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Nasal Resveratrol and Wheezing Episodes in Preschool Children (RSVchild)

27. desember 2020 oppdatert av: Giuseppe Di Cara, PhD, MD, University Of Perugia

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.

Studieoversikt

Status

Fullført

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Faktiske)

50

Kontakter og plasseringer

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Studiesteder

      • Perugia, Italia, 06100
        • Università di Perugia

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

3 år til 5 år (Barn)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Sannsynlighetsprøve

Studiepopulasjon

Patients were selected from those referring to our centre for recurrent wheezing in the previous year.

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
Cases
Children spontaneously treated with nasal resveratrol at the beginning of each upper airways infection
Nasal administration of resveratrol
Controls
Children spontaneously treated with nasal lavage at the beginning of each upper airways infection

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Wheezing days
Tidsramme: october 2017 - march 2018
number of wheezing days during the follow-up period
october 2017 - march 2018

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Severity index
Tidsramme: october 2017 - march 2018
oral corticosteroid administration
october 2017 - march 2018
Severity index
Tidsramme: october 2017 - march 2018
access to ER or admission to pediatric ward
october 2017 - march 2018

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. april 2018

Primær fullføring (Faktiske)

31. mars 2019

Studiet fullført (Faktiske)

30. april 2019

Datoer for studieregistrering

Først innsendt

27. desember 2020

Først innsendt som oppfylte QC-kriteriene

27. desember 2020

Først lagt ut (Faktiske)

30. desember 2020

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

30. desember 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

27. desember 2020

Sist bekreftet

1. desember 2020

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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