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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

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