Air Cleaners for Children and Adolescents With Asthma and Dog Allergy - Full Text View

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:

MedlinePlus related topics: Allergy Asthma Methamphetamine

U.S. FDA Resources

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

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

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:

Green R, Simpson A, Custovic A, Faragher B, Chapman M, Woodcock A. The effect of air filtration on airborne dog allergen. Allergy. 1999 May;54(5):484-8.

van der Heide S, van Aalderen WM, Kauffman HF, Dubois AE, de Monchy JG. Clinical effects of air cleaners in homes of asthmatic children sensitized to pet allergens. J Allergy Clin Immunol. 1999 Aug;104(2 Pt 1):447-51.

Wood RA. Air filtration devices in the control of indoor allergens. Curr Allergy Asthma Rep. 2002 Sep;2(5):397-400. Review.

McDonald E, Cook D, Newman T, Griffith L, Cox G, Guyatt G. Effect of air filtration systems on asthma: a systematic review of randomized trials. Chest. 2002 Nov;122(5):1535-42. Review.

Gore RB, Bishop S, Durrell B, Curbishley L, Woodcock A, Custovic A. Air filtration units in homes with cats: can they reduce personal exposure to cat allergen? Clin Exp Allergy. 2003 Jun;33(6):765-9.

Simpson A, Simpson B, Custovic A, Craven M, Woodcock A. Stringent environmental control in pregnancy and early life: the long-term effects on mite, cat and dog allergen. Clin Exp Allergy. 2003 Sep;33(9):1183-9.

Woodcock A, Lowe LA, Murray CS, Simpson BM, Pipis SD, Kissen P, Simpson A, Custovic A; NAC Manchester Asthma and Allergy Study Group. Early life environmental control: effect on symptoms, sensitization, and lung function at age 3 years. Am J Respir Crit Care Med. 2004 Aug 15;170(4):433-9. Epub 2004 May 13.

Lowe LA, Woodcock A, Murray CS, Morris J, Simpson A, Custovic A. Lung function at age 3 years: effect of pet ownership and exposure to indoor allergens. Arch Pediatr Adolesc Med. 2004 Oct;158(10):996-1001.

Arbes SJ Jr, Cohn RD, Yin M, Muilenberg ML, Friedman W, Zeldin DC. Dog allergen (Can f 1) and cat allergen (Fel d 1) in US homes: results from the National Survey of Lead and Allergens in Housing. J Allergy Clin Immunol. 2004 Jul;114(1):111-7.

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:

Hypersensitivity
Asthma
Immune System Diseases
Bronchial Diseases
Respiratory Tract Diseases

Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate

ClinicalTrials.gov processed this record on May 19, 2013