Clinical Effects of Temperature Controlled Laminar Airflow (TLA)

This study has been completed.
Sponsor:
Collaborators:
Karolinska University Hospital
University Hospital, Linkoeping
Quintiles
Information provided by:
Airsonett AB
ClinicalTrials.gov Identifier:
NCT00987064
First received: September 28, 2009
Last updated: September 29, 2009
Last verified: September 2009
  Purpose

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.


Condition Intervention Phase
Asthma
Perennial Allergy
Device: Temperature controlled Laminar Airflow (Protexo)
Device: Placebo TLA
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Effects of Purified Air Administered to the Breathing Zone in Allergic Asthma

Resource links provided by NLM:


Further study details as provided by Airsonett AB:

Primary Outcome Measures:
  • Quality of life assessed by mini Asthma Quality of Life Questionnaire (miniAQLQ) [ Time Frame: Every 2 weeks of the study period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Airway inflammation measurement assessed by Exhaled nitric oxide (FeNO) [ Time Frame: Every 5 week of the study period ] [ Designated as safety issue: No ]
  • Lung function (FeV1, PEF) [ Time Frame: Every 5 week of the study period ] [ Designated as safety issue: No ]

Enrollment: 28
Study Start Date: October 2005
Study Completion Date: June 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Temperature controlled Laminar Airflow
Active treatment with Temperature controlled Laminar Airflow (TLA)
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.
Other Name: Protexo
Placebo Comparator: Placebo TLA
Placebo treatment with TLA (no filtration function)
Device: Placebo TLA
TLA treatment with disabled filtration function

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.

  Eligibility

Ages Eligible for Study:   12 Years to 28 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00987064

Locations
Sweden
University Hospital, Linkoeping
Linkoeping, Sweden, SE-581 91
Karolinska University Hospital
Stockholm, Sweden, SE-171 76
Sponsors and Collaborators
Airsonett AB
Karolinska University Hospital
University Hospital, Linkoeping
Quintiles
Investigators
Principal Investigator: Christophe Pedroletti, MD, PhD. Karolinska University Hospital
  More Information

Publications:
Responsible Party: Prof. Dr. Gunilla Hedlin, Head of Activity, Karolinska Universitety hospital Solna Sweden
ClinicalTrials.gov Identifier: NCT00987064     History of Changes
Other Study ID Numbers: Air 3-01
Study First Received: September 28, 2009
Last Updated: September 29, 2009
Health Authority: Sweden: Medical Products Agency
Sweden: Regional Ethical Review Board

Keywords provided by Airsonett AB:
Protexo
Asthma
Temperature controlled Laminar Airflow
Perennial allergy
Quality of life
MiniAQLQ
FeNO
FEV1
PEF

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on October 16, 2014