Recruiting

Observational Study

Sponsor:

Indiana University

Code:

NCT06512064

Conditions

Asthma

COPD

Cystic Fibrosis

Ciliary Motility Disorders

Bronchiectasis

Eligibility Criteria

Sex: All

Age: 8 - 70

Healthy Volunteers: Accepted

Interventions

AWARE

Study Details

Brief summary:

The study will evaluate the feasibility of using smartphone speakers and microphones to evaluate the caliber of the airways, detect airway obstruction, aid in airway disease diagnosis, and identify disease exacerbations.

Conditions

Asthma

COPD

Cystic Fibrosis

Ciliary Motility Disorders

Bronchiectasis

Study ID

NCT06512064

Start date

Jul 23, 2024

Status verified date

Oct, 2025

Completion date

Apr, 2029

Anticipated

Primary completion date

Apr, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8 - 70

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Age 8-70 years
2. Ability to perform spirometry and oscillometry
3. Signed informed consent (and assent for children as appropriate)
4. No respiratory or other major disease (for healthy controls), or physician-diagnosed asthma, COPD, CF, or other airway diseases

Exclusion Criteria:

1. Inability or unwillingness to perform AWARE, spirometry, or oscillometry
2. Acute or chronic illness that, at the judgement of investigators, may affect lung function and alter the results of AWARE or the reference PFTs (spirometry and AOS)

Study Design

Enrollment

800 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Asthma

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.

experimental: Chronic Obstructive Pulmonary Disease (COPD)

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.

experimental: Cystic Fibrosis (CF)

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.

experimental: Other Airway Diseases

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.

experimental: Healthy Controls

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.

Interventions

AWARE

AWARE testing to estimate lung function and aid in disease diagnosis

Primary outcome measure

  • Accurate and reliable disease diagnosis [ Time Frame: Up to two weeks per subject ]
  • Estimation of FEV1 [ Time Frame: Up to two weeks per subject ]
  • Estimation of FVC [ Time Frame: Up to two weeks per subject ]
  • Estimation of FEV1/FVC [ Time Frame: Up to two weeks per subject ]
  • Estimation of FEF2575 [ Time Frame: Up to two weeks per subject ]
  • Estimation of R5 [ Time Frame: Up to two weeks per subject ]
  • Estimation of R20 [ Time Frame: Up to two weeks per subject ]
  • Estimation of R5-R20 [ Time Frame: Up to two weeks per subject ]
  • Estimation of X5 [ Time Frame: Up to two weeks per subject ]
  • Estimation of AX [ Time Frame: Up to two weeks per subject ]
  • Identification of airway changes associated disease exacerbations [ Time Frame: Up to two weeks per subject ]

Central Contacts and Locations

Central contacts

Elizabeth Rizzi, RN

317-626-6937lizbuell@iu.edu

Lisa Bendy, RRT

317-278-7152lbendy@iu.edu

Locations

Indiana University

Recruiting

Indianapolis, Indiana, United States, 46202

University of Pittsburgh

Recruiting

Pittsburgh, Pennsylvania, United States, 15224

More Information

Sponsor

Indiana University

Last update posted

Oct 24, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-11. This information was provided to ClinicalTrials.gov by Indiana University on 2025-10-24.