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

This study has been completed.
Sponsor:
Collaborators:
Commitum AB
Croel AB
Information provided by:
Airsonett AB
ClinicalTrials.gov Identifier:
NCT00986323
First received: September 27, 2009
Last updated: November 8, 2010
Last verified: November 2010
  Purpose

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.


Condition Intervention Phase
Asthma
Device: Temperature controlled Laminar Airflow (TLA)
Device: Placebo TLA
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Airsonett Airshower in Allergic Asthma a Double-blind Randomized Multi-centre Trial

Resource links provided by NLM:


Further study details as provided by Airsonett AB:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • FENO (Nitric Oxide in Exhaled Air) [ Time Frame: Week -2, 0, 4, 12, 24, 36 and 52 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Rhinitis symptoms assessed by questionnaire [ Time Frame: Week 0 and 52 ] [ Designated as safety issue: No ]
  • RAST value and eosinophil count. [ Time Frame: Week 0 and 52 ] [ Designated as safety issue: No ]
  • Asthma Control Test (ACT). [ Time Frame: Week -2, 0, 12, 24, 36 and 52 ] [ Designated as safety issue: No ]
  • Resource consumption [ Time Frame: Week 0, 4, 12, 24, 36 and 52 ] [ Designated as safety issue: No ]

Enrollment: 312
Study Start Date: April 2008
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

  Eligibility

Ages Eligible for Study:   7 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  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: NCT00986323

Locations
Denmark
Aarhus University Hospital
Aarhus, Denmark
Bispebjerg Hospital
Copenhagen, Denmark
Finland
Turku Allergy Centre
Turku, Finland
Germany
Ruhr University of Bochum
Bochum, Germany
University of München
München, Germany
University of Rostock
Rostock, Germany
Marien Hospital Wesel
Wesel, Germany
Norway
Ullevaal University Hospital
Oslo, Norway
St. Olavs Hospital
Trondheim, Norway
Sweden
Ängelholm Hospital
Angelholm, Sweden
Sahlgrenska University Hospital, Sweden
Gothenburg, Sweden
Jonkoping County Hospital
Jonkoping, Sweden
County Council of Värmland
Karlstad, Sweden
University Hospital, Linkoeping
Linkoeping, Sweden
Lund University Hospital
Lund, Sweden
Karolinska University Hospital
Stockholm, Sweden, SE-171 76
S:t Görans Hospital, Sweden
Stockholm, Sweden
Stockholm South General Hospital
Stockholm, Sweden
United Kingdom
Imperial College London
London, United Kingdom
Sponsors and Collaborators
Airsonett AB
Commitum AB
Croel AB
Investigators
Principal Investigator: Olof Zetterström, MD, PhD. University Hospital, Linkoeping
  More Information

No publications provided by Airsonett AB

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Dr. Chris Anderson, Head of activity, University Hospital, Linkoeping, Sweden
ClinicalTrials.gov Identifier: NCT00986323     History of Changes
Other Study ID Numbers: Air 3-03
Study First Received: September 27, 2009
Last Updated: November 8, 2010
Health Authority: Sweden: Medical Products Agency
Sweden: Regional Ethical Review Board
Norway: Norwegian Medicines Agency
Norway:National Committee for Medical and Health Research Ethics
Denmark: Danish Medicines Agency
Denmark: Ethics Committee
Finland: Ethics Committee
Finland: Finnish Medicines Agency
Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee

Keywords provided by Airsonett AB:
Asthma
Temperature controlled Laminar Airflow
TLA
Perennial allergy
Quality of life
Environmental control

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 August 25, 2014