Laminar Airflow in Severe Asthma for Exacerbation Reduction - 48 Month Follow-up.

NCT02813811 | Completed

• 1 other identifier: PHT/2015/115
• Study Type: observational
• Target: 77
• Locations: 1 country
• Sites: 1

Brief Summary

Temperature-controlled Laminar Airflow (TLA) treatment delivered by the Airsonett treatment device is a new treatment for patients with allergic asthma. The LASER Trial (temperature-controlled Laminar Airflow in Severe asthma for Exacerbation Reduction - LASER) is a trial, currently evaluating whether the Airsonett device is able to reduce the frequency of asthma attacks in patients with allergic asthma. (www.lasertrial.co.uk) Participants who successfully complete at least 6 months of follow-up in the LASER trial are eligible for the post trial provision of 4 years of an active TLA treatment device. To date there is no long term performance data available to show whether there is any sustained benefit from the long term use of the Airsonett device, whether any improvement in asthma control or quality of life is maintained and whether patients will continue to use the treatment device beyond 12 months (the length of the longest previous trials of TLA treatment.) The investigators plan to assess the performance of the Airsonett device by recording the frequency of asthma attacks in patients over a 4-year period (48 months.) The investigators also wish to evaluate the effect of long term TLA treatment on asthma control, quality of life, healthcare resource use and patient acceptability of longer term use of the Airsonett device. Participants will be sent and asked to complete a series of questionnaires on a 6 monthly basis over the 48 month study period. Questionnaires will be returned by post to a single study centre based in Portsmouth, UK. Participants will also be contacted by telephone on a 6 monthly basis by a member of the trial team to collect information about their medication, healthcare resource use and whether they have had any asthma attacks since their last contact. Participants will not be expected to visit the study centre during the trial.

Conditions

Asthma

Keywords

Temperature-controlled Laminar Airflow; Exacerbation frequency

Outcome Measures

Primary Outcomes (1)

• Frequency of severe asthma exacerbations over the 48-month follow up period.

  Severe asthma exacerbations are defined in accordance with ATS/ERS guidelines as a worsening of asthma requiring systemic corticosteroids, ≥30mg prednisolone or equivalent daily (or ≥50% increase in dose if maintenance 30mg prednisolone or above) for 3 or more days. Courses of corticosteroids separated by ≥7 days will be treated as separate severe exacerbations. Participants will keep a record of their asthma exacerbations. They will be asked to record systemic corticosteroid use, dose of systemic corticosteroids and length of treatment course. This information will be collected from participants at 6, 12, 18, 24, 30, 36, 42 and 48 months.

  48 months

Secondary Outcomes (9)

• Current asthma control

  6, 12, 18, 24, 30, 36, 42 and 48 months

• Exacerbation Frequency

  48 months

• Oral Corticosteroid Use

  6, 12, 18, 24, 30, 36, 42 and 48 months

• Frequency of Hospital Admissions for Asthma

  6, 12, 18, 24, 30, 36, 42 and 48 months

• Health Related Quality of Life - Mini Asthma Quality of Life Questionnaire

  6, 12, 18, 24, 30, 36, 42 and 48 months

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

3 populations of adults (aged ≥16yrs) with allergic asthma will be invited to participate: 1. Patients receiving TLA treatment as part of the 4-year post trial provision period following participation in The LASER Trial where they were in the active treatment study group. 2. Patients receiving TLA treatment as part of the 4-year post trial provision period following participation in The LASER Trial where they were in the placebo treatment study group. 3. Patients starting TLA treatment for asthma who did not participate in The LASER Trial.

You may qualify if:

• The participant must meet ALL of the following criteria to be considered eligible for the study:
• Male or Female, aged 16 years or above.
• Using the TLA treatment device, Airsonett®, for the treatment of asthma.
• Participant is willing and able to give informed consent for participation in the study.

You may not qualify if:

• The participant may not enter the study if ANY of the following apply:
• Unable to comprehend the study and provide informed consent, e.g. insufficient command of English in the absence of someone to adequately interpret.

Sponsors & Collaborators

• Portsmouth Hospitals NHS Trust: lead
• Airsonett AB: collaborator

Study Sites (1)

Portsmouth Hospitals NHS Trust, Queen Alexandra Hospital

Portsmouth, Hampshire, PO6 3LY, United Kingdom

Location

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Related Links

• Outcomes Statergy for COPD and Asthma in England (2011) - Department of Health

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Prof Anoop J Chauhan, MB ChB, MRCP

  Consultant Respiratory Physician and Director of Research & Innovation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2016
• First Posted: June 27, 2016
• Study Start: May 24, 2016
• Primary Completion: February 17, 2021
• Study Completion: February 17, 2021
• Last Updated: September 30, 2022

Record last verified: 2022-09

Locations

GB (1)