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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Airsonett Airshower in Allergic Asthma a Double-blind Randomized Multi-centre Trial

Conditions
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Asthma

Intervention / Treatment
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* Device: Temperature controlled Laminar Airflow (TLA)
* Device: Placebo TLA


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Temeperature controlled Laminar Airflow<br>Active treatment with Temperature controlled Laminar Airflow (TLA) | Device: Temperature controlled Laminar Airflow (TLA)<br>* Nocturnal environmental control with Temperature controlled Laminar Airflow (TLA).<br>* Other names: TLA;|
| Placebo Comparator: Placebo TLA<br>Placebo TLA treatment | Device: Placebo TLA<br>* Placebo TLA (without filtration and TLA function)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| miniAQLQ (Mini Asthma Quality of Life Questionnaire, Appendix 1) and the corresponding paediatric PAQLQ score. |  | Week -2, 0, 4, 12, 24, 36 and 52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FENO (Nitric Oxide in Exhaled Air) |  | Week -2, 0, 4, 12, 24, 36 and 52 | 
| 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) |  | Week -2, 0, 4, 12, 24, 36 and 52 | 
| Rhinitis symptoms assessed by questionnaire |  | Week 0 and 52 | 
| RAST value and eosinophil count. |  | Week 0 and 52 | 
| Asthma Control Test (ACT). |  | Week -2, 0, 12, 24, 36 and 52 | 
| Resource consumption |  | Week 0, 4, 12, 24, 36 and 52 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthma, Temperature controlled Laminar Airflow, TLA, Perennial allergy, Quality of life, Environmental control