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

Queen Alexandra Hospital (UK)0 sites240 target enrollmentJanuary 22, 2014

Overview

Registry

who.int

Start Date

January 22, 2014

End Date

July 1, 2018

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Sponsor

Queen Alexandra Hospital (UK)

•Current inclusion criteria as of 24/07/2015:
•1\. Adults (aged 16\-75 years inclusive)
•2\. A clinical diagnosis of asthma for \=6 months supported by evidence of any one of the following:
•2\.1\. Airflow variability with a mean diurnal peak expiratory flow (PEF) variability \>15% during the baseline 2\-week period or a variability in FEV1 of \>20% across clinic visits within the preceding 12 months, with concomitant evidence of airflow obstruction (FEV1/FVC ratio \<70%);
•2\.2\. Airway reversibility with an improvement in FEV1 by \=12% or 200 ml after inhalation of 400 µg of salbutamol via a metered dose inhaler and spacer at first study visit or within the preceding 12 months;
•2\.3\. Airway hyper\-responsiveness demonstrated by Methacholine challenge testing with a provocative concentration of Methacholine required to cause a 20% reduction in FEV1 (PC20\) of \=8mg/ml or equivalent test (See Appendix 3\).
•3\. Severe asthma:
•3\.1\. Requirement for high\-dose inhaled corticosteroids (ICS) (\=1000µg/day beclomethasone (BDP) or equivalent – see Appendix 4\) plus a second controller (long\-acting ß2\-agonist or anti\-muscarinic, theophylline, or leukotriene antagonist), and/or systemic corticosteroids.
•3\.2\. If on maintenance corticosteroids, the maintenance dose must have been stable for 3\-months– this excludes any interim need for short\-term steroid bursts to treat exacerbations.
•4\. Poorly controlled asthma demonstrated by BOTH:

•1\. Current smokers or ex\-smokers abstinent for \<6 months
•2\. Ex\-smokers with \=15 pack year smoking history
•3\. Partner who is a current smoker and smokes within the bedroom where the TLA device is installed
•4\. TLA device cannot be safely installed within the bedroom, intending to move out of study area within the trial period or unable to use the TLA device for at least 8 hours on at least 5 nights per week
•5\. Documented poor treatment adherence
•6\. Occupational asthma with continued exposure to known sensitising agents in the workplace
•7\. Previous bronchial thermoplasty within 12 months
•8\. Maintenance treatment with Omalizumab (anti\-IgE) within 3 months
•9\. Using long\-term oxygen, Continuous Positive Airway Pressure (CPAP) or Non\-Invasive Ventilation (NIV) routinely overnight as this will impair the effect of the TLA device
•10\. Uncontrolled symptomatic gastro\-oesophageal reflux that may act as a persistent asthma trigger