Condition category
Respiratory
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
18/11/2008
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

Dr K.A.B.M. Peeters

ORCID ID

Contact details

University Medical Centre Utrecht
Department of Dermatology/Allergology
P.O. Box 85500
Utrecht
3508 GA
Netherlands
+31 (0)30 250 7388
K.A.B.M.Peeters@umcutrecht.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR172

Study information

Scientific title

The effect of birch pollen immunotherapy on hazelnut allergy evaluated by DBPCFC with hazelnut

Acronym

Study hypothesis

The severity of hazelnut allergy will decrease as an additional effect by birch pollen immunotherapy.

Ethics approval

Received from the local medical ethics committee

Study design

Randomised, double-blind, placebo controlled, parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Pollen/hazelnut allergy

Intervention

Immunotherapy with birch pollen extract.

Intervention type

Drug

Phase

Not Specified

Drug names

Birch pollen extract

Primary outcome measures

DBPCFC with hazelnut before immunotherapy with birch pollen and after 1 year.

Secondary outcome measures

1. Skin prick tests
2. Serological analyses

Overall trial start date

01/04/2004

Overall trial end date

01/11/2005

Reason abandoned

Eligibility

Participant inclusion criteria

Patients greater than 18 years with birch pollen allergy and hazelnut allergy

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

19

Participant exclusion criteria

1. Pregnancy
2. Significant concurrent disease
3. Instable asthma and oral medication with corticosteroids or beta-blocking agents

Recruitment start date

01/04/2004

Recruitment end date

01/11/2005

Locations

Countries of recruitment

Netherlands

Trial participating centre

University Medical Centre Utrecht
Utrecht
3508 GA
Netherlands

Sponsor information

Organisation

University Medical Centre Utrecht (UMCU) (The Netherlands)

Sponsor details

Department of Dermatology and Allergology
P.O. Box 85500
Utrecht
3508 GA
Netherlands
+31 (0)30 250 7388
info@umcutrecht.nl

Sponsor type

Hospital/treatment centre

Website

http://www.umcutrecht.nl

Funders

Funder type

Industry

Funder name

ALK-Abello BV (The Netherlands)

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