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Clinical Effects of Temperature Controlled Laminar Airflow (TLA)

NCT00987064 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2015-01-14

No results posted yet for this study

Summary

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 of perennial allergic asthma.

Conditions

Interventions

DEVICE

Temperature controlled Laminar Airflow (Protexo)

The intervention is designed to reduce the allergen load in the patients breathing zone by vertically displacing the allergens, originating from the bed and the ambient room environment, with a temperature controlled laminar airflow (TLA) during night sleep. The airflow is filtered through a high efficiency particulate air filter(HEPA), slightly cooled and ''showered'' over the subject. Due to the higher density, the cooled air descends slowly, and displaces the allergens from the breathing zone.

DEVICE

Placebo TLA

TLA treatment with disabled filtration function

Sponsors & Collaborators

  • Karolinska University Hospital

    collaborator OTHER

  • University Hospital, Linkoeping

    collaborator OTHER

  • Quintiles, Inc.

    collaborator INDUSTRY

  • Airsonett AB

    lead INDUSTRY

Principal Investigators

  • Christophe Pedroletti, MD, PhD. · Karolinska University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
12 Years
Max Age
28 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-10-31
Primary Completion
2006-05-31
Completion
2006-06-30

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00987064 on ClinicalTrials.gov