Use of Aptar Digital Health's Respiratory Disease Management Platform for Asthma

NCT06364527 | Completed

• 1 other identifier: ADH-BSA-02-23
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

The United Kingdom has a high prevalence of asthma (over 12%) and some of the worst health outcomes in Europe. The management of respiratory disease and associated patient outcomes has long been an area of focus and improvement for the National Health Service. With the advancement of digital health technology, there is the potential to transform patient care and improve outcomes. The Aptar Digital Health respiratory disease management platform, a digital therapeutic will be utilized to determine its value and how it supports: i) asthma patient engagement and facilitates communication between patients and providers to accelerate medication adherence; ii) asthma control through the use of the Asthma Control Questionnaire-5. In addition, spirometry and fractioned exhaled nitric oxide will be utilized during the study to validate and enhance current National Institute for Health and Care Excellence guidelines.

Conditions

Asthma Chronic

Outcome Measures

Primary Outcomes (1)

• Asthma Control Questionnaire - 5 scores

  Asthma Control Questionnaire - 5 has 5 questions each ranging from a low of 0 to a high of 6. 0 indicates "never" and 6 indicates "always". The minimum mean score is a 0 and the highest mean score is a 6. The lower the score the better the outcome. Change in normal distribution and mean Asthma Control Questionnaire - 5 scores from baseline to 6 months, which is the end of the study.

  6 months

Secondary Outcomes (3)

• Mini-Asthma Quality of Life Questionnaire

  6 months

• Daily controller medication adherence

  6 months

• Step up to asthma-related biologics

  6 months

Other Outcomes (8)

• Asthma exacerbations

  6 months

• FeV1

  6 months

• FeNO

  6 months

Interventions

Aptar Digital Health respiratory disease management platform DEVICE

The Aptar Digital Health respiratory disease management platform is a digital health tool that combines a Healthcare Professional portal (BreatheSmart Connect) and an associated patient mobile application (BreatheSmart mobile application). The Aptar Digital Health respiratory disease management platform is intended to be used in conjunction with compatible connected sensor devices that track medication adherence and for some, technique.

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

• Age \< 16 years
• FeNO \< 35 ppb
• Known or suspected alcohol or drug abuse which in opinion of investigator could interfere with subject's proper completion of the protocol requirement
• History of life-threatening asthma: Defined as an asthma episode that required intubation and/or was associated with hypercapnea, respiratory arrest or hypoxic seizures within last 6 months
• A lower respiratory tract infection within 7 days of the screening visit ● Concurrent diagnosis of chronic obstructive pulmonary disease (COPD) or other respiratory disorders including active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases.
• History of hypersensitivity/intolerance to any components of the study inhalers (example, lactose, magnesium stearate). In addition, subjects with a history of severe milk protein allergy that, in the opinion of the study physician, contraindicates participation will also be excluded.
• Ever received treatment with biological based therapy example, omalizumab, mepolizumab, for asthma.
• Received an investigational drug and/or medical device within 30 days of entry into this study (Screening), or within five drug half-lives of the investigational drug, whichever is longer
• An immediate family member of the participating investigator, sub-investigator, study coordinator, employee of the participating investigator, or any family member of a Aptar Pharma, Aptar Digital Health, Voluntis, or Cohero employee.

Sponsors & Collaborators

• CoheroHealth: lead
• Aptar Digital Health: collaborator
• Lindus Health: collaborator

Study Sites (1)

Guy's and St. Thomas' NHS Foundation Trust

London, England, SE1 9RT, United Kingdom

Location

Related Publications (15)

• Barry LE, O'Neill C, Butler C, Chaudhuri R, Heaney LG. Cost-Effectiveness of Fractional Exhaled Nitric Oxide Suppression Testing as an Adherence Screening Tool Among Patients With Difficult-to-Control Asthma. J Allergy Clin Immunol Pract. 2023 Jun;11(6):1796-1804.e3. doi: 10.1016/j.jaip.2023.03.008. Epub 2023 Mar 20.

  PMID: 36940864 RESULT

• Boinet T, Leroy-David C. [Asthma in adults]. Actual Pharm. 2021 Feb;60(603):13-17. doi: 10.1016/j.actpha.2020.12.008. Epub 2021 Feb 22. French.

  PMID: 33642669 RESULT

• Nordon C, Grimaldi-Bensouda L, Pribil C, Nachbaur G, Amzal B, Thabut G, Marthan R, Aubier M; COBRA Study Group. Clinical and economic burden of severe asthma: A French cohort study. Respir Med. 2018 Nov;144:42-49. doi: 10.1016/j.rmed.2018.10.002. Epub 2018 Oct 2.

  PMID: 30366583 RESULT

• Budhathoki P, Shrestha DB, Rawal E, Khadka S. Corticosteroids in COVID-19: Is it Rational? A Systematic Review and Meta-Analysis. SN Compr Clin Med. 2020;2(12):2600-2620. doi: 10.1007/s42399-020-00515-6. Epub 2020 Oct 19.

