NCT00987064

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for phase_2 asthma

Timeline
Completed

Started Oct 2005

Shorter than P25 for phase_2 asthma

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

September 28, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 30, 2009

Completed
Last Updated

January 14, 2015

Status Verified

September 1, 2009

Enrollment Period

7 months

First QC Date

September 28, 2009

Last Update Submit

January 13, 2015

Conditions

AsthmaPerennial Allergy

Keywords

ProtexoAsthmaTemperature controlled Laminar AirflowPerennial allergyQuality of lifeMiniAQLQFeNOFEV1PEF

Outcome Measures

Primary Outcomes (1)

  • Quality of life assessed by mini Asthma Quality of Life Questionnaire (miniAQLQ)

    Every 2 weeks of the study period

Secondary Outcomes (2)

  • Airway inflammation measurement assessed by Exhaled nitric oxide (FeNO)

    Every 5 week of the study period

  • Lung function (FeV1, PEF)

    Every 5 week of the study period

Study Arms (2)

Temperature controlled Laminar Airflow

ACTIVE COMPARATOR

Active treatment with Temperature controlled Laminar Airflow (TLA)

Device: Temperature controlled Laminar Airflow (Protexo)

Placebo TLA

PLACEBO COMPARATOR

Placebo treatment with TLA (no filtration function)

Device: Placebo TLA

Interventions

Temperature controlled Laminar Airflow (Protexo)DEVICE

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.

Also known as: Protexo
Temperature controlled Laminar Airflow
Placebo TLADEVICE

TLA treatment with disabled filtration function

Placebo TLA

Eligibility Criteria

Age12 Years - 28 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Diagnosed for asthma for more than 1 year.
  • More than 12% reactivity in FEV1 on bronchodilating medication or less than 90% of the FEV1 reference value according to Hedenström.
  • Perennial allergy
  • At least 3-mm wheal reaction in a skin prick test to at least one of following: House dust, Mold spores, dust mites, animal hair and dander.
  • Little or no reactivity to other inhalant allergens.
  • No known allergy to another inhalant allergen or chemical to which there is exposure in winter time.
  • No allergen injection treatment in the preceding 2 years.
  • A history of a requirement for daily medication for asthma including;
  • µg steroid medication (Pulmicort or equal) for children and 800µg for adults.
  • Beta agonist treatment on less than 4 days per week.
  • Willingness to follow the clinical trial protocol, including medications, baseline and follow-up visits and procedures.

You may not qualify if:

  • Smoking in the family
  • Participation in a drug trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Hospital, Linkoeping

Linköping, SE-581 91, Sweden

Location

Karolinska University Hospital

Stockholm, SE-171 76, Sweden

Location

Related Publications (1)

  • Pedroletti C, Millinger E, Dahlen B, Soderman P, Zetterstrom O. Clinical effects of purified air administered to the breathing zone in allergic asthma: A double-blind randomized cross-over trial. Respir Med. 2009 Sep;103(9):1313-9. doi: 10.1016/j.rmed.2009.03.020. Epub 2009 May 13.

    PMID: 19443189BACKGROUND

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Christophe Pedroletti, MD, PhD.

    Karolinska University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 28, 2009

First Posted

September 30, 2009

Study Start

October 1, 2005

Primary Completion

May 1, 2006

Study Completion

June 1, 2006

Last Updated

January 14, 2015

Record last verified: 2009-09

Locations

SE(2)