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| Name | Class |
|---|---|
| University of Oxford | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Temperature-Controlled Laminar Airflow Device Active | Active Comparator | Temperature-Controlled Laminar Airflow Device |
|
| Temperature-Controlled Laminar Airflow Device Placebo | Placebo Comparator | Temperature-Controlled Laminar Airflow Device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Temperature-Controlled Laminar Airflow Device (Airsonett®) | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Exacerbation frequency | The frequency of severe asthma exacerbations occurring within the 12 month follow-up | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Asthma Control | • To assess the impact of nocturnal TLA treatment on asthma control which includes: Current clinical asthma control | 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 |
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Inclusion Criteria:
- A clinical diagnosis of asthma for ≥6 months with either: Airflow variability Airway reversibility Airway hyper-responsiveness
Requirement for high-dose inhaled corticosteroids (ICS) (≥1000μg/day beclomethasone (BDP) or equivalent
Poorly controlled asthma demonstrated by BOTH
≥2 severe asthma exacerbations, ACQ (7-point) score >1 at Screening Visit 1 and Randomisation Visit 2
Atopic status
Exacerbation free
Able to use the TLA device during sleep on at least five nights per week
Able to understand and give written informed consent prior
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anoop[ Chauhan | Portsmouth Hospitals NHS Trust | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Portsmouth Hospital NHS Trust | Portsmouth | UK | PO6 3LY | United Kingdom |
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| Label | URL |
|---|---|
| Trial Website | View source |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| 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. | 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 | 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 | 12 months |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |