AsthmaNCT03103880

Assessing the Use of Mobile Technology in Adult Asthma Patients

A study testing BreatheSmart in people with Asthma, run by CoheroHealth at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This is a prospective, remote observational study of adults with persistent asthma who are managed on inhaled corticosteroids. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Asthma
What is being tested?: BreatheSmart
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 104 participants
Where: 1 siteUnited States
Study dates: 21 Apr 2017to 29 Aug 2018
Phase: Interventional
Are there results?: None posted in the registry

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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Ability to provide written informed consent
Male and female adults (aged ≥ 18 years)
Diagnosis of asthma for at least 6 months
ICS (inhaled corticosteroid) use for at least 3 months
Use of a pressurized metered dose inhaler (pMDI) compatible with the HeroTracker
Possess a compatible smartphone (iOS 8.0 or higher and Android 4.3 or higher)

Who cannot join

Currently pregnant or planning to become pregnant during the study period
Primary language other than English (BreatheSmart mobile app is currently available only in English)

Trial locations and contacts

1 site in 1 country.

United States1 site

Cohero Health, Inc.
New York, New York, 10017

Other trials in United States

About this study

Official title: Assessing the Use of Digital Therapeutic in Adult Asthma Patients: A Remote Observational Study

This is a prospective, remote observational study of adults with persistent asthma who are managed on inhaled corticosteroids.

Read the detailed description

The study consists of one interventional group and all 104 subjects will be included in this group. All subjects will be provided with the HeroTracker package, which includes:

HeroTracker sensor that counts dosage and monitors real-time medication adherence
BreatheSmart mobile application that sends subjects real-time alerts and allows patients respond to questionnaires / surveys.

Conditions: Asthma
Being tested: BreatheSmart
Keywords: Patient adherence, Mobile application, Mobile health, Digital therapeutics, Digital health
Medical subject headings: Asthma, Patient Compliance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BreatheSmartDevice
BreatheSmart is a comprehensive asthma monitoring system that combines a medical device and mobile application that are designed for use with Apple and Android mobile devices. The medical device connects to the mobile application using Bluetooth to facilitate the collection of controlled medication adherence, rescue medication usage, and asthma control.

Study groups in NCT03103880
Study group	Role	What they receive
BreatheSmart	Experimental	104 subjects will be provided with the BreatheSmart platform, which consists of: 1. HeroTracker sensor that monitors real-time asthma medication adherence 2. BreatheSmart mobile application that provides patients with real-time alerts, environmental information (weather, pollution, etc.), and the ability to complete questionnaires / surveys. Receives: Device: BreatheSmart

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in asthma control
Determine change in the asthma control test (ACT), a validated asthma test, in subjects using the BreatheSmart system from baseline to 3 months.
Measured: 3 months
Change in rescue medication usage
Determine change in rescue medication usage in subjects the BreatheSmart system from baseline to 3 months.
Measured: 3 months

Secondary outcomes (2)

Change in controller medication adherence
Obtain medication adherence percentage (that ranges from 0-100%) to asthma inhaled corticosteroids (ICS) at baseline to 3 months.
Measured: 3 months
Acceptability of BreatheSmart system
Acceptability questionnaire (delivered through the BreatheSmart mobile application) that includes subjects' opinion on the platform, features, usability, and usefulness.
Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Apr 201729 Aug 2018

