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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02813811
Recruitment Status : Unknown
Verified July 2016 by Portsmouth Hospitals NHS Trust.
Recruitment status was:  Recruiting
First Posted : June 27, 2016
Last Update Posted : July 27, 2016
Sponsor:
Collaborator:
Airsonett AB
Information provided by (Responsible Party):
Portsmouth Hospitals NHS Trust

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.


Condition or disease
Asthma

Show Show detailed description

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Single Arm, Cohort Study of Nocturnal Temperature-controlled Laminar Airflow (TLA) Treatment (Airsonett®) in Patients With Allergic Asthma to Determine the Effect of Long-term Treatment on Exacerbation Frequency.
Study Start Date : May 2016
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma




Primary Outcome Measures :
  1. Frequency of severe asthma exacerbations over the 48-month follow up period. [ Time Frame: 48 months ]

    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.



Secondary Outcome Measures :
  1. Current asthma control [ Time Frame: 6, 12, 18, 24, 30, 36, 42 and 48 months ]

    Current asthma control will be recorded at 6, 12, 18, 24, 30, 36, 42 and 48 months.

    This will be measured using the Asthma Control Questionnaire.


  2. Exacerbation Frequency [ Time Frame: 48 months ]
    Risk of adverse asthma outcomes will be recorded over the 48 month study period at 6, 12, 18, 24, 30, 36, 42 and 48 months

  3. Oral Corticosteroid Use [ Time Frame: 6, 12, 18, 24, 30, 36, 42 and 48 months ]
    Risk of adverse asthma outcomes will be recorded over the 48 month study period at 6, 12, 18, 24, 30, 36, 42 and 48 months

  4. Frequency of Hospital Admissions for Asthma [ Time Frame: 6, 12, 18, 24, 30, 36, 42 and 48 months ]
    Risk of adverse asthma outcomes will be recorded over the 48 month study period at 6, 12, 18, 24, 30, 36, 42 and 48 months

  5. Health Related Quality of Life - Mini Asthma Quality of Life Questionnaire [ Time Frame: 6, 12, 18, 24, 30, 36, 42 and 48 months ]
    This will be measured using the mini Asthma Quality of Life Questionnaire (miniAQLQ) at 6, 12, 18, 24, 30, 36, 42 and 48 months.

  6. Health Related Quality of Life - EQ-5D-5L health questionnaire [ Time Frame: 6, 12, 18, 24, 30, 36, 42 and 48 months ]
    This will also be measured using the the EQ-5D-5L health questionnaire at 6, 12, 18, 24, 30, 36, 42 and 48 months.

  7. Sino-nasal Symptoms [ Time Frame: 6, 12, 18, 24, 30, 36, 42 and 48 months ]
    This will be measured using the SNOT-22 (Sino-Nasal Outcome Test questionnaire at 6, 12, 18, 24, 30, 36, 42 and 48 months.

  8. Health Economics [ Time Frame: 48 months ]
    Healthcare resource use and cost will be measured and participants will complete the Work Productivity and Activity Impairment (WPAI(A)) Questionnaire.

  9. TLA Treatment Acceptability [ Time Frame: 12, 24, 36 and 48 months ]
    Time to withdrawal of treatment and participants perception of the TLA device will be recorded at 12, 24, 36 and 48 months.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02813811


Contacts
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Contact: Prof Anoop J Chauhan, MB ChB, MRCP 02392 286000 ext 3360 anoop.chauhan@porthosp.nhs.uk
Contact: Lara Balls 02392 286000 ext 4108 lara.balls@porthosp.nhs.uk

Locations
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United Kingdom
Portsmouth Hospitals NHS Trust, Queen Alexandra Hospital Recruiting
Portsmouth, Hampshire, United Kingdom, PO6 3LY
Contact: Prof Anoop J Chauhan    02392 286000 ext 3360    anoop.chauhan@porthosp.nhs.uk   
Contact: Dr Alice Mortlock    02392 286000 ext 4042    alice.mortlock@porthosp.nhs.uk   
Sponsors and Collaborators
Portsmouth Hospitals NHS Trust
Airsonett AB
Investigators
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Principal Investigator: Prof Anoop J Chauhan, MB ChB, MRCP Consultant Respiratory Physician and Director of Research & Innovation
Additional Information:
Publications:

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Responsible Party: Portsmouth Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT02813811    
Other Study ID Numbers: PHT/2015/115
First Posted: June 27, 2016    Key Record Dates
Last Update Posted: July 27, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Portsmouth Hospitals NHS Trust:
Temperature-controlled Laminar Airflow
Exacerbation frequency
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases