Clinical Effects of Temperature Controlled Laminar Airflow (TLA)

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00987064
• Other study ID #: Air 3-01
• Status: Completed
• Phase: Phase 2
• First received: September 28, 2009
• Last updated: January 13, 2015
• Start date: October 2005
• Est. completion date: June 2006

Study information

• Verified date: September 2009
• Source: Airsonett AB
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products AgencySweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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 allergic asthma.

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: June 2006
• Est. primary completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 28 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma
• Perennial Allergy

Intervention

Device:
• Temperature controlled Laminar Airflow (Protexo)
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.
• Placebo TLA
TLA treatment with disabled filtration function

Locations

Country	Name	City	State
Sweden	University Hospital, Linkoeping	Linkoeping
Sweden	Karolinska University Hospital	Stockholm

Sponsors (4)

Lead Sponsor	Collaborator
Airsonett AB	Karolinska University Hospital, Quintiles, Inc., University Hospital, Linkoeping

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

Pedroletti C, Millinger E, Dahlén B, Söderman P, Zetterström O. Clinical effects of purified air administered to the breathing zone in allergic asthma: A double-blind randomized cross-over trial. Respir Med. 2009 Sep;103(9):1313-9. doi: 10.1016/j.rmed.2009.03.020. Epub 2009 May 13. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life assessed by mini Asthma Quality of Life Questionnaire (miniAQLQ)		Every 2 weeks of the study period	No
Secondary	Airway inflammation measurement assessed by Exhaled nitric oxide (FeNO)		Every 5 week of the study period	No
Secondary	Lung function (FeV1, PEF)		Every 5 week of the study period	No