Laminar Airflow in Severe Asthma for Exacerbation Reduction

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Multi-centre Randomised, Double Blind, Placebo-controlled, Parallel Group Trial of the Effectiveness of the Nocturnal Use of a Temperature Controlled Laminar Airflow (TLA) Device (Airsonett®) in Adults With Poorly-controlled, Severe Allergic Asthma

Conditions
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Asthma

Intervention / Treatment
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* Device: Temperature-Controlled Laminar Airflow Device (Airsonett®)


Participation Criteria
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Eligibility Criteria
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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: Current smokers or ex-smokers abstinent for <6months Ex-smokers with ≥15 pack year smoking history Partner who is a current smoker and smokes within the bedroom where the TLA device is installed TLA device cannot be safely installed within the bedroom Intending to move out of study area within the follow-up period Documented poor treatment adherence Occupational asthma with continued exposure to known sensitising agents in the workplace Previous bronchial thermoplasty within 12 months of randomisation Treatment with Omalizumab (anti-IgE) within 120 days of randomisation Using long-term oxygen, Continuous Positive Airway Pressure (CPAP) or Non-Invasive Ventilation (NIV) Presence of clinically significant lung disease other than asthma, including smoking-related chronic obstructive pulmonary disease (COPD), bronchiectasis associated with recurrent bacterial infection, allergic bronchopulmonary aspergillosis (mycosis), pulmonary fibrosis, sleep apnoea, pulmonary hypertension, or lung cancer, Patients currently taking part in other interventional respiratory clinical trials

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Temperature-Controlled Laminar Airflow Device Active<br>Temperature-Controlled Laminar Airflow Device | Device: Temperature-Controlled Laminar Airflow Device (Airsonett®)<br> <br> |
| Placebo Comparator: Temperature-Controlled Laminar Airflow Device Placebo<br>Temperature-Controlled Laminar Airflow Device | Device: Temperature-Controlled Laminar Airflow Device (Airsonett®)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exacerbation frequency | The frequency of severe asthma exacerbations occurring within the 12 month follow-up | 12 months | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |