To ascertain whether home-based nocturnal TLA usage over a 12 month period can reduce exacerbations and improve asthma control and quality of life as compared to placebo, whilst being cost-effective and acceptable to adults with poorly-controlled, severe allergic asthma.
We will include 222 adults, half of whom will be given a TLA device that is working, and the other half will be given a device which has been inactivated (the filtering process will be switched off, although the participants will not be able to tell that this has occurred). Which participant receives the working or deactivated device will be decided by a random process and will be unknown to the researcher and the participant. An engineering team from the manufacturer will install the device in the participants' home at the beginning of the study and be available throughout the study period to deal with any queries. All participants will continue receiving their usual treatments. Participants will be in the study for 12 months, and will report their asthma attacks to the trial team whenever they occur during this period. In addition, they will visit the trial team 4 times (after 3, 6, 9 and 12 months) to assess their asthma control and quality of life. At the end of the trial, we will invite participants at each site to join a group discussion where researchers will explore the participant's thoughts about the TLA device. At the end of their participation in the trial, all participants who have used the device for more than 6 months, regardless of their initial study group, will be offered the opportunity to keep an active device in their home free of charge for a further four years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
240
Portsmouth Hospital NHS Trust
Portsmouth, UK, United Kingdom
Exacerbation frequency
The frequency of severe asthma exacerbations occurring within the 12 month follow-up
Time frame: 12 months
Asthma Control
• To assess the impact of nocturnal TLA treatment on asthma control which includes: Current clinical asthma control
Time frame: 12 months
Treatment effect on quality of Life
• To ascertain the effect of TLA treatment on quality of life in poorly-controlled severe allergic asthmatic participants and their carers. This will be measured via patient questionnaires
Time frame: 12 months
Evaluate the device
• To qualitatively evaluate the perceptions, values and opinions of the device to identify potential modifications to improve patient acceptance and to inform future implementation of the device within the NHS setting This will be measured by the participants usage via a completed diary over the 12m period.
Time frame: 12 months
NHS Costs
To evaluate the impact of TLA treatment on healthcare utilisation and related costs, and its impact on education/work days lost
Time frame: 12 months
NHS Costs
To fully assess the cost-effectiveness, both at one-year and over the lifetime of the patient, of nocturnal TLA treatment using a cost-utility analysis to determine the incremental cost per QALY gained
Time frame: 12 months
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