Air Cleaners for Children and Adolescents With Asthma and Dog Allergy

NCT00220753 | Completed DMC

• 2 other identifiers: AIR CLEANER TRIAL 2 SIHFPARTIAL SPONSOR INCEN AG
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Asthma; Allergy

Keywords

Dog allergy; Pet allergy; Air cleaners; HEPA filters; Air filtration; Can f1; Asthma; Children; Adolescents; Indoor environment; Indoor allergy; Perennial allergy

Outcome Measures

Primary Outcomes (1)

• Bronchial hyperactivity by cold air hyperventilation

  September 2005 - February 2006

Secondary Outcomes (3)

• Serum ECP

  September 2005- February 2006

• Asthma symptom score

  September 2005 - February 2006

• Allergic rhinitis symptom score

  September 2005 - February 2006

Study Arms (2)

Active air cleaner

ACTIVE COMPARATOR

Two Icleen IQAir air cleaners with active filters supplied

Device: IQAir Allergen 100 Air cleaners

Placebo air cleaner

PLACEBO COMPARATOR

Two Icleen IQAir air cleaners with placebo filters supplied

Device: IQAir Allergen 100 Air cleaners

Interventions

IQAir Allergen 100 Air cleaners DEVICE

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.

Also known as: Health Pro

Active air cleaner; Placebo air cleaner

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sykehuset Innlandet HF: lead
• Incen AG: collaborator

Study Sites (1)

Barnepoliklinikken, Sykehuset Innlandet HF

Hamar, N-2326, Norway

Location

Related Publications (9)

• 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. doi: 10.1034/j.1398-9995.1999.00029.x.

  PMID: 10380780 BACKGROUND

• 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. doi: 10.1016/s0091-6749(99)70391-x.

  PMID: 10452769 BACKGROUND

• Wood RA. Air filtration devices in the control of indoor allergens. Curr Allergy Asthma Rep. 2002 Sep;2(5):397-400. doi: 10.1007/s11882-002-0073-3.

  PMID: 12165206 BACKGROUND

• 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. doi: 10.1378/chest.122.5.1535.

  PMID: 12426250 BACKGROUND

• 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. doi: 10.1046/j.1365-2222.2003.01678.x.

  PMID: 12801310 BACKGROUND

• 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. doi: 10.1046/j.1365-2745.2003.01679.x.

  PMID: 12956752 BACKGROUND

• 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. doi: 10.1164/rccm.200401-083OC. Epub 2004 May 13.

  PMID: 15142868 BACKGROUND

• 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. doi: 10.1001/archpedi.158.10.996.

  PMID: 15466689 BACKGROUND

• 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. doi: 10.1016/j.jaci.2004.04.036.

  PMID: 15241352 BACKGROUND

MeSH Terms

Conditions

Asthma; Hypersensitivity

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Immune System Diseases

Study Officials

• Leif B. Rolfsjord, M.D.

  Sykehuset Innlandet HF

  PRINCIPAL INVESTIGATOR

• 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 19, 2005
• First Posted: September 22, 2005
• Study Start: September 1, 2005
• Primary Completion: February 1, 2006
• Study Completion: April 1, 2006
• Last Updated: July 23, 2009

Record last verified: 2009-07

Locations

NO (1)