Condition category
Respiratory
Date applied
19/12/2005
Date assigned
19/12/2005
Last edited
10/09/2009
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 H. Moed

ORCID ID

Contact details

Erasmus Medical Center
Department of General Practice
PO Box 2040
Rotterdam
3000 CA
Netherlands
+31 (0)10 704 4194
h.moed@erasmusmc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR385

Study information

Scientific title

Acronym

STARDROP II

Study hypothesis

Null hypothesis:
Sublingual immunotherapy with house dust mite allergen is as effective as placebo on daily symptoms in children with allergic rhinitis.

Please note that as of 03/07/2008 more details on the sources of funding have been added to this record. This can be seen below in the sources of funding section.

Ethics approval

Ethics approval received from the Ethical Review Board of Erasmus Medical Centre on the 13th September 2005.

Study design

Randomised double blind placebo controlled parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Rhinitis, allergy, house dust mite

Intervention

Sublingual immunotherapy (SLIT) with house dust mite allergen for 24 - 26 months.
Control: placebo.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Mean rhinitis symptom score in September - December after 2 years of SLIT/placebo.

Secondary outcome measures

All in September - December after 2 years of SLIT/placebo, except last outcome below:
1. Proportion of symptom free days
2. Proportion of days without rescue medication
3. Mean eye symptom score
4. Total symptom score
5. Rhinitis specific quality of life questionnaire (PARQLQ)
6. Overall assessment of perceived benefit by child and parent over whole period

Overall trial start date

19/09/2005

Overall trial end date

31/12/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age: 6 - 18 years
2. History of allergic rhinitis for at least one year
3. Positive RAST for house dust mite allergy (Y2+)
4. No use of nasal steroids in month before start of baseline measurements
5. Symptom score of at least 4/12 (four nasal symptoms with scores ranging 0 - 3)
6. Informed consent

Participant type

Patient

Age group

Child

Gender

Not Specified

Target number of participants

256

Participant exclusion criteria

1. Severe asthma
2. Allergic sensitivity to pets, in case these are present in the family home
3. Planned surgery of nasal cavity in the course of the study
4. Having received immunotherapy in past three years
5. Contraindications to sublingual immunotherapy

Recruitment start date

19/09/2005

Recruitment end date

31/12/2008

Locations

Countries of recruitment

Netherlands

Trial participating centre

Erasmus Medical Center
Rotterdam
3000 CA
Netherlands

Sponsor information

Organisation

Artu Biologicals Europe B.V. (Netherlands)

Sponsor details

Vijzelweg 11
Lelystad
8243 PM
Netherlands
+31 (0)320-267900
info@artu-biologicals.com

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Added on 03/07/2008:

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Artu Biologicals Europe B.V. (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

2008 protocol in http://www.ncbi.nlm.nih.gov/pubmed/18937864

Publication citations

  1. Protocol

    de Bot CM, Moed H, Berger MY, Röder E, de Groot H, de Jongste JC, van Wijk RG, van der Wouden JC, Randomized double-blind placebo-controlled trial of sublingual immunotherapy in children with house dust mite allergy in primary care: study design and recruitment., BMC Fam Pract, 2008, 9, 59, doi: 10.1186/1471-2296-9-59.

Additional files

Editorial Notes