Clinical trial NCT00986323: Efficacy Study of Temperature Controlled Laminar Airflow (TLA)-Treatment in Perennial Allergic Asthma
Official title: Airsonett Airshower in Allergic Asthma a Double-blind Randomized Multi-centre Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Keywords: Asthma
Temperature controlled Laminar Airflow
TLA
Perennial allergy
Quality of life
Environmental control
Lead sponsor: Airsonett AB
Sponsor class: INDUSTRY
Collaborators: name: Commitum AB
name: Croel AB
First posted: 2009-09-29
Enrollment: 312
Sex: ALL
Minimum age (years): 7
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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.

Eligibility 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, 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

Primary outcomes:
measure: miniAQLQ (Mini Asthma Quality of Life Questionnaire, Appendix 1) and the corresponding paediatric PAQLQ score.
timeFrame: Week -2, 0, 4, 12, 24, 36 and 52
Secondary outcomes:
measure: FENO (Nitric Oxide in Exhaled Air)
timeFrame: Week -2, 0, 4, 12, 24, 36 and 52
measure: 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)
timeFrame: Week -2, 0, 4, 12, 24, 36 and 52
measure: Rhinitis symptoms assessed by questionnaire
timeFrame: Week 0 and 52
measure: RAST value and eosinophil count.
timeFrame: Week 0 and 52
measure: Asthma Control Test (ACT).
timeFrame: Week -2, 0, 12, 24, 36 and 52
measure: Resource consumption
timeFrame: Week 0, 4, 12, 24, 36 and 52
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital
city: Turku
country: Finland
facility: Turku Allergy Centre
city: Bochum
country: Germany
facility: Ruhr University of Bochum
city: München
country: Germany
facility: University of München
city: Rostock
country: Germany
facility: University of Rostock
city: Wesel
country: Germany
facility: Marien Hospital Wesel
city: Oslo
country: Norway
facility: Ullevaal University Hospital
city: Trondheim
country: Norway
facility: St. Olavs Hospital
city: Angelholm
country: Sweden
facility: Ängelholm Hospital
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital, Sweden
city: Jonkoping
country: Sweden
facility: Jonkoping County Hospital
city: Karlstad
country: Sweden
facility: County Council of Värmland
city: Linkoeping
country: Sweden
facility: University Hospital, Linkoeping
city: Lund
country: Sweden
facility: Lund University Hospital
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
city: Stockholm
country: Sweden
facility: S:t Görans Hospital, Sweden
city: Stockholm
country: Sweden
facility: Stockholm South General Hospital
city: London
country: United Kingdom
facility: Imperial College London
Study officials:
affiliation: University Hospital, Linkoeping
name: Olof Zetterström, MD, PhD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Boyle RJ, Pedroletti C, Wickman M, Bjermer L, Valovirta E, Dahl R, Von Berg A, Zetterstrom 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.