Laminar Airflow in Severe Asthma for Exacerbation Reduction (LASER)

Portsmouth Hospitals NHS Trust

Status

Completed

Conditions

Asthma

Treatments

Device: Temperature-Controlled Laminar Airflow Device (Airsonett®)

Study type

Interventional

Funder types

Other

Identifiers

NCT03058497

12/33/28

Details and patient eligibility

About

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.

Full description

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.

Enrollment

240 patients

Sex

All

Ages

16 to 75 years old

Volunteers

Accepts Healthy Volunteers

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