- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT04689412
Nasal Resveratrol and Wheezing Episodes in Preschool Children (RSVchild)
Intermittent Treatment With Nasal Resveratrol and Reduction of Wheezing Episodes in Non Atopic Preschool Children
As most of the upper airways infections (UAI) leading to wheezing are secondary to viral triggers, the possible antinflammatory and antiviral role of resveratrol has been suggested in several studies, both in vitro and in vivo. However, its efficacy has been studied only when evaluating upper respiratory symptoms.
With the aim to define new approaches in patients with recurrent wheezing triggered by UAI we have performed a prospective observational study to evaluate the efficacy of a short-course of intranasal resveratrol, administered for 7 days at the beginning of UAI, when compared to standard nasal lavage with 0.9% saline solution, in terms of reduction in wheezing episodes.
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
Patients Patients were selected from those referring to our centre for recurrent wheezing in the previous year.
The inclusion criteria were:
- Presence of at least 8 episodes of wheezing in the previous October-March period
- Negative skin prick test (SPT) for the most common allergens.
- Age less than 6 years
The exclusion criteria were:
- Sensitization to food allergens
- Sensitization to perennial allergens or to tree pollen allergens.
- Presence of atopic dermatitis
Patients were enrolled during visit 1, from April to August 2018, and were instructed to record symptoms of upper and lower airways during the wash-out period of September. During visit 2 at the end of September patients were randomized into 2 groups:
- group 1: patients treated with 0.9% saline solution daily nasal lavage
- group 2: patients treated with 0.9% saline solution daily nasal lavage and a 7-days therapy with nasal resveratrol, from the beginning of upper airways symptoms.
All patients were followed from September 2018 to the end of March 2019, with visit 3 and 4 after two (end of November) and four months (end of January). Follow-up ended with visit 5 at the end of March. All patients were instructed to register in specifically designated charts the number of days with symptoms of upper airways inflammation and the recurrence of wheezing. As predictive index of disease severity, parents were instructed to register both days with oral corticosteroids administration (OCA) and with hospitalization need, as ER occurrence or admission to paediatric wards. All patient were instructed to treat each wheezing episode with inhaled salbutamol and, if wheezing persisted, with oral prednisolone once a day, according to guidelines (Gina 2015).
Skin prick tests The sensitization status of each patient was assessed by performing skin prick tests (SPTs) with a standard panel of environmental (Stallergenes, Antony, France) and food allergens (Lofarma, Milan, Italy). Positivity of SPT was established according to the guidelines of the European Academy of Allergology and Clinical Immunology. The standard panel of allergens included Phleum pratense, Parietaria judaica, Juniperus ashei, Olea europaea, Dermatophagoides pteronyssinus, Alternaria tenuis, cat and dog epithelium; milk, egg, peanut, tree nuts, fish, shellfish, soy, and wheat plus a positive (histamine 10 mg/mL) and a negative (normal saline) control. Wheals were contoured with a soft pen and transferred onto cellotape. A skin reaction of 5 mm was considered the threshold for positivity.
Clinical symptoms, rescue medication and severity evaluation During the evaluation period, patients filled in daily diary cards to record days with symptoms involving the upper (sneezing, rhinorrhoea, itching and nasal blockage) and lower airways (cough, dyspnoea and wheezing), the use of oral corticosteroids (OCS) and the days of hospitalization when occurred.
Typ studiów
Zapisy (Rzeczywisty)
Kontakty i lokalizacje
Lokalizacje studiów
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Perugia, Włochy, 06100
- Universita di Perugia
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Metoda próbkowania
Badana populacja
Opis
The inclusion criteria were:
- Presence of at least 8 episodes of wheezing in the previous October-March period
- Negative skin prick test (SPT) for the most common allergens.
- Age less than 6 years
The exclusion criteria were:
- Sensitization to food allergens
- Sensitization to perennial allergens or to tree pollen allergens.
- Presence of atopic dermatitis
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
Kohorty i interwencje
Grupa / Kohorta |
Interwencja / Leczenie |
---|---|
Cases
Children spontaneously treated with nasal resveratrol at the beginning of each upper airways infection
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Nasal administration of resveratrol
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Controls
Children spontaneously treated with nasal lavage at the beginning of each upper airways infection
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
Wheezing days
Ramy czasowe: october 2017 - march 2018
|
number of wheezing days during the follow-up period
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october 2017 - march 2018
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
Severity index
Ramy czasowe: october 2017 - march 2018
|
oral corticosteroid administration
|
october 2017 - march 2018
|
Severity index
Ramy czasowe: october 2017 - march 2018
|
access to ER or admission to pediatric ward
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october 2017 - march 2018
|
Współpracownicy i badacze
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- RSV01Ped
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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Badania kliniczne na Resveratrol
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Sun Yat-sen UniversityZakończony
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Khoo Teck Puat HospitalNational Medical Research Council (NMRC), SingaporeZakończony