AsthmaAWARENCT06512064
Acoustic Waveform Respiratory Evaluation
A study testing AWARE in people with Asthma and COPD, run by Indiana University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma, COPD, Cystic Fibrosis
- What is being tested?
- AWARE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 2 sitesUnited States
- Study dates
- 23 Jul 2024to Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Age 8-70 years (to ensure ability to perform other PFTs; up to 75 years for COPD subjects in the UPMC adult clinic only).
- Ability to perform spirometry and oscillometry
- Signed informed consent (and assent for children as appropriate)
- No respiratory or other major disease (for healthy controls), or physician-diagnosed asthma, COPD, CF, or other airway diseases
Who cannot join
- Inability or unwillingness to perform AWARE, spirometry, or oscillometry
- 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)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Indiana University
Indianapolis, Indiana, 46202
Erick Forno, MD MPH
- Recruiting
University of Pittsburgh
Pittsburgh, Pennsylvania, 15224
Juan C Celedón, MD DrPH
About this study
Official title: Advancing Telemedicine in Pulmonology: Acoustic-waveform Respiratory Evaluation (AWARE) Via Sensing and Machine Learning on Smartphones
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.
Read the detailed description
Asthma and COPD respectively affect millions of people in the US. Chronic lower respiratory diseases represented the fourth leading cause of death in the country before the pandemic. For these and other pulmonary diseases like cystic fibrosis (CF), monitoring disease remotely but objectively could lead to marked improvements in disease control, quality of life, and overall prognosis. However, current disease monitoring and management often rely on subjective symptom report, and objective pulmonary function tests (PFTs) are often only done a handful of times a year at subspecialty referral centers. The primary hypothesis for this study is that smartphone-based sensing and machine learning (ML) approaches can advance pulmonary telemedicine by enabling comprehensive pulmonary disease evaluation with high accuracy, reliability, and adaptability. The investigators further hypothesize that AWARE can accurately help identify different lung diseases, estimate lung function, and detect changes associated with exacerbations. In Aim 1, investigators will develop and improve a smartphone sensing approach as an accurate and reliable aide in airway disease diagnosis. Investigators will recruit a sample of healthy individuals and individuals with asthma, COPD, CF, and other airway diseases, to assess whether AWARE can accurately classify subjects in their disease groups. In Aim 2, investigators will improve the ML approach to estimate lung function accurately and adaptively, including traditional PFT indices from spirometry and impulse oscillometry. And in Aim 3, investigators will develop deep learning techniques to identify changes in airway conditions associated disease exacerbations, by performing AWARE during stable disease and acute exacerbations. For these aims, investigators will recruit a cohort of pediatric and adult subjects with a wide range of demographic and anthropometric characteristics, to have adequate representation of various airway diseases, a broad range of lung function, and the ability to obtain measurements during acute disease exacerbations. The study protocol will include study questionnaires, anthropometry, body composition, and three sets of PFTs: spirometry, oscillometry, and AWARE. A subgroup of subjects will additionally perform AWARE at home for up to two weeks, allowing investigators to evaluate supervised vs unsupervised and in-clinic vs. at-home measurements. Similarly, a subgroup of subjects will perform AWARE dual testing (i.e., with both study smartphones and their own smartphone) to evaluate repeatability using diverse equipment and software platforms.
- Conditions
- Asthma, COPD, Cystic Fibrosis, Ciliary Motility Disorders, Bronchiectasis, Airway Malacia
- Being tested
- AWARE
- Medical subject headings
- Asthma, Pulmonary Disease, Chronic Obstructive, Cystic Fibrosis, Ciliary Motility Disorders, Bronchiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AWAREDiagnostic test
AWARE testing to estimate lung function and aid in disease diagnosis
| Study group | Role | What they receive |
|---|---|---|
| Asthma | Experimental | 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. Receives: Diagnostic Test: AWARE |
| Chronic Obstructive Pulmonary Disease (COPD) | Experimental | 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. Receives: Diagnostic Test: AWARE |
| Cystic Fibrosis (CF) | Experimental | 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. Receives: Diagnostic Test: AWARE |
| Other Airway Diseases | Experimental | 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. Receives: Diagnostic Test: AWARE |
| Healthy Controls | Experimental | 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. Receives: Diagnostic Test: AWARE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accurate and reliable disease diagnosis
Ability of AWARE to accurately classify subjects into the study disease categories with high accuracy (>80% sensitivity and >80% overall accuracy)
Measured: Up to two weeks per subject
Estimation of FEV1
Ability of AWARE to estimate FEV1 with high accuracy (<5% error compared to spirometry measures). FEV1 (forced expiratory volume in 1 second) is a measurement of how much air a person can exhale in the first second after inhaling.
Measured: Up to two weeks per subject
Estimation of FVC
Ability of AWARE to estimate FVC with high accuracy (<5% error compared to spirometry measures). FVC (forced vital capacity) is a measurement of the maximum amount of air a person can exhale after a deep breath in.
Measured: Up to two weeks per subject
Estimation of FEV1/FVC
Ability of AWARE to estimate FEV1/FVC with high accuracy (<5% error compared to spirometry measures). FEV1/FVC is the proportion of the forced vital capacity (FVC) that is exhaled in the first second (FEV1).
Measured: Up to two weeks per subject
Estimation of FEF2575
Ability of AWARE to estimate FEF2575 with high accuracy (<5% error compared to spirometry measures). FEF25-75% is defined as forced expiratory flow over the middle one-half of the FVC (the average flow from the point at which 25% of the FVC has been exhaled to the point at which 75% of the FVC has been exhaled).
Measured: Up to two weeks per subject
Estimation of R5
Ability of AWARE to estimate R5 with high accuracy (<10% error compared to oscillometry measures). R5 (also known as Rrs5), assessed by oscillometry, is the airway resistance to sound waves at a frequency of 5 Hz.
Measured: Up to two weeks per subject
Estimation of R20
Ability of AWARE to estimate R20 with high accuracy (<10% error compared to oscillometry measures). R20 (also known as Rrs20), assessed by oscillometry, is the airway resistance to sound waves at a frequency of 20 Hz.
Measured: Up to two weeks per subject
Estimation of R5-R20
Ability of AWARE to estimate R5-R20 with high accuracy (<10% error compared to oscillometry measures). R5-R20 (also known as Rrs5-Rrs20) is a measurement of small airway dysfunction typically assessed via oscillometry in which the difference in airway resistance to sound waves of 5 Hz and 20 Hz is calculated.
Measured: Up to two weeks per subject
Estimation of X5
Ability of AWARE to estimate X5 with high accuracy (<10% error compared to oscillometry measures). X5 (also known as Xrs5), assessed by oscillometry, is the airway reactance to sound waves at a frequency of 5 Hz.
Measured: Up to two weeks per subject
Estimation of AX
Ability of AWARE to estimate AX with high accuracy (<10% error compared to oscillometry measures). AX (area of reactance) is a lung function measurement of the lung's ability to store energy for passive expiration obtained via oscillometry. AX is measured by the area under the reactance curve from lowest frequency to the resonant frequency.
Measured: Up to two weeks per subject
Identification of airway changes associated disease exacerbations
Ability of AWARE to identify disease exacerbations (>80% sensitivity and >80% overall accuracy).
Measured: Up to two weeks per subject
Secondary outcomes (11)
Reliable screening for disease diagnosis
Ability of AWARE to classify subjects into the study disease categories with adequate sensitivity (>70%) and accuracy (>50%) for use as a screening test
Measured: Up to two weeks per subject
Screening of FEV1
Ability of AWARE to estimate FEV1 with acceptable accuracy (<10% error) for use as a screening test.
