Condition category
Respiratory
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
11/10/2016
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

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

http://www.doh.gov.uk

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

Publication citations

Additional files

Editorial Notes

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