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Completed

NCT Number: NCT00987064

Clinical Effects of Temperature Controlled Laminar Airflow (TLA)

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Perennial Allergy Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

12 year–28 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University Hospital, Linkoeping, Linköping, Sweden

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Temperature controlled Laminar Airflow (Protexo)

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.

Other names: Protexo

Placebo TLA

Device

TLA treatment with disabled filtration function

Primary outcomes

  1. Quality of life assessed by mini Asthma Quality of Life Questionnaire (miniAQLQ)

    Time frame: Every 2 weeks of the study period

Secondary outcomes

  1. Airway inflammation measurement assessed by Exhaled nitric oxide (FeNO)

    Time frame: Every 5 week of the study period

  2. Lung function (FeV1, PEF)

    Time frame: Every 5 week of the study period

Sponsors and collaborators

Lead sponsor

Airsonett AB

Industry

Collaborators

  • Karolinska University Hospital
  • Quintiles, Inc.
  • University Hospital, Linkoeping

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Sep 30, 2009
Registry last updated
Jan 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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