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The purpose of this study is to determine whether clean air administered to the breathing zone with Temperature regulated Laminar Airflow (TLA) during night 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 regulated Laminar Airflow (TLA) with a very low particle concentration directed to the breathing zone of subjects with allergic asthma during night sleep. The hypothesis is that the decreased allergen exposure during the night will have a positive effect on the peripheral bronchial airway. Measurements of lung clearing index, volume of trapped gas, alveolar nitric oxide, PAQLQ.
Method: This is a double blind, randomized 52 week parallel trial comparing active and placebo treatment with TLA. 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. 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.
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Protexo (Temperature controlled Laminar Airflow (TLA)), Placebo TLA
Astrid Lindgren Children s Hospital, Children's Department, Karolinska Hospital
SE 171 76
Active, not recruiting
Published on BioPortfolio: 2014-08-27T03:18:58-0400
The purpose of this study is to determine whether clean air administered to the breathing zone with Temperature regulated Laminar Airflow (TLA) during night is effective as add on treatmen...
The purpose of this study is to determine whether clean air administered to the breathing zone with Temperature controlled Laminar Airflow (TLA) during night is effective as add on treatme...
The purpose of this study is to determine whether clean air administered to the breathing zone with Temperature controlled Laminar Airflow (TLA) during night is effective in the treatment ...
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 perenn...
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Measurement of the temperature of a material, or of the body or an organ by various temperature sensing devices which measure changes in properties of the material that vary with temperature, such as ELASTICITY; MAGNETIC FIELDS; or LUMINESCENCE.
Implanted fluid propulsion systems with self-contained power source for providing long-term controlled-rate delivery of drugs such as chemotherapeutic agents or analgesics. Delivery rate may be externally controlled or osmotically or peristatically controlled with the aid of transcutaneous monitoring.
Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.
Asthma attacks caused, triggered, or exacerbated by OCCUPATIONAL EXPOSURE.
The maintenance of certain aspects of the environment within a defined space to facilitate the function of that space; aspects controlled include air temperature and motion, radiant heat level, moisture, and concentration of pollutants such as dust, microorganisms, and gases. (McGraw-Hill Dictionary of Scientific and Technical Terms, 4th ed)
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