Efficacy Study of Temperature Controlled Laminar Airflow (TLA)-Treatment in Perennial Allergic Asthma (4A)

This study has been completed.
Sponsor:
Collaborators:
Commitum AB
Croel AB
Information provided by:
Airsonett AB
ClinicalTrials.gov Identifier:
NCT00986323
First received: September 27, 2009
Last updated: November 8, 2010
Last verified: November 2010

September 27, 2009
November 8, 2010
April 2008
February 2010   (final data collection date for primary outcome measure)
miniAQLQ (Mini Asthma Quality of Life Questionnaire, Appendix 1) and the corresponding paediatric PAQLQ score. [ Time Frame: Week -2, 0, 4, 12, 24, 36 and 52 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00986323 on ClinicalTrials.gov Archive Site
  • FENO (Nitric Oxide in Exhaled Air) [ Time Frame: Week -2, 0, 4, 12, 24, 36 and 52 ] [ Designated as safety issue: No ]
  • Lung function assessed by forced expiratory volume (FEV1), PEF (Expiratory peak flow) and FEF50 (Predicted Forced Expiratory Flow Rate at 50 Percent of Vital Capacity) [ Time Frame: Week -2, 0, 4, 12, 24, 36 and 52 ] [ Designated as safety issue: No ]
  • Rhinitis symptoms assessed by questionnaire [ Time Frame: Week 0 and 52 ] [ Designated as safety issue: No ]
  • RAST value and eosinophil count. [ Time Frame: Week 0 and 52 ] [ Designated as safety issue: No ]
  • Asthma Control Test (ACT). [ Time Frame: Week -2, 0, 12, 24, 36 and 52 ] [ Designated as safety issue: No ]
  • Resource consumption [ Time Frame: Week 0, 4, 12, 24, 36 and 52 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Efficacy Study of Temperature Controlled Laminar Airflow (TLA)-Treatment in Perennial Allergic Asthma
Airsonett Airshower in Allergic Asthma a Double-blind Randomized Multi-centre Trial

The purpose of this study is to determine whether nocturnal environmental control with Temperature controlled Laminar Airflow (TLA) 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 controled Laminar Airflow (TLA) with a very low particle concentration directed to the breathing zone in subjects with allergic asthma during night sleep. The hypothesis is that the decreased allergen exposure during the night will have an effect on quality of life and bronchial inflammation.

Method: This is a multicentre, double blind, randomized 52 week parallel trial comparing active TLA treatment with Placebo. 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, during which the patient shall get familiar with the use of the patient asthma diary and to adhere to the requirements of the study participation. 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 weeks.

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)
    Nocturnal environmental control with Temperature controlled Laminar Airflow (TLA).
    Other Names:
    • Protexo
    • TLA
  • 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)
  • Placebo Comparator: Placebo TLA
    Placebo TLA treatment
    Intervention: Device: Placebo TLA
Boyle RJ, Pedroletti C, Wickman M, Bjermer L, Valovirta E, Dahl R, Von Berg A, Zetterström O, Warner JO; 4A Study Group. Nocturnal temperature controlled laminar airflow for treating atopic asthma: a randomised controlled trial. Thorax. 2012 Mar;67(3):215-21. doi: 10.1136/thoraxjnl-2011-200665. Epub 2011 Nov 30.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
312
February 2010
February 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, male and female, 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

Other protocol-defined exclusion criteria may apply

Both
7 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Denmark,   Finland,   Germany,   Norway,   Sweden,   United Kingdom
 
NCT00986323
Air 3-03
Yes
Prof. Dr. Chris Anderson, Head of activity, University Hospital, Linkoeping, Sweden
Airsonett AB
  • Commitum AB
  • Croel AB
Principal Investigator: Olof Zetterström, MD, PhD. University Hospital, Linkoeping
Airsonett AB
November 2010

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