Contact information
Type
Scientific
Primary contact
Prof Ashley Woodcock
ORCID ID
Contact details
North West Lung Centre
South Manchester University Hospitals NHS Trust
Wythenshawe Hospital
Southmoor Road
Manchester
M23 9LT
United Kingdom
+44 (0)161 291 5873
ashley.woodcock@manchester.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0226111705
Study information
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
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Double-blind placebo-controlled randomised cross-over study
Primary study design
Interventional
Secondary study design
Randomised cross over trial
Trial setting
Not specified
Trial type
Other
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
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
Phase
Drug names
Primary outcome measures
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).
Secondary outcome measures
Not provided at time of registration
Overall trial start date
27/05/2002
Overall trial end date
31/12/2003
Reason abandoned
Eligibility
Participant 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
Participant type
Healthy volunteer
Age group
Adult
Gender
Both
Target number of participants
10
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
27/05/2002
Recruitment end date
31/12/2003
Locations
Countries of recruitment
United Kingdom
Trial participating centre
North West Lung Centre
Manchester
M23 9LT
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Charity
Funder name
North West Lung Centre Charity (UK)
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