First posted6 Apr 2017
Study start21 Apr 2017
Primary completion29 Aug 2018
Study completion29 Aug 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (7)Papers the sponsor has linked to this study.
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: Health services research
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 104 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03103880
Sponsor's protocol ID: 2017 Observational Study 1.0
Status last verified: Jul 2024
First submitted: 28 Mar 2017
Last updated: 30 Jul 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Lasmar L, Camargos P, Champs NS, Fonseca MT, Fontes MJ, Ibiapina C, Alvim C, Moura JA. Adherence rate to inhaled corticosteroids and their impact on asthma control. Allergy. 2009 May;64(5):784-9. doi: 10.1111/j.1398-9995.2008.01877.x. Epub 2009 Jan 21.
PubMed 19183166
Chan AH, Harrison J, Black PN, Mitchell EA, Foster JM. Using electronic monitoring devices to measure inhaler adherence: a practical guide for clinicians. J Allergy Clin Immunol Pract. 2015 May-Jun;3(3):335-49.e1-5. doi: 10.1016/j.jaip.2015.01.024. Epub 2015 Apr 1.
PubMed 25840665
Schatz M, Kosinski M, Yarlas AS, Hanlon J, Watson ME, Jhingran P. The minimally important difference of the Asthma Control Test. J Allergy Clin Immunol. 2009 Oct;124(4):719-23.e1. doi: 10.1016/j.jaci.2009.06.053. Epub 2009 Sep 19.
PubMed 19767070
Jia CE, Zhang HP, Lv Y, Liang R, Jiang YQ, Powell H, Fu JJ, Wang L, Gibson PG, Wang G. The Asthma Control Test and Asthma Control Questionnaire for assessing asthma control: Systematic review and meta-analysis. J Allergy Clin Immunol. 2013 Mar;131(3):695-703. doi: 10.1016/j.jaci.2012.08.023. Epub 2012 Oct 8.
PubMed 23058645
Melosini L, Dente FL, Bacci E, Bartoli ML, Cianchetti S, Costa F, Di Franco A, Malagrino L, Novelli F, Vagaggini B, Paggiaro P. Asthma control test (ACT): comparison with clinical, functional, and biological markers of asthma control. J Asthma. 2012 Apr;49(3):317-23. doi: 10.3109/02770903.2012.661008. Epub 2012 Mar 9.
PubMed 22401649
Korn S, Both J, Jung M, Hubner M, Taube C, Buhl R. Prospective evaluation of current asthma control using ACQ and ACT compared with GINA criteria. Ann Allergy Asthma Immunol. 2011 Dec;107(6):474-9. doi: 10.1016/j.anai.2011.09.001. Epub 2011 Oct 5.
PubMed 22123375
Melvin E, Cushing A, Tam A, Kitada R, Manice M. Assessing the use of BreatheSmart(R) mobile technology in adult patients with asthma: a remote observational study. BMJ Open Respir Res. 2017 Aug 16;4(1):e000204. doi: 10.1136/bmjresp-2017-000204. eCollection 2017.
PubMed 29071077

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Asthma trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Assessing the Use of Digital Therapeutic in Adult Asthma Patients: A Remote Observational Study
ClinicalTrials.gov ID: NCT03103880
Acronym / sponsor ID: 2017 Observational Study 1.0
Conditions: Asthma
Keywords: Patient adherence, Mobile application, Mobile health, Digital therapeutics, Digital health
Study type: Interventional
Recruitment status: Completed
Enrolment: 104 participants (actual)
Lead sponsor: CoheroHealthIndustry (pharma, biotech, devices)
Study start: 21 Apr 2017 (actual)
Primary completion: 29 Aug 2018 (actual)
Study completion: 29 Aug 2018 (actual)
First posted: 6 Apr 2017 (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.

This is a prospective, remote observational study of adults with persistent asthma who are managed on inhaled corticosteroids.

Detailed description

The study consists of one interventional group and all 104 subjects will be included in this group. All subjects will be provided with the HeroTracker package, which includes:

HeroTracker sensor that counts dosage and monitors real-time medication adherence
BreatheSmart mobile application that sends subjects real-time alerts and allows patients respond to questionnaires / surveys.

Study design

Primary purpose: Health services research
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
BreatheSmart	Experimental	Device: BreatheSmart104 subjects will be provided with the BreatheSmart platform, which consists of: 1. HeroTracker sensor that monitors real-time asthma medication adherence 2. BreatheSmart mobile application that provides patients with real-time alerts, environmental information (weather, pollution, etc.), and the ability to complete questionnaires / surveys.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Ability to provide written informed consent
Male and female adults (aged ≥ 18 years)
Diagnosis of asthma for at least 6 months
ICS (inhaled corticosteroid) use for at least 3 months
Use of a pressurized metered dose inhaler (pMDI) compatible with the HeroTracker

Key exclusion criteria (2 listed)

