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Laminar Airflow in Severe Asthma for Exacerbation Reduction (LASER)

Primary Purpose

Asthma

Status

Completed

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

Temperature-Controlled Laminar Airflow Device (Airsonett®)

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

16 Years - 75 Years (Child, Adult, Older Adult)All SexesAccepts 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

Sites / Locations

Portsmouth Hospital NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Temperature-Controlled Laminar Airflow Device Active

Temperature-Controlled Laminar Airflow Device Placebo

Arm Description

Temperature-Controlled Laminar Airflow Device

Outcomes

Primary Outcome Measures

Exacerbation frequency

The frequency of severe asthma exacerbations occurring within the 12 month follow-up

Secondary Outcome Measures

Asthma Control

• To assess the impact of nocturnal TLA treatment on asthma control which includes: Current clinical asthma control

Treatment effect on quality of Life

• To ascertain the effect of TLA treatment on quality of life in poorly-controlled severe allergic asthmatic participants and their carers. This will be measured via patient questionnaires

Evaluate the device

• To qualitatively evaluate the perceptions, values and opinions of the device to identify potential modifications to improve patient acceptance and to inform future implementation of the device within the NHS setting This will be measured by the participants usage via a completed diary over the 12m period.

NHS Costs

To evaluate the impact of TLA treatment on healthcare utilisation and related costs, and its impact on education/work days lost

NHS Costs

To fully assess the cost-effectiveness, both at one-year and over the lifetime of the patient, of nocturnal TLA treatment using a cost-utility analysis to determine the incremental cost per QALY gained

Full Information

NCT ID

NCT03058497

First Posted

January 6, 2017

Last Updated

February 20, 2017

Sponsor

Portsmouth Hospitals NHS Trust

Collaborators

University of Oxford

1. Study Identification

Unique Protocol Identification Number

NCT03058497

Brief Title

Laminar Airflow in Severe Asthma for Exacerbation Reduction

Acronym

LASER

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Completed

Study Start Date

May 2014 (undefined)

Primary Completion Date

January 2017 (Actual)

Study Completion Date

January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Portsmouth Hospitals NHS Trust

Collaborators

University of Oxford

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

240 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Temperature-Controlled Laminar Airflow Device Active

Arm Type

Active Comparator

Arm Description

Temperature-Controlled Laminar Airflow Device

Arm Title

Temperature-Controlled Laminar Airflow Device Placebo

Arm Type

Placebo Comparator

Arm Description

Temperature-Controlled Laminar Airflow Device

Intervention Type

Device

Intervention Name(s)

Temperature-Controlled Laminar Airflow Device (Airsonett®)

Primary Outcome Measure Information:

Title

Exacerbation frequency

Description

The frequency of severe asthma exacerbations occurring within the 12 month follow-up

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Asthma Control

Description

• To assess the impact of nocturnal TLA treatment on asthma control which includes: Current clinical asthma control

Time Frame

12 months

Title

Treatment effect on quality of Life

Description

• To ascertain the effect of TLA treatment on quality of life in poorly-controlled severe allergic asthmatic participants and their carers. This will be measured via patient questionnaires

Time Frame

12 months

Title

Evaluate the device

Description

Time Frame

12 months

Title

NHS Costs

Description

To evaluate the impact of TLA treatment on healthcare utilisation and related costs, and its impact on education/work days lost

Time Frame

12 months

Title

NHS Costs

Description

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Anoop[ Chauhan

Organizational Affiliation

Portsmouth Hospitals NHS Trust

Official's Role

Study Chair

Facility Information:

Facility Name

Portsmouth Hospital NHS Trust

City

Portsmouth

State/Province

ZIP/Postal Code

PO6 3LY

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Links:

URL

http://www.asthma-treatment.org.uk/

Description

Trial Website

Learn more about this trial

Laminar Airflow in Severe Asthma for Exacerbation Reduction

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