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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 below

Select...

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to two weeks per subject for reporting.

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 more

Secondary study objectives

Reliable screening for disease diagnosis

Screening of AX

Screening of FEF2575

+8 more

Awards & 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

0 / 2Eligibility criteria met