Currently pregnant or planning to become pregnant during the study period
Primary language other than English (BreatheSmart mobile app is currently available only in English)

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
BreatheSmartBreatheSmart is a comprehensive asthma monitoring system that combines a medical device and mobile application that are designed for use with Apple and Android mobile devices. The medical device connects to the mobile application using Bluetooth to facilitate the collection of controlled medication adherence, rescue medication usage, and asthma control.	Device	BreatheSmart

Primary outcome

Change in asthma control
Time frame: 3 months
Determine change in the asthma control test (ACT), a validated asthma test, in subjects using the BreatheSmart system from baseline to 3 months.
Change in rescue medication usage
Time frame: 3 months
Determine change in rescue medication usage in subjects the BreatheSmart system from baseline to 3 months.

2 secondary outcomes

Change in controller medication adherence
Time frame: 3 months
Acceptability of BreatheSmart system
Time frame: 3 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
Background: PubMed 19183166Lasmar L, Camargos P, Champs NS, Fonseca MT, Fontes MJ, Ibiapina C, Alvim C, Moura JA. Adherence rate to inhaled corticosteroids and their impact on asthma control. Allergy. 2009 May;64(5):784-9. doi: 10.1111/j.1398-9995.2008.01877.x. Epub 2009 Jan 21.
Background: PubMed 25840665Chan AH, Harrison J, Black PN, Mitchell EA, Foster JM. Using electronic monitoring devices to measure inhaler adherence: a practical guide for clinicians. J Allergy Clin Immunol Pract. 2015 May-Jun;3(3):335-49.e1-5. doi: 10.1016/j.jaip.2015.01.024. Epub 2015 Apr 1.
Background: PubMed 19767070Schatz M, Kosinski M, Yarlas AS, Hanlon J, Watson ME, Jhingran P. The minimally important difference of the Asthma Control Test. J Allergy Clin Immunol. 2009 Oct;124(4):719-23.e1. doi: 10.1016/j.jaci.2009.06.053. Epub 2009 Sep 19.
Background: PubMed 23058645Jia CE, Zhang HP, Lv Y, Liang R, Jiang YQ, Powell H, Fu JJ, Wang L, Gibson PG, Wang G. The Asthma Control Test and Asthma Control Questionnaire for assessing asthma control: Systematic review and meta-analysis. J Allergy Clin Immunol. 2013 Mar;131(3):695-703. doi: 10.1016/j.jaci.2012.08.023. Epub 2012 Oct 8.
Background: PubMed 22401649Melosini L, Dente FL, Bacci E, Bartoli ML, Cianchetti S, Costa F, Di Franco A, Malagrino L, Novelli F, Vagaggini B, Paggiaro P. Asthma control test (ACT): comparison with clinical, functional, and biological markers of asthma control. J Asthma. 2012 Apr;49(3):317-23. doi: 10.3109/02770903.2012.661008. Epub 2012 Mar 9.
Background: PubMed 22123375Korn S, Both J, Jung M, Hubner M, Taube C, Buhl R. Prospective evaluation of current asthma control using ACQ and ACT compared with GINA criteria. Ann Allergy Asthma Immunol. 2011 Dec;107(6):474-9. doi: 10.1016/j.anai.2011.09.001. Epub 2011 Oct 5.
Derived from this study: PubMed 29071077Melvin E, Cushing A, Tam A, Kitada R, Manice M. Assessing the use of BreatheSmart(R) mobile technology in adult patients with asthma: a remote observational study. BMJ Open Respir Res. 2017 Aug 16;4(1):e000204. doi: 10.1136/bmjresp-2017-000204. eCollection 2017.
Individual participant dataSharing planned: No

Related trials for Asthma

RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
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Active, not recruitingPhase 2/3
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RecruitingPhase 2
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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. This study is not recruiting at the moment.

Anne Tam, MPH study director

Cohero Health, Inc.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing BreatheSmart in people with Asthma, run by CoheroHealth at 1 site 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 6 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: finished, as of the sponsor's last update on 30 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in asthma control (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03103880, which also lists 7 linked publications.

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 30 Jul 2024.