Clinical Effects of Temperature Controlled Laminar Airflow (TLA)

Study Overview
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Brief Summary
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The purpose of this study is to determine whether clean air administered to the breathing zone with Temperature controlled Laminar Airflow (TLA) during night is effective in the treatment of perennial allergic asthma.

Detailed Description
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Background: Exposure to inhaled allergens is a pathogenetic factor in allergic asthma. However, most studies that previously looked at air cleaning devices have shown little or no effect on patients with perennial allergic asthma. Aims and objectives: This study aims to investigate a novel treatment, TLA, using temperature controlled laminar airflow with a very low particle concentration directed to the breathing zone of teenagers and adults with allergic asthma during night sleep. The hypothesis is that the decreased allergen exposure during the night will have an effect on bronchial inflammation and quality of life. Method: Patients are randomized to start with active or placebo treatment for 10 weeks. All patients receive both active and placebo treatment with unfiltered air, with a 2-week wash-out period in between treatments. Maintenance treatment with inhaled corticosteroids is unaltered during the trial period. Health related quality of life (miniAQLQ)is the primary effectiveness measure. Exhaled nitric oxide (FeNO) and spirometry are also investigated.

Official Title
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Clinical Effects of Purified Air Administered to the Breathing Zone in Allergic Asthma

Conditions
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Asthma, Perennial Allergy

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed for asthma for more than 1 year. More than 12% reactivity in FEV1 on bronchodilating medication or less than 90% of the FEV1 reference value according to Hedenström. Perennial allergy At least 3-mm wheal reaction in a skin prick test to at least one of following: House dust, Mold spores, dust mites, animal hair and dander. Little or no reactivity to other inhalant allergens. No known allergy to another inhalant allergen or chemical to which there is exposure in winter time. No allergen injection treatment in the preceding 2 years. A history of a requirement for daily medication for asthma including; 400µg steroid medication (Pulmicort or equal) for children and 800µg for adults. Beta agonist treatment on less than 4 days per week. Willingness to follow the clinical trial protocol, including medications, baseline and follow-up visits and procedures. Exclusion Criteria: Inclusion in another Allergen avoidance program. Smoking in the family Participation in a drug trial

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 28 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: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Temperature controlled Laminar Airflow<br>Active treatment with Temperature controlled Laminar Airflow (TLA) | Device: Temperature controlled Laminar Airflow (Protexo)<br>* The intervention is designed to reduce the allergen load in the patients breathing zone by vertically displacing the allergens, originating from the bed and the ambient room environment, with a temperature controlled laminar airflow (TLA) during night sleep. The airflow is filtered through a high efficiency particulate air filter(HEPA), slightly cooled and ''showered'' over the subject. Due to the higher density, the cooled air descends slowly, and displaces the allergens from the breathing zone.<br>* Other names: Protexo;|
| Placebo Comparator: Placebo TLA<br>Placebo treatment with TLA (no filtration function) | Device: Placebo TLA<br>* TLA treatment with disabled filtration function<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life assessed by mini Asthma Quality of Life Questionnaire (miniAQLQ) |  | Every 2 weeks of the study period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Airway inflammation measurement assessed by Exhaled nitric oxide (FeNO) |  | Every 5 week of the study period | 
| Lung function (FeV1, PEF) |  | Every 5 week of the study period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Protexo, Asthma, Temperature controlled Laminar Airflow, Perennial allergy, Quality of life, MiniAQLQ, FeNO, FEV1, PEF