WheezingRSVchildNCT04689412
Nasal Resveratrol and Wheezing Episodes in Preschool Children
An observational study of Wheezing and Upper Respiratory Tract Infections, run by University Of Perugia at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 3 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Wheezing, Upper Respiratory Tract Infections
- What is being tested?
- Resveratrol
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 1 Apr 2018to 30 Apr 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Wheezing, Upper Respiratory Tract Infections
- Being tested
- Resveratrol
- Medical subject headings
- Respiratory Sounds, Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ResveratrolDrug
Nasal administration of resveratrol
| Study group | Role | What they receive |
|---|---|---|
| Cases | Children spontaneously treated with nasal resveratrol at the beginning of each upper airways infection Receives: Drug: Resveratrol | |
| Controls | Children spontaneously treated with nasal lavage at the beginning of each upper airways infection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wheezing days
number of wheezing days during the follow-up period
Measured: october 2017 - march 2018
Secondary outcomes (2)
Severity index
oral corticosteroid administration
Measured: october 2017 - march 2018
Severity index
access to ER or admission to pediatric ward
Measured: october 2017 - march 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2020
- Study start1 Apr 2018
- Primary completion31 Mar 2019
- Study completion30 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WheezingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Of Perugia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giuseppe Di Cara, PhD, MD, University Of Perugia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04689412
- Sponsor's protocol ID
- RSV01Ped
- Acronym
- RSVchild
- Status last verified
- Dec 2020
- First submitted
- 27 Dec 2020
- Last updated
- 30 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intermittent Treatment With Nasal Resveratrol and Reduction of Wheezing Episodes in Non Atopic Preschool Children
- ClinicalTrials.gov ID
- NCT04689412
- Acronym / sponsor ID
- RSVchild / RSV01Ped
- Conditions
- Wheezing, Upper Respiratory Tract Infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Of PerugiaUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 30 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | Drug: ResveratrolChildren spontaneously treated with nasal resveratrol at the beginning of each upper airways infection |
| Controls | – | –Children spontaneously treated with nasal lavage at the beginning of each upper airways infection |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Patients were selected from those referring to our centre for recurrent wheezing in the previous year.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ResveratrolNasal administration of resveratrol | Drug | Cases |
Primary outcome
Wheezing days
Time frame: october 2017 - march 2018
number of wheezing days during the follow-up period
2 secondary outcomes
Severity index
Time frame: october 2017 - march 2018
Severity index
Time frame: october 2017 - march 2018
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2020.
- Individual participant dataSharing planned: No
Related trials for Wheezing
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
Not yet recruitingPhase 4
Prevent Wheeze Trial
Lower Respiratory Tract Infection (LRTI), Recurrent Wheezing
RecruitingPhase 3
Protecting Preterm Infants From Respiratory Tract Infections and Wheeze by Using Bacterial Lysates.
Wheezing, LRTI
RecruitingObservational study
N-WATCH: Nottingham Wheeze Assessment in Tidal Children
Asthma in Children
Not yet recruitingPhase 1/2
Genes, Soy Isoflavones, and Virus
Wheezing
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wheezing and Upper Respiratory Tract Infections, run by University Of Perugia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wheezing days (time frame: october 2017 - march 2018). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2020.