AsthmaLASERNCT03058497
Laminar Airflow in Severe Asthma for Exacerbation Reduction
A study of Asthma, run by Portsmouth Hospitals NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2014to Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 75 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Portsmouth Hospital NHS Trust
Portsmouth, UK, PO6 3LY
About this study
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
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.
Read the 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.
- Conditions
- Asthma
- Being tested
- Temperature-Controlled Laminar Airflow Device (Airsonett®)
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Temperature-Controlled Laminar Airflow Device (Airsonett®)Device
| Study group | Role | What they receive |
|---|---|---|
| Temperature-Controlled Laminar Airflow Device Active | Active comparator | Temperature-Controlled Laminar Airflow Device Receives: Device: Temperature-Controlled Laminar Airflow Device (Airsonett®) |
| Temperature-Controlled Laminar Airflow Device Placebo | Placebo comparator | Temperature-Controlled Laminar Airflow Device Receives: Device: Temperature-Controlled Laminar Airflow Device (Airsonett®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exacerbation frequency
The frequency of severe asthma exacerbations occurring within the 12 month follow-up
Measured: 12 months
Secondary outcomes (5)
Asthma Control
- To assess the impact of nocturnal TLA treatment on asthma control which includes: Current clinical asthma control
Measured: 12 months
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
Measured: 12 months
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.
Measured: 12 months
NHS Costs
To evaluate the impact of TLA treatment on healthcare utilisation and related costs, and its impact on education/work days lost
Measured: 12 months
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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study startMay 2014
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Portsmouth Hospitals NHS Trust
- Sponsor type
- Other government
- Collaborators
- University of Oxford
- Responsible party
- Sponsor
- Investigators
- Anoop[ Chauhan, Study chair, Portsmouth Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03058497
- Sponsor's protocol ID
- 12/33/28
- Acronym
- LASER
- Status last verified
- Feb 2017
- First submitted
- 6 Jan 2017
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03058497
- Acronym / sponsor ID
- LASER / 12/33/28
- Conditions
- Asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Portsmouth Hospitals NHS TrustOther government
- Collaborators
- University of Oxford
- Study start
- May 2014
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 23 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Temperature-Controlled Laminar Airflow Device Active | Active comparator | Device: Temperature-Controlled Laminar Airflow Device (Airsonett®)Temperature-Controlled Laminar Airflow Device |
| Temperature-Controlled Laminar Airflow Device Placebo | Placebo comparator | Device: Temperature-Controlled Laminar Airflow Device (Airsonett®)Temperature-Controlled Laminar Airflow Device |
Who may qualify
- Ages
- 16 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Temperature-Controlled Laminar Airflow Device (Airsonett®) | Device | Temperature-Controlled Laminar Airflow Device Active, Temperature-Controlled Laminar Airflow Device Placebo |
Primary outcome
Exacerbation frequency
Time frame: 12 months
The frequency of severe asthma exacerbations occurring within the 12 month follow-up
5 secondary outcomes
Asthma Control
Time frame: 12 months
Treatment effect on quality of Life
Time frame: 12 months
Evaluate the device
Time frame: 12 months
NHS Costs
Time frame: 12 months
NHS Costs
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
- Trial WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anoop[ Chauhan study chair
Portsmouth Hospitals NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Asthma, run by Portsmouth Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exacerbation frequency (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2017.