Measured: Up to two weeks per subject
Screening of FVC
Ability of AWARE to estimate FVC with acceptable accuracy (<10% error) for use as a screening test
Measured: Up to two weeks per subject
Screening of FEV1/FVC
Ability of AWARE to estimate FEV1/FVC with acceptable accuracy (<10% error) for use as a screening test
Measured: Up to two weeks per subject
Screening of FEF2575
Ability of AWARE to estimate FEF2575 with acceptable accuracy (<10% error) for use as a screening test
Measured: Up to two weeks per subject
Screening of R5
Ability of AWARE to estimate R5 with acceptable accuracy (<20% error) for use as a screening test
Measured: Up to two weeks per subject
Screening of R20
Ability of AWARE to estimate R20 with acceptable accuracy (<20% error) for use as a screening test
Measured: Up to two weeks per subject
Screening of R5-R20
Ability of AWARE to estimate R5-R20 with acceptable accuracy (<20% error) for use as a screening test
Measured: Up to two weeks per subject
Screening of X5
Ability of AWARE to estimate X5 with acceptable accuracy (<20% error) for use as a screening test
Measured: Up to two weeks per subject
Screening of AX
Ability of AWARE to estimate AX with acceptable accuracy (<20% error) for use as a screening test
Measured: Up to two weeks per subject
Screening of airway changes associated disease exacerbations
Ability of AWARE to identify disease exacerbations with adequate accuracy for use as a screening test (>70% sensitivity and >50% overall accuracy)
Measured: Up to two weeks per subject
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start23 Jul 2024
- Primary completionApr 2029 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erick Forno, Indiana University
- Investigators
- Erick Forno, MD MPH, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06512064
- Sponsor's protocol ID
- 20030
- Other IDs
- R01HL170368
- Acronym
- AWARE
- Status last verified
- Sep 2026
- First submitted
- 26 Jun 2024
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advancing Telemedicine in Pulmonology: Acoustic-waveform Respiratory Evaluation (AWARE) Via Sensing and Machine Learning on Smartphones
- ClinicalTrials.gov ID
- NCT06512064
- Acronym / sponsor ID
- AWARE / 20030
- Conditions
- Asthma, COPD, Cystic Fibrosis, Ciliary Motility Disorders, Bronchiectasis, Airway Malacia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), University of Pittsburgh
- Study start
- 23 Jul 2024 (actual)
- Primary completion
- Apr 2029 (estimated)
- Study completion
- Apr 2029 (estimated)
- First posted
- 22 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Asthma and COPD respectively affect millions of people in the US. Chronic lower respiratory diseases represented the fourth leading cause of death in the country before the pandemic. For these and other pulmonary diseases like cystic fibrosis (CF), monitoring disease remotely but objectively could lead to marked improvements in disease control, quality of life, and overall prognosis. However, current disease monitoring and management often rely on subjective symptom report, and objective pulmonary function tests (PFTs) are often only done a handful of times a year at subspecialty referral centers. The primary hypothesis for this study is that smartphone-based sensing and machine learning (ML) approaches can advance pulmonary telemedicine by enabling comprehensive pulmonary disease evaluation with high accuracy, reliability, and adaptability. The investigators further hypothesize that AWARE can accurately help identify different lung diseases, estimate lung function, and detect changes associated with exacerbations. In Aim 1, investigators will develop and improve a smartphone sensing approach as an accurate and reliable aide in airway disease diagnosis. Investigators will recruit a sample of healthy individuals and individuals with asthma, COPD, CF, and other airway diseases, to assess whether AWARE can accurately classify subjects in their disease groups. In Aim 2, investigators will improve the ML approach to estimate lung function accurately and adaptively, including traditional PFT indices from spirometry and impulse oscillometry. And in Aim 3, investigators will develop deep learning techniques to identify changes in airway conditions associated disease exacerbations, by performing AWARE during stable disease and acute exacerbations. For these aims, investigators will recruit a cohort of pediatric and adult subjects with a wide range of demographic and anthropometric characteristics, to have adequate representation of various airway diseases, a broad range of lung function, and the ability to obtain measurements during acute disease exacerbations. The study protocol will include study questionnaires, anthropometry, body composition, and three sets of PFTs: spirometry, oscillometry, and AWARE. A subgroup of subjects will additionally perform AWARE at home for up to two weeks, allowing investigators to evaluate supervised vs unsupervised and in-clinic vs. at-home measurements. Similarly, a subgroup of subjects will perform AWARE dual testing (i.e., with both study smartphones and their own smartphone) to evaluate repeatability using diverse equipment and software platforms.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Asthma | Experimental | Diagnostic Test: AWAREPhysician 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. |
| Chronic Obstructive Pulmonary Disease (COPD) | Experimental | Diagnostic Test: AWAREPhysician 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. |
| Cystic Fibrosis (CF) | Experimental | Diagnostic Test: AWAREPhysician 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. |
| Other Airway Diseases | Experimental | Diagnostic Test: AWAREThis 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. |
| Healthy Controls | Experimental | Diagnostic Test: AWAREThis 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. |
Who may qualify
- Ages
- 8 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Age 8-70 years (to ensure ability to perform other PFTs; up to 75 years for COPD subjects in the UPMC adult clinic only).
