Air Cleaners for Children and Adolescents With Asthma and Dog Allergy

This study has been completed.
Sponsor:
Collaborator:
Incen AG
Information provided by:
Sykehuset Innlandet HF
ClinicalTrials.gov Identifier:
NCT00220753
First received: September 19, 2005
Last updated: July 21, 2009
Last verified: July 2009
  Purpose

The purpose is to find out if Icleen IQAir, HEPA-filter air cleaners with high capacity and pre-set speed functions, have a beneficial effect on patients with asthma and allergy to dogs.

Air cleaners will be installed in the bedrooms and living rooms in the homes of children and adolescents aged 8-17 years at the study entry, with allergy to dogs, but not to house dust mites.

The investigators will look upon the significance of this study, and of a previous study with a similar design and the same main parameters to find out if this trial supports the results of the first trial by the same project leader, or makes it likely that the seemingly beneficial effects of the first study occurred by chance.

Main parameters:

  • hyperventilation cold air challenge test

Supportive parameters:

  • serum ECP
  • symptom scores

The trial will be a parallel, double blind placebo controlled one.


Condition Intervention
Asthma
Allergy
Device: IQAir Allergen 100 Air cleaners

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Air Cleaners for Children and Adolescents With Asthma and Dog Allergy

Resource links provided by NLM:


Further study details as provided by Sykehuset Innlandet HF:

Primary Outcome Measures:
  • Bronchial hyperactivity by cold air hyperventilation [ Time Frame: September 2005 - February 2006 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Serum ECP [ Time Frame: September 2005- February 2006 ] [ Designated as safety issue: No ]
  • Asthma symptom score [ Time Frame: September 2005 - February 2006 ] [ Designated as safety issue: No ]
  • Allergic rhinitis symptom score [ Time Frame: September 2005 - February 2006 ] [ Designated as safety issue: No ]

Enrollment: 22
Study Start Date: September 2005
Study Completion Date: April 2006
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Active air cleaner
Two Icleen IQAir air cleaners with active filters supplied
Device: IQAir Allergen 100 Air cleaners
Two air cleaners are installed in the patient's room, one in his bedroom, and one in the living room. The cleaners can be run at 5 different speeds: Speed 1 filtrates 60m3 of air per hour, speed 2 filtrates 90 m3 per hour, speed 3 filtrates 130 m3 per hour, speed 4 filtrates 240 m3 per hour, and speed 5 filtrates 380 m3 per hour. A timer-on period can be pre-set for every day of the week, but the cleaner can be run even in the timer-off period, at a speed pre-set and different from the timer-on period. Different timer-on off periods cannot be selected for different days, but the different days of the week can be pre-set to apply timer-on periods or not.
Other Name: Health Pro
Placebo Comparator: Placebo air cleaner
Two Icleen IQAir air cleaners with placebo filters supplied
Device: IQAir Allergen 100 Air cleaners
Two air cleaners are installed in the patient's room, one in his bedroom, and one in the living room. The cleaners can be run at 5 different speeds: Speed 1 filtrates 60m3 of air per hour, speed 2 filtrates 90 m3 per hour, speed 3 filtrates 130 m3 per hour, speed 4 filtrates 240 m3 per hour, and speed 5 filtrates 380 m3 per hour. A timer-on period can be pre-set for every day of the week, but the cleaner can be run even in the timer-off period, at a speed pre-set and different from the timer-on period. Different timer-on off periods cannot be selected for different days, but the different days of the week can be pre-set to apply timer-on periods or not.
Other Name: Health Pro

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   8 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children and adolescents between 8 and 17 years of age at the start of the trial (born after 01 March '88, but before 01 September '97).
  • Bronchial asthma, diagnosed by a physician, and confirmed by a physician at a paediatric department of a Norwegian Hospital.
  • Allergy against dogs, confirmed by skin prick test. Average infiltrate at least 4 millimetres against dog, diagnosed by a new skin prick test at entry. For details about skin prick test, see attachment no. 6.
  • Having had nose or breathing symptoms by contact with dogs, when no drugs against asthma or allergy have been taken.
  • Able to co-operate at cold air hyperventilation test and spirometry (see attachment no. 2).
  • Given written consent (by parents of children below 12; by parents and child when above 12, but below 16; by patient when above 16).

Exclusion Criteria:

  • Positive house dust mite skin prick test, with a more than 3 mm infiltrate.
  • Having taken oral beta-2-agonists or theophylline preparations for the last 2 weeks before trial start, or oral steroids for the last 3 months before start of the trial.
  • Active smoking.
  • Dogs or cats in the home.
  • Staying away from the home continuously for more than 14 days in the trial period or during the last month before trial start.
  • Being an in-patient in a special department or institution for asthma and allergy in the trial period or the last 3 months before the trial.
  • Having another chronic disease that can influence the results of ECP or cold air hyperreactivity tests.
  • Other types of mechanical ventilation or air filtration systems in the homes, except for those for kitchen stoves.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00220753

Locations
Norway
Barnepoliklinikken, Sykehuset Innlandet HF
Hamar, Norway, N-2326
Sponsors and Collaborators
Sykehuset Innlandet HF
Incen AG
Investigators
Principal Investigator: Leif B. Rolfsjord, M.D. Sykehuset Innlandet HF
Study Chair: Leiv Sandvik, PhD Oslo Universitetssykehus Ulleval
Study Chair: Ragnhild Halvorsen, M.D., Ph.D. Oslo Universitetssykehus Rikshospitalet
Study Chair: Sten Dreborg, M.D., Ph.D. Alingsåsv. 11, S-443 35 Lerum, Sweden
  More Information

Publications:

Responsible Party: Leif Bjarte Rolfsjord/ seksjonsoverlege, Sykehuset Innlandet HF
ClinicalTrials.gov Identifier: NCT00220753     History of Changes
Other Study ID Numbers: AIR CLEANER TRIAL 2 SIHF, PARTIAL SPONSOR INCEN AG
Study First Received: September 19, 2005
Last Updated: July 21, 2009
Health Authority: Norway: Norwegian Social Science Data Services
Norway: Directorate of Health

Keywords provided by Sykehuset Innlandet HF:
Dog allergy
Pet allergy
Air cleaners
HEPA filters
Air filtration
Can f1
Asthma
Children
Adolescents
Indoor environment
Indoor allergy
Perennial allergy

Additional relevant MeSH terms:
Asthma
Hypersensitivity
Bronchial Diseases
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 20, 2014