Effect of Temperature Controlled Laminar Airflow (TLA) on Nasal Airway Inflammation and Sleep Quality in Asthma

• 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 ]

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

• 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

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

• Croel AB
• Commitum AB