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Symptomatic treatment of pollen related allergic rhinoconjunctivitis and the relation with asthma with children in the General practice

Completed
Conditions
Allergic Rhinoconjunctivitis and Hay Fever
10046304
Registration Number
NL-OMON41233
Lead Sponsor
Erasmus MC, Universitair Medisch Centrum Rotterdam
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
477
Inclusion Criteria

- Children aged 6-18 years
- Recruitment in general practice based on doctor*s diagnosis AR (ICPC R97) or prescription of allergy medication (antihistamines, INCS) in the last year.
- Sensitization to grass pollen or grass and tree pollen (determined by CAP-RAST, class >= 2).
- 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.
- Informed consent

Exclusion Criteria

- Use of INCS one month prior to randomization or antihistamines one week prior to randomization
- Currently pregnant or breastfeeding
- Spending a significant amount of time abroad during the study period
- Not able to speak and understand the Dutch language sufficiently
- Not having internet access to fill in the diary and questionnaires
- Contraindication determined by GP (problematic family situation, psychological problems or contra-indication for the medication)

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>Primary outcome: percentage of (nose and eye) symptom free days during the<br /><br>three month period (tree and grass pollen season). Above described outcomes<br /><br>will be analysed during the total period of 3 months, and during the separate<br /><br>tree pollen season (april 1st - may 15th) or grass pollen season (may 16h -<br /><br>june 30th).<br /><br><br /><br>Outcomes regarding the effectiveness of AR-treatment on asthma: degree of<br /><br>asthma control (defined by ACT)</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>Secondary outcomes: allergy symptom score, (rescue)medication free days,<br /><br>AR-specific quality of life, patient*s preference of medication. Above<br /><br>described outcomes will be analysed during the total period of 3 months, and<br /><br>during the separate tree pollen season (april 1st - may 15th) or grass pollen<br /><br>season (may 16h - june 30th).<br /><br><br /><br>Outcomes regarding the effectiveness of AR-treatment on asthma: degree of<br /><br>asthma control (defined by ACT), asthma symptom score, % days without asthma<br /><br>symptoms, asthma medication free days, asthma quality of life. </p><br>
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