Treatment of hay fever and the relation with asthma in children in de general practice office

• Conditions: Allergic RhinitisAsthma; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2012-001591-11-NL
• Lead Sponsor: Erasmus MC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07-19
• Last Update Posted: 7 January 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

Are the trial subjects under 18? yes
Number of subjects for this age range: 411
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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. <br>This study consists of two research questions: <br>Which treatment (antihistamines/INCS on demand/INCS continuously) is most effective in children with AR due to pollen allergy under treatment by the general practitioner? <br>What is the effectiveness of AR treatment on asthma symptoms and asthma control in patients with AR and concomitant asthma? <br>;Secondary Objective: not applicable;Primary end point(s): Research Question 1.<br>Percentage of (nose and eye) symptom free days during the tree and/or grass pollen season. <br>Research Question 2.<br>Asthma control.;Timepoint(s) of evaluation of this end point: Daily for diary questions or monthly for questionnaires

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Allergy symptom score, (rescue)medication free days, AR-specific quality of life, patient’s preference of medication. <br>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. <br>;Timepoint(s) of evaluation of this end point: Daily for diary questions or monthly for questionnaires