Clinical Effects of Temperature Controlled Laminar Airflow (TLA)

NCT ID: NCT00987064

Last Updated: 2015-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-10-31
• Study Completion Date: 2006-06-30

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 allergic asthma.

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 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.

Conditions

Asthma; Perennial Allergy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Temperature controlled Laminar Airflow

Active treatment with Temperature controlled Laminar Airflow (TLA)

Group Type: ACTIVE_COMPARATOR

Temperature controlled Laminar Airflow (Protexo)

Intervention Type: DEVICE

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

Placebo treatment with TLA (no filtration function)

Group Type: PLACEBO_COMPARATOR

Placebo TLA

Intervention Type: DEVICE

TLA treatment with disabled filtration function

Interventions

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.

Intervention Type: DEVICE

Placebo TLA

TLA treatment with disabled filtration function

Intervention Type: DEVICE

Other Intervention Names

Protexo

Eligibility Criteria

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 28 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Karolinska University Hospital

OTHER

Sponsor Role: collaborator

University Hospital, Linkoeping

OTHER

Sponsor Role: collaborator

Quintiles, Inc.

INDUSTRY

Sponsor Role: collaborator

Airsonett AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Karolinska Universitety hospital Solna Sweden

Principal Investigators

Christophe Pedroletti, MD, PhD.

Role: PRINCIPAL_INVESTIGATOR

Karolinska University Hospital

Locations

University Hospital, Linkoeping

Linköping, , Sweden

Karolinska University Hospital

Stockholm, , Sweden

Countries

Sweden

References

Pedroletti C, Millinger E, Dahlen B, Soderman P, Zetterstrom 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.

Reference Type: BACKGROUND

PMID: 19443189 (View on PubMed)

Other Identifiers

Air 3-01

Identifier Type: -

Identifier Source: org_study_id