Condition category
Respiratory
Date applied
15/08/2007
Date assigned
12/09/2007
Last edited
23/08/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Susanne Lau

ORCID ID

Contact details

Charite Campus Virchow University Children's Hospital
Department of Pediatric Pneumology
Augustenburger Platz 1
Berlin
13353
Germany
+49 (0)30 4506 66254
susanne.lau@gmx.net

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

91/99

Study information

Scientific title

Acronym

HEPA

Study hypothesis

The reduction of pet allergens in households of pet-sensitive asthmatic children with Hepa air filters reduces bronchial hyper-responsiveness after cold air challenge and possibly also pet allergen exposure after 6 and 12 months of treatment.

Ethics approval

Ethics approval received from the Ethics Committee of the Charite in May 1999.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Allergy and asthma

Intervention

Recruitment took place 3 - 4 months before the treatment started. After randomisation patients were allocated to two groups: active and sham filters placed in the living and bedroom of families with a cat or dog sensitive asthmatic child.

Filters were placed in the homes on month 0 and changed after 6 months. Treatment period was 12 months. There was no follow up after the treatment. Dust samples of house dust were collected before the treatment started (inclusion criterion pet allergen exposure greater than 500 ng/g) and on month 0, 6 and 12. They were analysed for Fel d 1 and Can f 1 (pet allergens). Furthermore, we extracted the filters on month 6 and 12 and measured major allergens of cat and dog, Can f 1 and Fel d 1.

Clinical evaluation (lung function testing, cold air challenge, symptom score, medication, questionnaire on quality of life [published by Elizabeth Juniper]) took place on month 0, month 6 and 12.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Forced Expiratory Volume in one second (FEV1) after cold air challenge on month 0, 6 and 12.

Secondary outcome measures

1. Symptom score
2. Quality of life questionnaire
3. Cat and dog allergen exposure in bulk dust and filters
4. Eosinophil Cationic Protein (ECP) levels in serum as a marker of inflammation

Secondary outcomes were measured on month 0, 6 and 12.

Overall trial start date

01/10/1999

Overall trial end date

31/10/2000

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 6 to 18 years
2. Significant cat or dog allergen exposure greater than 500 ng/g in house dust
3. A doctor's diagnosis of asthma, sensitisation (serum Immunoglobulin E [IgE] to cat and/or dog)

Participant type

Patient

Age group

Child

Gender

Not Specified

Target number of participants

36 enrolled, 3 participants had to be excluded due to bad compliance, 3 dropped out later. 30 finished the study.

Participant exclusion criteria

1. Systemic corticosteroids
2. Mite allergy above 0.7 KU/L
3. Missing consent of parents

Recruitment start date

01/10/1999

Recruitment end date

31/10/2000

Locations

Countries of recruitment

Germany

Trial participating centre

Charite Campus Virchow University Children's Hospital
Berlin
13353
Germany

Sponsor information

Organisation

Incen AG (Switzerland)

Sponsor details

Blumenfeldtrasse 15
Goldach
CH-9403
Switzerland
+41 (0)71 8440844
info@incen.com

Sponsor type

Industry

Website

http://www.incen.com

Funders

Funder type

Industry

Funder name

Incen AG (Switzerland) - provided filter systems

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Charite - University Medicine Berlin (Germany) - provided funding for nurses, doctors, students

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Poster on European Academy of Allergology and Clinical Immunology (EAACI) congress in Naples, 2002

Publication citations

Additional files

Editorial Notes