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

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ClinicalTrials.gov Identifier: NCT00986323
Recruitment Status : Completed
First Posted : September 29, 2009
Last Update Posted : November 9, 2010
Sponsor:
Collaborators:
Commitum AB
Croel AB
Information provided by:
Airsonett AB

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Asthma Device: Temperature controlled Laminar Airflow (TLA) Device: Placebo TLA Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 312 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Airsonett Airshower in Allergic Asthma a Double-blind Randomized Multi-centre Trial
Study Start Date : April 2008
Actual Primary Completion Date : February 2010
Actual Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arms and Interventions
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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)


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. FENO (Nitric Oxide in Exhaled Air) [ Time Frame: Week -2, 0, 4, 12, 24, 36 and 52 ]
  2. 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 ]
  3. Rhinitis symptoms assessed by questionnaire [ Time Frame: Week 0 and 52 ]
  4. RAST value and eosinophil count. [ Time Frame: Week 0 and 52 ]
  5. Asthma Control Test (ACT). [ Time Frame: Week -2, 0, 12, 24, 36 and 52 ]
  6. Resource consumption [ Time Frame: Week 0, 4, 12, 24, 36 and 52 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00986323


Locations
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Sponsors and Collaborators
Airsonett AB
Commitum AB
Croel AB
Investigators
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Principal Investigator: Olof Zetterström, MD, PhD. University Hospital, Linkoeping
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Prof. Dr. Chris Anderson, Head of activity, University Hospital, Linkoeping, Sweden
ClinicalTrials.gov Identifier: NCT00986323    
Obsolete Identifiers: NCT00986388, NCT00986622, NCT00986726, NCT00986934
Other Study ID Numbers: Air 3-03
First Posted: September 29, 2009    Key Record Dates
Last Update Posted: November 9, 2010
Last Verified: November 2010
Keywords provided by Airsonett AB:
Asthma
Temperature controlled Laminar Airflow
TLA
 Perennial allergy
Quality of life
Environmental control
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
 Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases