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Behavioural Intervention
Smartphone Evaluation for Airway Diseases (AWARE Trial)
N/A
Recruiting
Led By Erick Forno, MD MPH
Research Sponsored by Indiana University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 8-65 years
No respiratory or other major disease (for healthy controls), or physician-diagnosed asthma, COPD, CF, or other airway diseases
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to two weeks per subject
Awards & highlights
No Placebo-Only Group
Summary
This trial will test if smartphones can be used to check the size of the airways, find blockages, help diagnose airway diseases, and spot when the disease gets worse.
Who is the study for?
This trial is for individuals with airway conditions like Bronchiectasis, Ciliary Motility Disorders, COPD, Cystic Fibrosis, Asthma or a floppy airway. It's also open to healthy people who can serve as controls. Specific eligibility criteria are not provided.
What is being tested?
The AWARE (Acoustic Waveform Respiratory Evaluation) study tests if smartphone speakers and microphones can measure airway size, detect blockages, help diagnose airway diseases and spot when the disease gets worse.
What are the potential side effects?
Since this trial involves non-invasive technology using smartphones there may be minimal to no side effects associated with participating in this study.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 8 and 65 years old.
Select...
I do not have major diseases or I have a diagnosed airway disease like asthma.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to two weeks per subject
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to two weeks per subject
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Accurate and reliable disease diagnosis
Estimation of AX
Estimation of FEF2575
+8 moreSecondary study objectives
Reliable screening for disease diagnosis
Screening of AX
Screening of FEF2575
+8 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
5Treatment groups
Experimental Treatment
Group I: Other Airway DiseasesExperimental Treatment1 Intervention
This group will include subjects with airway ciliary motility disorders, bronchiectasis, and airway malaria. Given variability in the clinical presentation and diagnosis of these conditions, they will be ascertained by physician diagnosis and reviewed by study physician investigators.
Group II: Healthy ControlsExperimental Treatment1 Intervention
This will include generally healthy subjects who do not have any of the airway diseases included in the study, nor other chronic cardiorespiratory or other diseases that may alter lung function or the ability to participate in the study.
Group III: Cystic Fibrosis (CF)Experimental Treatment1 Intervention
Physician diagnosis based on U.S. CF Foundation guidelines, including signs/symptoms of CF and either a positive sweat chloride test (\>60 mmol/L), or an indeterminate sweat chloride test (30-59 mmol/L) plus two CF-causing CFTR mutations. The study may include subjects with different CFTR mutation classes as well as both on and off CFTR modulators.
Group IV: Chronic Obstructive Pulmonary Disease (COPD)Experimental Treatment1 Intervention
Physician diagnosis, plus symptoms of COPD per GOLD guidelines, plus post-bronchodilator FEV1/FVC \<0.70 or below the lower limit of normal (LLN) using GLI reference equations.
Group V: AsthmaExperimental Treatment1 Intervention
Physician diagnosis plus at least one of the following in the past year: asthma symptoms that improve with albuterol; prescribed asthma controller medication(s); an acute asthma exacerbation requiring systemic steroids; or an emergency department visit or hospitalization for asthma. Alternatively, report of current asthma symptoms per US NAEPP or Global Initiative for Asthma (GINA) guidelines, plus documentation of bronchodilator response or airway hyperresponsiveness.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AWARE
2018
N/A
~280
Find a Location
Who is running the clinical trial?
Indiana UniversityLead Sponsor
1,045 Previous Clinical Trials
1,316,084 Total Patients Enrolled
8 Trials studying Cystic Fibrosis
1,358 Patients Enrolled for Cystic Fibrosis
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,943 Previous Clinical Trials
47,797,099 Total Patients Enrolled
38 Trials studying Cystic Fibrosis
12,662 Patients Enrolled for Cystic Fibrosis
University of PittsburghOTHER
1,792 Previous Clinical Trials
16,359,186 Total Patients Enrolled
15 Trials studying Cystic Fibrosis
121,430 Patients Enrolled for Cystic Fibrosis
Erick Forno, MD MPHPrincipal InvestigatorIndiana University