- Ability to perform spirometry and oscillometry
- Signed informed consent (and assent for children as appropriate)
- No respiratory or other major disease (for healthy controls), or physician-diagnosed asthma, COPD, CF, or other airway diseases
Key exclusion criteria (2 listed)
- Inability or unwillingness to perform AWARE, spirometry, or oscillometry
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AWAREAWARE testing to estimate lung function and aid in disease diagnosis | Diagnostic test | Asthma, Chronic Obstructive Pulmonary Disease (COPD), Cystic Fibrosis (CF), Healthy Controls, Other Airway Diseases |
Primary outcome
Accurate and reliable disease diagnosis
Time frame: Up to two weeks per subject
Ability of AWARE to accurately classify subjects into the study disease categories with high accuracy (>80% sensitivity and >80% overall accuracy)
Estimation of FEV1
Time frame: Up to two weeks per subject
Ability of AWARE to estimate FEV1 with high accuracy (<5% error compared to spirometry measures). FEV1 (forced expiratory volume in 1 second) is a measurement of how much air a person can exhale in the first second after inhaling.
Estimation of FVC
Time frame: Up to two weeks per subject
Ability of AWARE to estimate FVC with high accuracy (<5% error compared to spirometry measures). FVC (forced vital capacity) is a measurement of the maximum amount of air a person can exhale after a deep breath in.
Estimation of FEV1/FVC
Time frame: Up to two weeks per subject
Ability of AWARE to estimate FEV1/FVC with high accuracy (<5% error compared to spirometry measures). FEV1/FVC is the proportion of the forced vital capacity (FVC) that is exhaled in the first second (FEV1).
Estimation of FEF2575
Time frame: Up to two weeks per subject
Ability of AWARE to estimate FEF2575 with high accuracy (<5% error compared to spirometry measures). FEF25-75% is defined as forced expiratory flow over the middle one-half of the FVC (the average flow from the point at which 25% of the FVC has been exhaled to the point at which 75% of the FVC has been exhaled).
Estimation of R5
Time frame: Up to two weeks per subject
Ability of AWARE to estimate R5 with high accuracy (<10% error compared to oscillometry measures). R5 (also known as Rrs5), assessed by oscillometry, is the airway resistance to sound waves at a frequency of 5 Hz.
Estimation of R20
Time frame: Up to two weeks per subject
Ability of AWARE to estimate R20 with high accuracy (<10% error compared to oscillometry measures). R20 (also known as Rrs20), assessed by oscillometry, is the airway resistance to sound waves at a frequency of 20 Hz.
Estimation of R5-R20
Time frame: Up to two weeks per subject
Ability of AWARE to estimate R5-R20 with high accuracy (<10% error compared to oscillometry measures). R5-R20 (also known as Rrs5-Rrs20) is a measurement of small airway dysfunction typically assessed via oscillometry in which the difference in airway resistance to sound waves of 5 Hz and 20 Hz is calculated.
Estimation of X5
Time frame: Up to two weeks per subject
Ability of AWARE to estimate X5 with high accuracy (<10% error compared to oscillometry measures). X5 (also known as Xrs5), assessed by oscillometry, is the airway reactance to sound waves at a frequency of 5 Hz.
Estimation of AX
Time frame: Up to two weeks per subject
Ability of AWARE to estimate AX with high accuracy (<10% error compared to oscillometry measures). AX (area of reactance) is a lung function measurement of the lung's ability to store energy for passive expiration obtained via oscillometry. AX is measured by the area under the reactance curve from lowest frequency to the resonant frequency.
Identification of airway changes associated disease exacerbations
Time frame: Up to two weeks per subject
Ability of AWARE to identify disease exacerbations (>80% sensitivity and >80% overall accuracy).
11 secondary outcomes
Reliable screening for disease diagnosis
Time frame: Up to two weeks per subject
Screening of FEV1
Time frame: Up to two weeks per subject
Screening of FVC
Time frame: Up to two weeks per subject
Screening of FEV1/FVC
Time frame: Up to two weeks per subject
Screening of FEF2575
Time frame: Up to two weeks per subject
Screening of R5
Time frame: Up to two weeks per subject
Screening of R20
Time frame: Up to two weeks per subject
Screening of R5-R20
Time frame: Up to two weeks per subject
Screening of X5
Time frame: Up to two weeks per subject
Screening of AX
Time frame: Up to two weeks per subject
Screening of airway changes associated disease exacerbations
Time frame: Up to two weeks per subject
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
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Asthma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Erick Forno, MD MPH principal investigator
Indiana University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AWARE in people with Asthma and COPD, run by Indiana University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elizabeth Rizzi, RN (317-626-6937, lizbuell@iu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accurate and reliable disease diagnosis (time frame: Up to two weeks per subject). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.