Effect of Temperature Controlled Laminar Airflow (TLA) on Nasal Airway Inflammation and Sleep Quality in Asthma

This study has been completed.
Sponsor:
Collaborators:
Croel AB
Commitum AB
Information provided by:
Airsonett AB
ClinicalTrials.gov Identifier:
NCT00986622
First received: September 29, 2009
Last updated: November 8, 2010
Last verified: November 2010
  Purpose

The purpose of this study is to determine whether clean air administered to the breathing zone with Temperature regulated Laminar Airflow (TLA) during night is effective as add on treatment in patients with perennial allergic asthma.


Condition Intervention Phase
Asthma
Device: Temperature controlled Laminar Airflow (TLA) - Protexo
Device: Placebo TLA
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of the Airsonett Airshower on Measures of Sleep Quality and Nasal Airway Inflammation

Resource links provided by NLM:


Further study details as provided by Airsonett AB:

Primary Outcome Measures:
  • Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) or Paediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) [ Time Frame: Week 0 and 52 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Peak nasal inspiratory flow measurement [ Time Frame: Week 0 and 52 ] [ Designated as safety issue: No ]
  • Subjective assessment of sleep quality using the Pediatric Sleep Questionnaire (PSQ). [ Time Frame: Week 0 and 52 ] [ Designated as safety issue: No ]
  • IL-4 in nasal secretions [ Time Frame: Week 0 and 52 ] [ Designated as safety issue: No ]
  • Objective assessment of sleep quality using Actigraphy to measure the sleep fragmentation index. [ Time Frame: Week 0 and 52 ] [ Designated as safety issue: No ]

Enrollment: 48
Study Start Date: June 2008
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Temeperature controlled Laminar Airflow
Active treatment with Temperature controlled Laminar Airflow (TLA).
Device: Temperature controlled Laminar Airflow (TLA) - Protexo
Nocturnal environmental control with Temperature controlled Laminar Airflow (TLA)
Other Name: Protexo
Placebo Comparator: Placebo TLA
Placebo TLA treatment
Device: Placebo TLA
Placebo TLA (without filtration and TLA function)

Detailed Description:

Exposure to inhaled allergens is a pathogenetic factor in allergic asthma. However, physical, chemical and combined methods aiming to reduce airborne allergen levels have shown little or no effect in reducing asthma symptoms in people who are sensitive to perennial allergens.

Aims and objectives: This study aims to investigate treatment with Temperature regulated Laminar Airflow (TLA) with a very low particle concentration directed to the breathing zone of subjects with allergic asthma during night sleep. The hypothesis is that the decreased allergen exposure during the night will have a positive effect on nasal airway inflammation and sleep quality in asthma. Measurements of Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ), Peak nasal inspiratory flow, sleep quality using the Pediatric Sleep Questionnaire (PSQ), IL-4 in nasal secretions, objective assessment of sleep quality using Actigraphy.

Method: This is a double blind, randomized 52 week parallel trial comparing active and placebo treatment with TLA. For ethical reasons the randomization is 2 to 1 for active and placebo treatment, respectively. A 2 weeks run-in period is inserted between inclusion and randomization. First 12 weeks an unchanged maintenance medication will be kept and week 13-52 medication will be modified to obtain asthma control according to international guidelines (GINA). After inclusion, run-in, randomization and baseline measurements active/placebo treatment with AA will be implemented over 52

  Eligibility

Ages Eligible for Study:   7 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Consent to participate voluntarily.
  • Willing and able to comply with the study specific procedures.
  • Signed Informed Consent prior to any study procedure.
  • Perennial allergic asthma
  • Age 7 through 70 years at time of randomization.
  • A miniAQLQ/PAQLQ score of ≤ 5.5.
  • Sensitive to pet allergen and/or house dust mites as demonstrated by changed to RAST 0.70 or positive skin prick test (wheal reaction similar to histamine control).
  • Daily maintenance dose of at least ICS >=200µg/day of budesonide or >=100µg/day of fluticasone since at least 6 months
  • Features of partly controlled asthma according to GINA

Exclusion Criteria:

  • Current smoker (Non-smoker is defined as abstinent since > 1 year). Children: Parents'indoor smoking.
  • Participation in another allergen avoidance program
  • Participation in drug trial the preceding 3 months
  • Multiple chemical sensitivity (e.g. paint, petrol, perfumes) as primary etiology
  • Allergen injection or sublingual treatment in the preceding 2 years
  • ICS ≥1200µg/day of budesonide or 1000µg/day of fluticasone
  • Significant cardiovascular disease
  • Participation in the present trial of a family member within the same household
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00986622

Locations
United Kingdom
Paediatric Research Unit, Imperial College, Praed Street,
London, United Kingdom, W2 1NY
Sponsors and Collaborators
Airsonett AB
Croel AB
Commitum AB
Investigators
Principal Investigator: John Warner, PhD, MD Paediatric Research Unit, Imperial College, London, UK
  More Information

No publications provided

Responsible Party: Professor John Warner, Chair in Paediatrics and Head of Department Paediatrics, Paediatric Research Unit, Imperial College, London, UK
ClinicalTrials.gov Identifier: NCT00986622     History of Changes
Other Study ID Numbers: Air 3-03-02, Main protocol Air 3-03 (4A)
Study First Received: September 29, 2009
Last Updated: November 8, 2010
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee

Keywords provided by Airsonett AB:
Temperature controlled Laminar Airflow
TLA
Protexo
Rhinoconjunctivitis Quality of Life Questionnaire
Perennial allergy
Inflammatory mediators
Quality of sleep
Nasal epithelial lining fluid
Environmental control

Additional relevant MeSH terms:
Asthma
Inflammation
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on September 18, 2014