|- candidate number||12371|
|- NTR Number||NTR3429|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||11-mei-2012|
|- Secondary IDs||3.4.11.049 Astma Fonds|
|- Public Title||Treatment of hay fever in relation to asthma, in children.|
|- Scientific Title||Symptomatic treatment of allergic rhinoconjunctivitis and the relation with asthma in children.|
|- Healt Condition(s) or Problem(s) studied||Allergic rhinitis, Asthma|
|- Inclusion criteria||1. Children aged 6-18 years;|
2. Recruitment in general practice based on doctorís diagnosis AR (ICPC R97) or prescription of allergy medication (antihistamines, INCS) in the past;
3. Sensitization to grass and/or tree pollen (determined by CAP-RAST, class >= 2);
4. Present symptoms of allergic rhinitis and conjunctivitis. Severity will be determined by a retrospective symptom score (patients have to recall their complaints during the previous hay fever season). Seven complaints of nose (sneezing, nose blockage, runny nose, itching nose) and eye (itching eyes, redness and tearing eyes), will be determined. Each symptom is recorded on a scale from 0 to 3. A minimum of 7 out of the maximum of 21 points is required to be included in the study.
|- Exclusion criteria||1. Use of INCS one month prior to randomization or antihistamines one week prior to randomization;|
2. Currently pregnant or breastfeeding;
3. Spending a significant amount of time abroad during the study period;
4. Not be able to speak and understand the Dutch language sufficiently for both parents as the patients.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-sep-2012|
|- planned closingdate||1-sep-2014|
|- Target number of participants||477|
|- Interventions||Children will receive medication for a period of 1,5 or 3 months (depending on sensibilisation-type) during the hay fever season. This medication can be taken in three different schedules:|
1. Xyzal, 5mg, if necessary;
2. Flixonase, 50mcg, 1 or 2 sprays a day in each nostril, when necessary;
3. Flixonase, 50mcg, 1 or 2 sprays in each nostril, daily.
A diary and several questionnaires have to be filled in.
|- Primary outcome||Percentage of (nose and eye) symptom free days during 2 months in the tree/grass pollen season.|
|- Secondary outcome||1. Allergy symptom score;|
2. (Rescue)medication free days;
3. AR-specific quality of life;
4. Patientís preference of medication.
Outcomes regarding the effectiveness of AR-treatment on asthma: % days without asthma symptoms, asthma symptom score, asthma medication free days, asthma quality of life, and degree of asthma control.
|- Timepoints||Patients have to fill in a diary on a daily basis for 1,5 or 3 months (depending on their type of allergy). During this 1,5 or 3 months several questionnaires will be conducted. The measure points will be at the start, halfway (3 weeks or 6 weeks) and at the end of the study. |
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| J.B. Wartna|
|- CONTACT for SCIENTIFIC QUERIES|| J.B. Wartna|
|- Sponsor/Initiator ||Erasmus Medical Center|
(Source(s) of Monetary or Material Support)
|Longfonds The Netherlands |
|- Brief summary||Therapeutic intervention for mild or intermittent AR includes antihistamines or intranasal corticosteroids (INCS). Both types of drug have certain benefits and it is unclear which of the two are more effective and preferred by younger patients (children aged 6 to 18 years old). Besides, the patients tend to use INCS when they have complaints instead of continuously during the hay fever season, as prescribed by the GP. This could also influence the effectiveness of INCS.
Allergic rhinitis (AR) and asthma are considered manifestations of the same origin affecting different parts of the respiratory tract. It has been suggested that adequate treatment of AR might be beneficial for the lower airways. Whereas INCS and perhaps antihistamines may be a promising additive treatment to reduce asthma symptoms in patients with rhinitis and mild asthma, more research is needed.
In this randomized controlled singleblind trail we will select children (6-18 years old) with seasonal AR (hay fever) under treatment by the general practitioner. During the hay fever season children will get either antihistamines on demand, INCS on demand or INCS continuously. We will compare the percentage of (nose and eye) symptom free days during the pollen season and the effect of treatment on asthma symptoms and control.|
|- Main changes (audit trail)||27-jan-2015: Changes due to METC approval: |
- Addition of following exclusion criteria:
5. Not having internet access to fill in the diary and questionnaires
6. Contraindication determined by GP (problematic family situation, psychological problems or
contra-indication for the medication)
- Intervention changed into: "Children will receive medication for a period of 3 months during the hay fever season. This medication can be taken in three different schedules:
1. Levocetrizine, 5mg, if necessary;
2. Fluticason, 50mcg, 1 or 2 sprays a day in each nostril, when necessary;
3. Fluticason, 50mcg, 1 or 2 sprays in each nostril, daily.
- Primary outcome: "Percentage of (nose and eye) symptom free days during 3 months in the tree/grass pollen season."
- Timepoints: "Patients have to fill in an online diary on a daily basis for 3 months. During these 3 months several questionnaires will be conducted. The measure points will be at the start, halfway ( 6 weeks) and at the end of the study."
|- RECORD||11-mei-2012 - 28-jan-2015|