  PMID: 33103063 RESULT

• George M, Bender B. New insights to improve treatment adherence in asthma and COPD. Patient Prefer Adherence. 2019 Jul 31;13:1325-1334. doi: 10.2147/PPA.S209532. eCollection 2019.

  PMID: 31534319 RESULT

• Busse WW, Kraft M. Current unmet needs and potential solutions to uncontrolled asthma. Eur Respir Rev. 2022 Jan 25;31(163):210176. doi: 10.1183/16000617.0176-2021. Print 2022 Mar 31.

  PMID: 35082128 RESULT

• McDonald VM, Yorke J. Adherence in severe asthma: time to get it right. Eur Respir J. 2017 Dec 21;50(6):1702191. doi: 10.1183/13993003.02191-2017. Print 2017 Dec. No abstract available.

  PMID: 29269587 RESULT

• Barnes CB, Ulrik CS. Asthma and adherence to inhaled corticosteroids: current status and future perspectives. Respir Care. 2015 Mar;60(3):455-68. doi: 10.4187/respcare.03200. Epub 2014 Aug 12.

  PMID: 25118311 RESULT

• Jackson DJ, Busby J, Pfeffer PE, Menzies-Gow A, Brown T, Gore R, Doherty M, Mansur AH, Message S, Niven R, Patel M, Heaney LG; UK Severe Asthma Registry. Characterisation of patients with severe asthma in the UK Severe Asthma Registry in the biologic era. Thorax. 2021 Mar;76(3):220-227. doi: 10.1136/thoraxjnl-2020-215168. Epub 2020 Dec 9.

  PMID: 33298582 RESULT

• Blakey JD, Bender BG, Dima AL, Weinman J, Safioti G, Costello RW. Digital technologies and adherence in respiratory diseases: the road ahead. Eur Respir J. 2018 Nov 22;52(5):1801147. doi: 10.1183/13993003.01147-2018. Print 2018 Nov.

  PMID: 30409819 RESULT

• Merchant R, Szefler SJ, Bender BG, Tuffli M, Barrett MA, Gondalia R, Kaye L, Van Sickle D, Stempel DA. Impact of a digital health intervention on asthma resource utilization. World Allergy Organ J. 2018 Dec 3;11(1):28. doi: 10.1186/s40413-018-0209-0. eCollection 2018.

  PMID: 30524644 RESULT

• Chan A, De Simoni A, Wileman V, Holliday L, Newby CJ, Chisari C, Ali S, Zhu N, Padakanti P, Pinprachanan V, Ting V, Griffiths CJ. Digital interventions to improve adherence to maintenance medication in asthma. Cochrane Database Syst Rev. 2022 Jun 13;6(6):CD013030. doi: 10.1002/14651858.CD013030.pub2.

  PMID: 35691614 RESULT

• Lara M, Edelen MO, Eberhart NK, Stucky BD, Sherbourne CD. Development and validation of the RAND Asthma Control Measure. Eur Respir J. 2014 Nov;44(5):1243-52. doi: 10.1183/09031936.00051614. Epub 2014 Jul 17.

  PMID: 25034567 RESULT

• Sherbourne CD, Stucky BD, Edelen MO, Eberhart NK, Kleerup E, Lara M. Assessing the validity of the RAND negative impact of asthma on quality of life short forms. J Allergy Clin Immunol. 2014 Oct;134(4):900-7. doi: 10.1016/j.jaci.2014.03.002. Epub 2014 Apr 18.

  PMID: 24746752 RESULT

• Rudin RS, Fanta CH, Qureshi N, Duffy E, Edelen MO, Dalal AK, Bates DW. A Clinically Integrated mHealth App and Practice Model for Collecting Patient-Reported Outcomes between Visits for Asthma Patients: Implementation and Feasibility. Appl Clin Inform. 2019 Oct;10(5):783-793. doi: 10.1055/s-0039-1697597. Epub 2019 Oct 16.

  PMID: 31618782 RESULT

Related Links

• Global Initiative for Asthma (GINA). Global Strategy for Asthma Management and Prevention, 2022.
• World Health Organization (WHO). Asthma. 12 May 2022.
• American Academy of Pediatrics. (2022). Mild, moderate, severe asthma: what do grades mean?
• NICE. Asthma: diagnosis, monitoring, and chronic asthma management. NICE guideline NG80. March 22, 2021.
• NICE. Medicines adherence: involving patients in decisions about prescribed medicines and supporting adherence. NICE guidance CG76. January 28, 2009.
• NICE. Measuring fractional exhaled nitric oxide concentration in asthma: NIOX MINO, NIOX VERO, and NObreath. NICE guidance DG12. April 2, 2014.
• Oxford Academic Health Science Network. Consensus pathway for management of uncontrolled asthma in adults. June 2022.

Study Officials

• David J Jackson, MRCP MSc PhD

  Consultant in Asthma & Eosinophilic Lung Diseases

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2024
• First Posted: April 15, 2024
• Study Start: July 18, 2024
• Primary Completion: January 27, 2026
• Study Completion: January 27, 2026
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

GB (1)