Status:
COMPLETED
Efficacy Study of Temperature Controlled Laminar Airflow (TLA)-Treatment in Perennial Allergic Asthma
Lead Sponsor:
Airsonett AB
Collaborating Sponsors:
Commitum AB
Croel AB
Conditions:
Asthma
Eligibility:
All Genders
7-70 years
Phase:
PHASE3
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...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
312 Patients enrolled
Trial Details
Trial ID
NCT00986323
Start Date
April 1 2008
End Date
February 1 2010
Last Update
November 9 2010
Active Locations (19)
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1
Aarhus University Hospital
Aarhus, Denmark
2
Bispebjerg Hospital
Copenhagen, Denmark
3
Turku Allergy Centre
Turku, Finland
4
Ruhr University of Bochum
Bochum, Germany