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
Secondary identifying numbers N0226111705
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

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
Email ashley.woodcock@manchester.ac.uk

Study information

Study designDouble-blind placebo-controlled randomised cross-over study
Primary study designInterventional
Secondary study designRandomised cross over trial
Study setting(s)Not specified
Study typeOther
Participant information sheet Not available in web format, please use contact details to request a participant information sheet
Scientific titleThe 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 objectivesTo 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) studiedAsthma
InterventionDouble-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 typeOther
Primary outcome measureThe 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 measuresNot provided at time of registration
Overall study start date27/05/2002
Completion date31/12/2003

Eligibility

Participant type(s)Healthy volunteer
Age groupAdult
SexBoth
Target number of participants10
Key inclusion criteria10 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 criteriaNot provided at time of registration
Date of first enrolment27/05/2002
Date of final enrolment31/12/2003

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

North West Lung Centre
Manchester
M23 9LT
United Kingdom

Sponsor information

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website http://www.doh.gov.uk

Funders

Funder type

Charity

North West Lung Centre Charity (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

11/10/2016: No publications found, verifying study status with principal investigator.