A clinical study to evaluate the effect of the Connected Inhaler System (CIS) on adherence to maintenance therapy in poorly controlled asthmatic patients

Phase 1

• Conditions: Asthma; MedDRA version: 20.0Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2017-002266-45-DE
• Lead Sponsor: GlaxoSmithKline Research & Development Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-02
• Study Completion: 2019-01-24
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 437

Inclusion Criteria

1. Subjects aged 18 years or older, at the time of signing the informed consent.
2. Subjects with documented physician diagnosis of asthma as their primary respiratory disease.
3. Asthma Control Test (ACT) score <20 at screening visit
4. Non-smokers (never smoked or not smoking for >6 months with <10 pack years history (Pack years = [cigarettes per day smoked/20] x number of years smoked)
5. Male or Female subjects:
A female subject is eligible to participate if she is not pregnant (see Appendix 5 of the study protocol), not breastfeeding, and at least one of the following conditions applies:
(i) Not a woman of childbearing potential (WOCBP) as defined in Appendix 5 of the study protocol.
OR
(ii) A WOCBP who agrees to follow the contraceptive guidance in Appendix 5 of the study protocol during the treatment period and for at least 5 days] after the last dose of study treatment.
6. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the consent form and in this protocol.
7. Subject understands and is willing, able, and likely to comply with study procedures and restrictions.
8. Subject must be able to read in a language supported by the smart phone app in their region
9. Subject must have been on maintenance therapy (Fixed dose combination ICS/LABA) for 3 months, cannot have changed dose in the month prior to screening and be able to change to an equivalent dose of Relvar/Breo for the duration of the study. Other background asthma medication such as anti-leukotrienes and oral corticosteroids are permitted provided the dose has been stable for 1 month prior to screening.
10. Subject must be able to change to Salbutamol/Albuterol MDI rescue for the duration of the study and judged capable of withholding albuterol/salbutamol for at least 6 hours prior to study visits.
11. Subject must have their own Android or IOS smart phone and a data package suitable for the installation and running of the app and sending and receiving data. Data used by the CIS is approximately 1MB per month as a maximum; this is less data than a 1 minute video streamed from YouTube (2MB)).
12. Subjects must be willing and able to download the app on their personal smart phone and keep it turned on for the duration of the study. This will also require Bluetooth to be turned on for duration of the study. Subjects will also have to turn on mobile data for the app for the duration of study; unless travelling and when extra data roaming costs could be incurred.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 540
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

1. Subjects with a known or suspected alcohol or drug abuse which in the opinion of the investigator could interfere with the subject’s proper completion of the protocol requirement
2. History of life threatening asthma: Defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnea, respiratory arrest or hypoxic seizures within the last 6 months
3. A lower respiratory tract infection within 7 days of the screening visit.
4. Concurrent diagnosis of COPD or other respiratory disorders including active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases.
5. History of hypersensitivity/intolerance to any components of the study inhalers (e.g., 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.
6. Historical or current evidence of clinically significant or rapidly progressing or unstable cardiovascular, neurological, cardiovascular, neurological, renal, hepatic, immunological, endocrine (including uncontrolled diabetes or thyroid disease) or hematological abnormalities that are uncontrolled. Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subject at risk through participation, or which would affect the analysis if the disease/condition exacerbated during the study.
7. Patient who have ever received treatment with biological based therapy e.g. omalizumab, mepolizumab, for asthma
8. Subjects who have 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
9. A subject will not be eligible for this study if he/she is an immediate family member of the participating investigator, sub-investigator, study coordinator, employee of the participating investigator, or any family member of Propeller Health employee

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified