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Completed

NCT Number: NCT02130440

Evaluation of the Beneficial Effects of a Nasal Spray of Resveratrol in Children With Seasonal Allergic Rhinitis

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.

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Key information

Conditions

Seasonal Allergic Rhinitis Airway Obstruction Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Infections Nasal Obstruction Nose Diseases Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Pruritus Respiration Disorders Respiratory Hypersensitivity Respiratory Insufficiency Respiratory Sounds Respiratory Tract Diseases Respiratory Tract Infections Rhinitis Rhinitis, Allergic Rhinitis, Allergic, Seasonal Rhinorrhea Signs and Symptoms Signs and Symptoms, Respiratory Skin Diseases Skin Manifestations Skin and Connective Tissue Diseases Sneezing

Age range

4 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Second University of Naples

Naples, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Resveratrol nasal spray

Drug

Primary outcomes

  1. Nasal symptom severity

    Time frame: 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 outcomes

  1. Cough

    Time frame: 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.

  2. Wheezing

    Time frame: two year

    Wheezing will be assessed using the same four-point scale and record by parents on a daily diary card.

  3. Albuterol use

    Time frame: two years

    The albuterol use on demand will be record by parents on a daily diary card.

  4. Fever

    Time frame: two years

    The days with fever will be record by parents on a daily diary card.

  5. School absences

    Time frame: two years

    School absences will be record by a diary card.

  6. Antihistamines use

    Time frame: two years

    Evaluation of Cetirizine syrup on-demand use will be record by parents on a diary card

  7. Emergency visits

    Time frame: two years

    Emergency room visits for respiratory problems will be record by parents on a diary card.

Sponsors and collaborators

Lead sponsor

University of Campania Luigi Vanvitelli

Other

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
May 5, 2014
Registry last updated
May 5, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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