Seasonal Allergic Rhinitis
Conditions
Keywords
nasal obstruction, sneezing, itching, rhinorrhea, respiratory infections, wheezing
Brief summary
The aim of this study is to evaluate whether treatment with a nasal spray based on resveratrol has some benefit in patients with seasonal allergic rhinitis, mild, moderate, or severe.
Detailed description
The aim of this study is to evaluate whether treatment with a nasal spray based on resveratrol has some benefit in patients with seasonal allergic rhinitis, mild, moderate, or severe. The primary objective is to assess whether the treatment with nasal spray based resveratrol is able to improve the allergic rhinitis symptoms during the two months of treatment. The secondary aim is to evaluate if the resveratrol nasal spray is able to reduce respiratory infections and wheezing episodes.
Interventions
DRUGResveratrol nasal spray
Sponsors
University of Campania Luigi Vanvitelli
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
4 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Children of both sexes, ranging in age from 4 to 17 years * History of seasonal allergic rhinitis, mild, moderate or severe, defined according to the ARIA guidelines in 2010, documented by recurrent episodes in the previous year and confirmed by a positive skin test results * Written informed consent from at least one parent or a legal representative
Exclusion criteria
* Lack of informed consent in writing by at least one parent or a legal representative * Concomitant disorders, such as infection of the upper (sinusitis, etc..) or lower respiratory tract, nasal surgery in the last year, abnormalities of the respiratory tract, immune diseases * Use of antihistamines, nasal or systemic corticosteroids, leukotriene modifiers, cromolyn sodium, in the last six weeks
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Nasal symptom severity | two years | Nasal symptoms (itching, sneezing, rhinorrhea, and obstruction) will be scored by a four-point scale (0=no symptom; 1=mild; 2= moderate; 3= severe) and record by parents on a daily diary card. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Wheezing | two year | Wheezing will be assessed using the same four-point scale and record by parents on a daily diary card. |
| Albuterol use | two years | The albuterol use on demand will be record by parents on a daily diary card. |
| Fever | two years | The days with fever will be record by parents on a daily diary card. |
| Cough | two years | The cough presence and severity will be assessed during the day and the night by four-point scale and recorded by parents on a daily diary card. |
| Antihistamines use | two years | Evaluation of Cetirizine syrup on-demand use will be record by parents on a diary card |
| Emergency visits | two years | Emergency room visits for respiratory problems will be record by parents on a diary card. |
| School absences | two years | School absences will be record by a diary card. |
Countries
Italy
Outcome results
None listed