Status:
COMPLETED
Clinical Effects of Temperature Controlled Laminar Airflow (TLA)
Lead Sponsor:
Airsonett AB
Collaborating Sponsors:
Karolinska University Hospital
University Hospital, Linkoeping
Conditions:
Asthma
Perennial Allergy
Eligibility:
All Genders
12-28 years
Phase:
PHASE2
Brief Summary
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...
Detailed Description
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 w...
Eligibility Criteria
Inclusion
- 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
- Inclusion in another Allergen avoidance program.
- Smoking in the family
- Participation in a drug trial
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2006
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00987064
Start Date
October 1 2005
End Date
June 1 2006
Last Update
January 14 2015
Active Locations (2)
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1
University Hospital, Linkoeping
Linköping, Sweden, SE-581 91
2
Karolinska University Hospital
Stockholm, Sweden, SE-171 76