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Treatment of hay fever in relation to asthma, in children.

Symptomatic treatment of allergic rhinoconjunctivitis and the relation with asthma in children.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON26975
Enrollment
477
Registered
2012-05-11
Start date
2012-09-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic Rhinitis (allergische rinitis) Asthma (astma)

Interventions

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.

Sponsors

Erasmuc MC, Rotterdam
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Children aged 6-18 years; 2. Recruitment in general practice based on doctor’s 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

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. 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)

Design outcomes

Primary

MeasureTime frame
Percentage of (nose and eye) symptom free days during 3 months in the tree/grass pollen season.

Secondary

MeasureTime frame
1. Allergy symptom score; 2. (Rescue)medication free days; 3. AR-specific quality of life; 4. Patient’s 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.

Contacts

Public ContactJ.B. Wartna

Afdeling huisartsgeneeskunde Erasmus MC Intern adres: GK 1048 Postbus 2040

j.wartna@erasmusmc.nl+31 (0)10 7043550

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)