Clinical Effects of Temperature Controlled Laminar Airflow (TLA)

January 13, 2015 updated by: Airsonett AB

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Linkoeping, Sweden, SE-581 91
        • University Hospital, Linkoeping
      • Stockholm, Sweden, SE-171 76
        • Karolinska University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 28 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Protexo
PLACEBO_COMPARATOR: Placebo TLA
Placebo treatment with TLA (no filtration function)
Device: Placebo TLA
TLA treatment with disabled filtration function

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Quality of life assessed by mini Asthma Quality of Life Questionnaire (miniAQLQ)
Time Frame: Every 2 weeks of the study period
Every 2 weeks of the study period

Secondary Outcome Measures

Outcome Measure
Time Frame
Airway inflammation measurement assessed by Exhaled nitric oxide (FeNO)
Time Frame: Every 5 week of the study period
Every 5 week of the study period
Lung function (FeV1, PEF)
Time Frame: Every 5 week of the study period
Every 5 week of the study period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Airsonett AB

Collaborators

Karolinska University Hospital
Quintiles, Inc.
University Hospital, Linkoeping

Investigators

  • Principal Investigator: Christophe Pedroletti, MD, PhD., Karolinska University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Primary Completion (ACTUAL)

May 1, 2006

Study Completion (ACTUAL)

June 1, 2006

Study Registration Dates

First Submitted

September 28, 2009

First Submitted That Met QC Criteria

September 29, 2009

First Posted (ESTIMATE)

September 30, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

January 14, 2015

Last Update Submitted That Met QC Criteria

January 13, 2015

Last Verified

September 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Air 3-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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