Clareo Health | A Clinical Study to Evaluate the Effect of the Connected Inhaler System (CIS) on Adherence to Maintenance Therapy in Poorly Controlled Asthmatic Subjects
A Clinical Study to Evaluate the Effect of the Connected Inhaler System (CIS) on Adherence to Maintenance Therapy in Poorly Controlled Asthmatic Subjects
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
GlaxoSmithKline
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Subjects aged 18 years or older, at the time of signing the informed consent.
Subjects with documented physician diagnosis of asthma as their primary respiratory disease.
ACT score \<20 at screening visit.
Non-smokers (never smoked or not smoking for \>6 months with \<10 pack years history (Pack years = \[cigarettes per day smoked/20\] multiplied by number of years smoked).
Male or female subjects will be included. A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: (i) Not a woman of childbearing potential (WOCBP). (ii) A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 5 days\] after the last dose of study treatment.
Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the consent form and protocol.
Subject understands and is willing, able, and likely to comply with study procedures and restrictions.
Subject must be able to read in a language supported by the smart phone app in their region.
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.
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.
Subject must have their own Android or iPhone operating system (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 1 megabyte (MB) per month as a maximum; this is less data than a 1 minute video streamed from YouTube (2MB).
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.
ACT score \<20 at randomization visit (visit 2).
You may not be if
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.
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 the 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.
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.
Subjects who have ever received treatment with biological based therapy example, omalizumab, mepolizumab, for asthma.
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.
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 a Propeller Health employee.
