions like asthma. We would propose a small study is urgently needed prior to implementing emmi as an OTC medicine.

Anonymous Patient Answer
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