Study to Determine the Impact of BreatheSmart on Asthma Control in Adult Asthmatics

Asthma Clinical Trial

Official title:

A Prospective, Observational Study to Assess Changes in Asthma Control in Adults With Asthma Managed on BreatheSmart

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05712863
• Other study ID #: CH-001
• Status: Completed
• Phase: N/A
• Start date: April 21, 2017
• Est. completion date: August 29, 2018

Study information

• Verified date: January 2023
• Source: CoheroHealth
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

• Mobile Spirometer that offers remote clinical-grade lung function monitoring

• BreatheSmart mobile application that sends subjects real-time alerts and allow patients to enter quality of life data.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: August 29, 2018
• Est. primary completion date: August 29, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male and/or female adults (aged = 18 years)

• Ability to provide written informed consent

• Owns a compatible smartphone (iOS 8.0 or higher, or Android 4.3 or higher) and is familiar with the download and management of software applications

• Diagnosis of persistent asthma for at least 6 months duration with evidence of poorly controlled disease defined as having at least one of the following within 12 months prior to consent:

• exacerbation of asthma symptoms requiring pulse of corticosteroids

• acute asthma event that resulted in an emergency department or urgent care visit

• hospitalization for asthma related care

• Managed on inhaled corticosteroid (ICS) medication for at least 3 months prior to enrollment. Stable dose of oral corticosteroids and/or biologic therapy is also permissable

• Use of a pressurized metered dose inhaler (pMDI) compatible with the HeroTracker

• Non-smoker, or = 10 pack/year history of tobacco use and abstinence for at least 1 year

Exclusion Criteria:

• Presence of other significant chronic lung disease or condition such as chronic obstructive pulmonary disease, cystic fibrosis, interstitial lung disease, chronic lung disease of prematurity, recurrent aspiration, primary pulmonary hypertension, or presence of tracheostomy

• Presence of other chronic medical conditions such as congenital heart disease or immunodeficiency,

• Presence of other comorbidities that, in the opinion of the investigator, will interfere with the collection of study procedures, or limit life expectancy to < 1 year

• Currently pregnant/breast feeding or planning to become pregnant during the study period

• Primary language other than English or Spanish

Related Conditions & MeSH terms

• Asthma

Intervention

Device:
• BreatheSmart
BreatheSmart is a comprehensive asthma monitoring system combining medical devices and a mobile application designed for use with iOS and Android operating systems. Using Bluetooth to connect, the devices sync with the mobile application to facilitate the collection of medication adherence and lung function data.

Locations

Country	Name	City	State
United States	North Westchester Hospital	Mount Kisco	New York

Sponsors (2)

Lead Sponsor	Collaborator
CoheroHealth	Databean

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 months
Primary	Change in rescue medication usage	Determine change in rescue medication usage in subjects using the BreatheSmart system from baseline to 3 months.	3 months
Secondary	Change in controller medication adherence	We plan to obtain the medication adherence percentage (that ranges from 0-100%) to asthma inhaled corticosteroids (ICS) at baseline, 1 month post-baseline, 2-months post-baseline, and 3-months post-baseline. We will then display the monthly averaged medication treatment adherence and calculate the difference in medication adherence between baseline and 3-months post-baseline, which will be expressed as a percentage increase or decrease.	3 months