Efficacy Study of Temperature Controlled Laminar Airflow (TLA)-Treatment in Perennial Allergic Asthma (4A)
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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 |
- 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 ]
- 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:
|
|
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 |
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| 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 | |
| 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 May 19, 2013