Efficacy Study of Temperature Controlled Laminar Airflow (TLA)-Treatment in Perennial Allergic Asthma (4A)

November 8, 2010 updated by: Airsonett AB

Airsonett Airshower in Allergic Asthma a Double-blind Randomized Multi-centre Trial

The purpose of this study is to determine whether nocturnal environmental control with Temperature controlled Laminar Airflow (TLA) is effective as add on treatment in patients with perennial allergic asthma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Exposure to inhaled allergens is a pathogenetic factor in allergic asthma. However, physical, chemical and combined methods aiming to reduce airborne allergen levels have shown little or no effect in reducing asthma symptoms in people who are sensitive to perennial allergens.Aims and objectives: This study aims to investigate treatment with Temperature controled Laminar Airflow (TLA) with a very low particle concentration directed to the breathing zone in subjects with allergic asthma during night sleep. The hypothesis is that the decreased allergen exposure during the night will have an effect on quality of life and bronchial inflammation.

Method: This is a multicentre, double blind, randomized 52 week parallel trial comparing active TLA treatment with Placebo. For ethical reasons the randomization is 2 to 1 for active and placebo treatment, respectively. A 2 weeks run-in period is inserted between inclusion and randomization, during which the patient shall get familiar with the use of the patient asthma diary and to adhere to the requirements of the study participation. First 12 weeks an unchanged maintenance medication will be kept and week 13-52 medication will be modified to obtain asthma control according to international guidelines (GINA). After inclusion, run-in, randomization and baseline measurements active/placebo treatment with AA will be implemented over 52 weeks.

Study Type

Interventional

Enrollment (Actual)

312

Phase

  • Phase 3

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

  • Denmark
      • Aarhus, Denmark
        • Aarhus University Hospital
      • Copenhagen, Denmark
        • Bispebjerg Hospital
  • Finland
      • Turku, Finland
        • Turku Allergy Centre
  • Germany
      • Bochum, Germany
        • Ruhr University of Bochum
      • München, Germany
        • University of München
      • Rostock, Germany
        • University of Rostock
      • Wesel, Germany
        • Marien Hospital Wesel
  • Norway
      • Oslo, Norway
        • Ullevaal University Hospital
      • Trondheim, Norway
        • St. Olavs Hospital
  • Sweden
      • Angelholm, Sweden
        • Ängelholm Hospital
      • Gothenburg, Sweden
        • Sahlgrenska University Hospital, Sweden
      • Jonkoping, Sweden
        • Jonkoping County Hospital
      • Karlstad, Sweden
        • County Council of Värmland
      • Linkoeping, Sweden
        • University Hospital, Linkoeping
      • Lund, Sweden
        • Lund University Hospital
      • Stockholm, Sweden
        • Stockholm South General Hospital
      • Stockholm, Sweden, SE-171 76
        • Karolinska University Hospital
      • Stockholm, Sweden
        • S:t Görans Hospital, Sweden
  • United Kingdom
      • London, United Kingdom
        • Imperial College London

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

5 years to 68 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Consent to participate voluntarily. Willing and able to comply with the study specific procedures. Signed Informed Consent prior to any study procedure.
  • Perennial allergic asthma, male and female, age 7 through 70 years, at time of randomization.
  • A miniAQLQ/PAQLQ score of ≤ 5.5.
  • Sensitive to pet allergen and/or house dust mites as demonstrated by changed to RAST 0.70 or positive skin prick test (wheal reaction similar to histamine control).
  • Daily maintenance dose of at least ICS ≥200µg/day of budesonide or ≥100µg/day of fluticasone since at least 6 months
  • Features of partly controlled asthma according to GINA

Exclusion Criteria:

  • Current smoker (Non-smoker is defined as abstinent since > 1 year). Children: Parents'indoor smoking.
  • Participation in another allergen avoidance program
  • Participation in drug trial the preceding 3 months
  • Multiple chemical sensitivity (e.g. paint, petrol, perfumes) as primary etiology
  • Allergen injection or sublingual treatment in the preceding 2 years
  • ICS ≥1200µg/day of budesonide or 1000µg/day of fluticasone
  • Significant cardiovascular disease
  • Participation in the present trial of a family member within the same household

Other protocol-defined exclusion criteria may apply

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: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Temeperature controlled Laminar Airflow
Active treatment with Temperature controlled Laminar Airflow (TLA)
Device: Temperature controlled Laminar Airflow (TLA)
Nocturnal environmental control with Temperature controlled Laminar Airflow (TLA).
Other Names:
  • Protexo
  • TLA
Placebo Comparator: Placebo TLA
Placebo TLA treatment
Device: Placebo TLA
Placebo TLA (without filtration and TLA function)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
miniAQLQ (Mini Asthma Quality of Life Questionnaire, Appendix 1) and the corresponding paediatric PAQLQ score.
Time Frame: Week -2, 0, 4, 12, 24, 36 and 52
Week -2, 0, 4, 12, 24, 36 and 52

Secondary Outcome Measures

Outcome Measure
Time Frame
FENO (Nitric Oxide in Exhaled Air)
Time Frame: Week -2, 0, 4, 12, 24, 36 and 52
Week -2, 0, 4, 12, 24, 36 and 52
Lung function assessed by forced expiratory volume (FEV1), PEF (Expiratory peak flow) and FEF50 (Predicted Forced Expiratory Flow Rate at 50 Percent of Vital Capacity)
Time Frame: Week -2, 0, 4, 12, 24, 36 and 52
Week -2, 0, 4, 12, 24, 36 and 52
Rhinitis symptoms assessed by questionnaire
Time Frame: Week 0 and 52
Week 0 and 52
RAST value and eosinophil count.
Time Frame: Week 0 and 52
Week 0 and 52
Asthma Control Test (ACT).
Time Frame: Week -2, 0, 12, 24, 36 and 52
Week -2, 0, 12, 24, 36 and 52
Resource consumption
Time Frame: Week 0, 4, 12, 24, 36 and 52
Week 0, 4, 12, 24, 36 and 52

Collaborators and Investigators

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

Sponsor

Airsonett AB

Collaborators

Commitum AB
Croel AB

Investigators

  • Principal Investigator: Olof Zetterström, MD, PhD., University Hospital, Linkoeping

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

April 1, 2008

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

September 27, 2009

First Submitted That Met QC Criteria

September 28, 2009

First Posted (Estimate)

September 29, 2009

Study Record Updates

Last Update Posted (Estimate)

November 9, 2010

Last Update Submitted That Met QC Criteria

November 8, 2010

Last Verified

November 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Air 3-03

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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