Condition category
Respiratory
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
27/09/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr. Glenis K Scadding

ORCID ID

Contact details

Department of Rhinology
RNTNE
Royal Free Hampstead NHS Trust
330 Grays Inn Road
Kings Cross
London
WC1X 8DA
United Kingdom
+44 020 7915 1542
g.scadding@ucl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0256107987

Study information

Scientific title

Acronym

Study hypothesis

To see whether sublingual immunotherapy and probiotics given in combination will provide a safe effective means of modifying allergic disease expression and whether this will provide a safe and effective mode of treatment for common use.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Respiratory: Housedust allergy

Intervention

Randomised controlled trial comparing sublingual immunotherapy and probiotics with standard treatment.

July 2008: the trial was stopped in 2003

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Service outcome development.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/09/2002

Overall trial end date

30/09/2004

Reason abandoned

Product to be used became unusable.

Eligibility

Participant inclusion criteria

Not provided at time of registration

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

80 patients

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/09/2002

Recruitment end date

30/09/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Rhinology, RNTNE
London
WC1X 8DA
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

Government

Funder name

The Royal Free Hampstead NHS Trust (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