Advertisement

Topics

Effect of Temperature Controlled Laminar Airflow (TLA) on the Peripheral Bronchial Airway in Asthma

2014-08-27 03:18:58 | BioPortfolio

Summary

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.

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 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.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Asthma

Intervention

Protexo (Temperature controlled Laminar Airflow (TLA)), Placebo TLA

Location

Astrid Lindgren Children s Hospital, Children's Department, Karolinska Hospital
Stockholm
Sweden
SE 171 76

Status

Active, not recruiting

Source

Airsonett AB

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:18:58-0400

Clinical Trials [2150 Associated Clinical Trials listed on BioPortfolio]

Effect of Temperature Controlled Laminar Airflow (TLA) on Nasal Airway Inflammation and Sleep Quality in Asthma

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...

Effect of Temperature Controlled Laminar Airflow (TLA) on Rhinitis

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...

Clinical Effects of Temperature Controlled Laminar Airflow (TLA)

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 ...

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

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...

Laminar Airflow in Severe Asthma for Exacerbation Reduction - 48 Month Follow-up.

Temperature-controlled Laminar Airflow (TLA) treatment delivered by the Airsonett treatment device is a new treatment for patients with allergic asthma. The LASER Trial (temperature-contr...

PubMed Articles [10740 Associated PubMed Articles listed on BioPortfolio]

What is New in the Management of Childhood Asthma?

Asthma still causes considerable morbidity and mortality globally and minimal improvement has been seen in key outcomes over the last decade despite increasing treatment costs. This review summarizes ...

Alfred William (Bill) Frankland.

First double- blind, placebo - controlled trials in allergy: grass pollen immunotherapy proved effective. but bacterial vaccines lacked efficacy in asthma. First Secretary of BSACI. Instituted the UK ...

Clinical characterization of children with resistant airflow obstruction, a multicenter study.

To characterize a cohort of children with airflow limitation resistant to bronchodilator (BD) therapy.

Anti-IL5 in Mild Asthma Alters Rhinovirus-Induced Macrophage, B Cell and Neutrophil Responses (MATERIAL): A Placebo-Controlled, Double-Blind Study.

Eosinophils drive pathophysiology in stable and exacerbating eosinophilic asthma and therefore treatment is focused on the reduction of eosinophil numbers. Mepolizumab, a humanized monoclonal antibody...

Clinical Experience of Overnight use of a Temperature-controlled Airflow Device in a Teenager with Severe Atopic Dermatitis.

Medical and Biotech [MESH] Definitions

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)

More From BioPortfolio on "Effect of Temperature Controlled Laminar Airflow (TLA) on the Peripheral Bronchial Airway in Asthma"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Asthma
Asthma is caused by inflammation of small tubes, called bronchi, which carry air in and out of the lungs. If you have asthma, the bronchi will be inflamed and more sensitive than normal.  When you come into contact with something that irritates your...

Allergies
The term allergy is used to describe a response, within the body, to a substance, which is not necessarily harmful in itself, but results in an immune response and a reaction that causes symptoms and disease in a predisposed person, which in turn can cau...


Searches Linking to this Trial