The LASER Trial - 07730619850

A breath of fresh air in asthma - a clinical research trial of temperature controlled laminar airflow treatment for patients with poorly controlled asthma

Background and study aims:
Acute attacks of asthma (asthma exacerbations) are common and cause a great deal of suffering in asthmatic patients. Current treatments for asthma are not completely effective and new and better treatments are needed. We would like to test whether a new device that reduces the number of allergy particles in the air (which are known to cause asthma) can help reduce these asthma attacks and improve asthma patients’ quality of life. The device is known as a Temperature Controlled Laminar Airflow (TLA) device or Airsonett® device. The TLA device is installed in the participant’s bedroom and will automatically switch on each night. The machine filters the air, removing allergy particles from the patient’s breathing zone to allow the lungs to ‘rest’ overnight.

Who can participate?
Adults (aged 18-75) with severe, poorly-controlled asthma will be approached to take part in the study.

What does the study involve?
Initially participants will be invited to attend information events to hear what is involved with the study. Thereafter if participants are willing to take part they will be invited to attend a screening visit where various tests will be performed, including breathing, blood tests, allergy testing as well as completing several questionnaires. Half of the participants will be given a TLA machine that is working, and the other half will be given a machine 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 machine 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 machine in the participants home at the beginning of the study and will be available throughout the study period to deal with any queries. Participants will be in the study for 12 months, and will be asked to report their asthma attacks to the study team whenever they occur, in addition to visiting the study team 4 times over the 12 months to assess their asthma control and quality of life. At the end of the study all participants, regardless of their initial study group, will be offered the opportunity to keep a working machine in their home free of charge for a further four years.

What are the possible benefits and risks of participating?
By performing this study it is hoped it will improve the treatment of asthma in the future. There are no known risks associated with this treatment.

Where is the study run from?
The study is run by the Oxford Clinical Trials Unit (OCTRU), Oxford, UK.

When is the study starting and how long is it expected to run for?
The study opened in December 2013. Recruitment is starting in May 2014 with a recruitment period of 18 months. The study is expected to the last till end of 2016.

Who is funding the study?
The study is being funded by the National Institute for Health Research (NIHR), (UK).

Who is the main contact?
Dr Will Storrar