The effect of Der p 1 inhalation on bronchial responsiveness to inhaled cat allergen in asthmatics sensitised to cat but not to house dust mite
| ISRCTN | ISRCTN70706542 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN70706542 |
| Protocol serial number | N0226111705 |
| Sponsor | Department of Health (UK) |
| Funder | North West Lung Centre Charity (UK) |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 11/10/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Ashley Woodcock
Scientific
Scientific
North West Lung Centre
South Manchester University Hospitals NHS Trust
Wythenshawe Hospital
Southmoor Road
Manchester
M23 9LT
United Kingdom
| Phone | +44 (0)161 291 5873 |
|---|---|
| ashley.woodcock@manchester.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Double-blind placebo-controlled randomised cross-over study |
| Secondary study design | Randomised cross over trial |
| Study type | Participant information sheet |
| Scientific title | The effect of Der p 1 inhalation on bronchial responsiveness to inhaled cat allergen in asthmatics sensitised to cat but not to house dust mite |
| Study objectives | To detect whether bronchial responsiveness to cat allergen, in a subject sensitised to cat, but not dust mite, may be enhanced by the presence of Dermatophagoides pteronyssinus 1 (Der p 1), a cysteine peptidase allergen. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Asthma |
| Intervention | Double-blind, placebo-controlled, randomised, cross-over study. Patients are randomised to: 1. Dermatophagoides pteronyssinus 1 (Der p 1), a cysteine peptidase allergen 2. Placebo |
| Intervention type | Other |
| Primary outcome measure(s) |
The measure of cat allergen PD20, that is the cumulative dose of cat allergen required to cause a 20% fall in forced expiratory volume in one second (FEV1). |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/12/2003 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 10 |
| Key inclusion criteria | 10 subjects, volunteers selected from the MEU database who have had previous skin prick testing and identified as being sensitised to cat and not house dust mite |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 27/05/2002 |
| Date of final enrolment | 31/12/2003 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
North West Lung Centre
Manchester
M23 9LT
United Kingdom
M23 9LT
United Kingdom
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? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
11/10/2016: No publications found, verifying study status with principal investigator.
