Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Commitum AB | INDUSTRY |
| Croel AB | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Temeperature controlled Laminar Airflow | Active Comparator | Active treatment with Temperature controlled Laminar Airflow (TLA) |
|
| Placebo TLA | Placebo Comparator | Placebo TLA treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Temperature controlled Laminar Airflow (TLA) | Device | Nocturnal environmental control with Temperature controlled Laminar Airflow (TLA). |
|
| Measure | Description | Time Frame |
|---|---|---|
| miniAQLQ (Mini Asthma Quality of Life Questionnaire, Appendix 1) and the corresponding paediatric PAQLQ score. | Week -2, 0, 4, 12, 24, 36 and 52 |
| Measure | Description | Time Frame |
|---|---|---|
| FENO (Nitric Oxide in Exhaled Air) | 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) | Week -2, 0, 4, 12, 24, 36 and 52 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined exclusion criteria may apply
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Olof Zetterström, MD, PhD. | University Hospital, Linkoeping | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University Hospital | Aarhus | Denmark | ||||
| Bispebjerg Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22131290 | Derived | Boyle RJ, Pedroletti C, Wickman M, Bjermer L, Valovirta E, Dahl R, Von Berg A, Zetterstrom O, Warner JO; 4A Study Group. Nocturnal temperature controlled laminar airflow for treating atopic asthma: a randomised controlled trial. Thorax. 2012 Mar;67(3):215-21. doi: 10.1136/thoraxjnl-2011-200665. Epub 2011 Nov 30. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Placebo TLA | Device | Placebo TLA (without filtration and TLA function) |
|
| Rhinitis symptoms assessed by questionnaire | Week 0 and 52 |
| RAST value and eosinophil count. | Week 0 and 52 |
| Asthma Control Test (ACT). | Week -2, 0, 12, 24, 36 and 52 |
| Resource consumption | Week 0, 4, 12, 24, 36 and 52 |
| Copenhagen |
| Denmark |
| Turku Allergy Centre | Turku | Finland |
| Ruhr University of Bochum | Bochum | Germany |
| University of München | München | Germany |
| University of Rostock | Rostock | Germany |
| Marien Hospital Wesel | Wesel | Germany |
| Ullevaal University Hospital | Oslo | Norway |
| St. Olavs Hospital | Trondheim | Norway |
| Ängelholm Hospital | Ängelholm | Sweden |
| Sahlgrenska University Hospital, Sweden | Gothenburg | Sweden |
| Jonkoping County Hospital | Jönköping | Sweden |
| County Council of Värmland | Karlstad | Sweden |
| University Hospital, Linkoeping | Linköping | Sweden |
| Lund University Hospital | Lund | Sweden |
| Karolinska University Hospital | Stockholm | SE-171 76 | Sweden |
| S:t Görans Hospital, Sweden | Stockholm | Sweden |
| Stockholm South General Hospital | Stockholm | Sweden |
| Imperial College London | London | United Kingdom |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided