Effect of HEPA filter air cleaners (IQAir®/Incleen®) in homes of asthmatic children and adolescents sensitised to cat and dog allergens
| ISRCTN | ISRCTN82127731 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN82127731 |
| Protocol serial number | 91/99 |
| Sponsor | Incen AG (Switzerland) |
| Funders | Incen AG (Switzerland) - provided filter systems, Charite - University Medicine Berlin (Germany) - provided funding for nurses, doctors, students |
- Submission date
- 15/08/2007
- Registration date
- 12/09/2007
- Last edited
- 12/04/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Susanne Lau
Scientific
Scientific
Charite Campus Virchow University Children's Hospital
Department of Pediatric Pneumology
Augustenburger Platz 1
Berlin
13353
Germany
| Phone | +49 (0)30 4506 66254 |
|---|---|
| susanne.lau@gmx.net |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Effect of HEPA filter air cleaners (IQAir®/Incleen®) in homes of asthmatic children and adolescents sensitised to cat and dog allergens |
| Study acronym | HEPA |
| Study objectives | 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(s) | Ethics approval received from the Ethics Committee of the Charite in May 1999. |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
Forced Expiratory Volume in one second (FEV1) after cold air challenge on month 0, 6 and 12. |
| Key secondary outcome measure(s) |
1. Symptom score |
| Completion date | 31/10/2000 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Years |
| Upper age limit | 18 Years |
| Sex | Not Specified |
| Target sample size at registration | 36 |
| Total final enrolment | 36 |
| Key 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) |
| Key exclusion criteria | 1. Systemic corticosteroids 2. Mite allergy above 0.7 KU/L 3. Missing consent of parents |
| Date of first enrolment | 01/10/1999 |
| Date of final enrolment | 31/10/2000 |
Locations
Countries of recruitment
- Germany
Study participating centre
Charite Campus Virchow University Children's Hospital
Berlin
13353
Germany
13353
Germany
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/01/2009 | 12/04/2021 | Yes | No |
Editorial Notes
12/04/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
