NCT03058497

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for not_applicable asthma

Timeline
Completed

Started May 2014

Typical duration for not_applicable asthma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

January 6, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 23, 2017

Completed
Last Updated

February 23, 2017

Status Verified

February 1, 2017

Enrollment Period

2.7 years

First QC Date

January 6, 2017

Last Update Submit

February 20, 2017

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

  • Exacerbation frequency

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

    12 months

Secondary Outcomes (5)

  • Asthma Control

    12 months

  • Treatment effect on quality of Life

    12 months

  • Evaluate the device

    12 months

  • NHS Costs

    12 months

  • NHS Costs

    12 months

Study Arms (2)

Temperature-Controlled Laminar Airflow Device Active

ACTIVE COMPARATOR

Temperature-Controlled Laminar Airflow Device

Device: Temperature-Controlled Laminar Airflow Device (Airsonett®)

Temperature-Controlled Laminar Airflow Device Placebo

PLACEBO COMPARATOR

Temperature-Controlled Laminar Airflow Device

Device: Temperature-Controlled Laminar Airflow Device (Airsonett®)

Interventions

Temperature-Controlled Laminar Airflow Device (Airsonett®)DEVICE
Temperature-Controlled Laminar Airflow Device ActiveTemperature-Controlled Laminar Airflow Device Placebo

Eligibility Criteria

Age16 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • \- 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Portsmouth Hospital NHS Trust

Portsmouth, UK, PO6 3LY, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Anoop[ Chauhan

    Portsmouth Hospitals NHS Trust

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2017

First Posted

February 23, 2017

Study Start

May 1, 2014

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

February 23, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)