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

September 29, 2009
November 8, 2010
June 2008
April 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00986622 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Effect of Temperature Controlled Laminar Airflow (TLA) on Nasal Airway Inflammation and Sleep Quality in Asthma
Effects of the Airsonett Airshower on Measures of Sleep Quality and Nasal Airway Inflammation

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.

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

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Asthma
  • Device: Temperature controlled Laminar Airflow (TLA) - Protexo
    Nocturnal environmental control with Temperature controlled Laminar Airflow (TLA)
    Other Name: Protexo
  • Device: Placebo TLA
    Placebo TLA (without filtration and TLA function)
  • Active Comparator: Temeperature controlled Laminar Airflow
    Active treatment with Temperature controlled Laminar Airflow (TLA).
    Intervention: Device: Temperature controlled Laminar Airflow (TLA) - Protexo
  • Placebo Comparator: Placebo TLA
    Placebo TLA treatment
    Intervention: Device: Placebo TLA
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
April 2010
April 2010   (final data collection date for primary outcome measure)

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
Both
7 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00986622
Air 3-03-02, Main protocol Air 3-03 (4A)
Yes
Professor John Warner, Chair in Paediatrics and Head of Department Paediatrics, Paediatric Research Unit, Imperial College, London, UK
Airsonett AB
  • Croel AB
  • Commitum AB
Principal Investigator: John Warner, PhD, MD Paediatric Research Unit, Imperial College, London, UK
Airsonett AB
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP