Sublingual immunotherapy with house dust mite allergen in children with allergic rhinitis: randomised double-blind placebo-controlled trial

ISRCTN	ISRCTN91141483
DOI	https://doi.org/10.1186/ISRCTN91141483
Secondary identifying numbers	NTR385

Submission date: 19/12/2005
Registration date: 19/12/2005
Last edited: 27/10/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr H. Moed
Scientific

Erasmus Medical Center
Department of General Practice
PO Box 2040
Rotterdam
3000 CA
Netherlands

Phone	+31 (0)10 704 4194
Email	h.moed@erasmusmc.nl

Study information

Study design	Randomised double blind placebo controlled parallel group trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title	Sublingual immunotherapy with house dust mite allergen in children with allergic rhinitis: randomised double-blind placebo-controlled trial
Study acronym	STARDROP II
Study objectives	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(s)	Ethics approval received from the Ethical Review Board of Erasmus Medical Centre on the 13th September 2005.
Health condition(s) or problem(s) studied	Rhinitis, allergy, house dust mite
Intervention	Sublingual immunotherapy (SLIT) with house dust mite allergen for 24 - 26 months. Control: placebo.
Intervention type	Other
Primary outcome measure	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 study start date	19/09/2005
Completion date	31/12/2008

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	6 Years
Upper age limit	18 Years
Sex	Not Specified
Target number of participants	256
Total final enrolment	251
Key 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
Key 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
Date of first enrolment	19/09/2005
Date of final enrolment	31/12/2008

Locations

Countries of recruitment

Netherlands

Study participating centre

Erasmus Medical Center

Rotterdam
3000 CA
Netherlands

Sponsor information

Artu Biologicals Europe B.V. (Netherlands)
Industry

Vijzelweg 11
Lelystad
8243 PM
Netherlands

Phone	+31 (0)320-267900
Email	info@artu-biologicals.com
"ROR"	https://ror.org/022w0b336

Funders

Funder type

Industry

Added on 03/07/2008:

No information available

Artu Biologicals Europe B.V. (Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	20/10/2008		Yes	No
Results article		01/03/2012	27/10/2022	Yes	No

Editorial Notes

27/10/2022: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.