Allergic Rhinitis
Conditions
Brief summary
The purpose of this study is to examine in children with persistent AR the effect of the topically applied beclomethasone in comparison with cetirizine on nasal patency evaluated by acoustic rhinometry and subjective nasal symptoms.
Interventions
DRUGNasal Beclomethasone Dipropionate
Standard dose (400 µg/daily as 100 µg 1 spray nos bid) of nebulized Beclomethasone Dipropionate nasal spray for 21 days.
DRUGCERCHIO 10 mg/ml OS
For Children \< 12 years old 10 drops die (5 mg die) for 21 days. For Children \> 12 years old 20 drops die (10 mg die) for 21 days.
Sponsors
Stefania La Grutta, MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 16 Years
Healthy volunteers
No
Inclusion criteria
* children 6-16 years of age with a history of AR in the previous year * T5SS: ≥5 in the last week before enrollment
Exclusion criteria
* asthma symptoms * acute upper respiratory infections * anatomic nasal defects (ie, septum deviation), or nasal polyps * use in the past 4 weeks of nasal or oral corticosteroids, nasal or oral decongestants, antihistamines.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Nasal patency evaluated by acoustic rhinometry. | 21 days | The main objective is to assess the increase of nasal patency in children aged 6-16 with perennial allergic rhinitis (PAR), treated with Beclometasone nasal spray 100 µg/die for 21 days. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of Beclometasone nasal spray on subjective nasal symptoms | 21 days | The secondary objective is to measure the impact of Beclometasone nasal spray 100 µg on subjective nasal symptoms, in children aged 6-16 with perennial allergic rhinitis (PAR), assessed by T4SS Questionnaire(Total 4 Symptoms Score). |
Countries
Italy
Outcome results
None listed