Università di Perugia
Perugia, 06100, Italy
NCT Number: NCT04689412
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.
Looking for future studies?
Notify Me3 year–5 year
All sexes
Observational
Perugia, 06100, Italy
Patients Patients were selected from those referring to our centre for recurrent wheezing in the previous year.
The inclusion criteria were:
The exclusion criteria were:
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:
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
The inclusion criteria were:
The exclusion criteria were:
Nasal administration of resveratrol
Time frame: october 2017 - march 2018
number of wheezing days during the follow-up period
Time frame: october 2017 - march 2018
oral corticosteroid administration
Time frame: october 2017 - march 2018
access to ER or admission to pediatric ward
University Of Perugia
Other
Intermittent Treatment With Nasal Resveratrol and Reduction of Wheezing Episodes in Non Atopic Preschool Children
Acronym: RSVchild
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.
Published trials that share one or more normalized conditions with this study.
NCT05064631
Bronchial Diseases, Bronchiolitis
London, United Kingdom
View Trial DetailsNCT03741322
Infections, Pathological Conditions, Signs and Symptoms
Durham, North Carolina, United States
View Trial DetailsNCT06201494
Asthma, Asthma in Children
Prague, Czechia
View Trial DetailsNCT06570889
Allergy, Asthma
Gentofte Municipality, Denmark
View Trial Details