Bronchial SpasmPhase 4ENBeNCT01265342
Efficacy of Nebulised Beclometasone in Viral Wheezing Prophylaxis
A Phase 4 study testing Beclomethasone in people with Bronchial Spasm and Respiratory Sounds, run by Mario Negri Institute for Pharmacological Research at 9 sites in Italy.
Trial summary
Inhaled steroids, in particular beclomethasone, are widely prescribed in Italy as symptomatic treatment of upper respiratory infections without evidence of efficacy. The purpose of this study is to evaluate the efficacy of beclomethasone (administered by nebuliser twice a day) in preventing viral wheezing in… Read more about this study
- Who is it for?
- Ages 12 to 71 months
- Conditions the study is for
- Bronchial Spasm, Respiratory Sounds, Respiratory Tract Infections
- What is being tested?
- Beclomethasone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 576 participants
- Where
- 9 sitesItaly
- Study dates
- Oct 2010to Oct 2012
- Phase
- Phase 4
- 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 12 to 71 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Outpatient children 1-5 years old
- Presence of any viral upper respiratory tract infection symptoms
- At least one episode of viral wheezing (diagnosed by a physician) in the last 12 months.
- No, or minimal, asthma-like symptoms in between separate airway infections
Who cannot join
- Steroid hypersensitivity
- Inhaled and/or oral corticosteroid use in the preceding month
- Chronic respiratory disease (e.g. cystic fibrosis, broncho-pulmonary dysplasia)
- Presence of wheezing at the entry visit
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Italy9 sites
ASL NA/3 Sud
Castellammare di Stabia
AUSL Chieti
Chieti
ASL Monza Brianza
Monza
ASL Torino 3
Pinerolo
ASP di Reggio Calabria
Reggio Calabria
Ausl Roma E
Roma
AUSL Taranto
Taranto
Azienda ULSS 20 Verona
Verona
ASL 12
Viareggio
About this study
Official title: Efficacy Of Nebulised Beclometasone Versus Placebo In Preventing Viral Wheezing In Pre-School Children
Inhaled steroids, in particular beclomethasone, are widely prescribed in Italy as symptomatic treatment of upper respiratory infections without evidence of efficacy.
The purpose of this study is to evaluate the efficacy of beclomethasone (administered by nebuliser twice a day) in preventing viral wheezing in pre-school children who had had episodes in the preceding 12 months.
Read the detailed description
Viral wheezing (intermittent episodes of wheezing induced by viral infection of the upper respiratory tract) is a common condition in pre-school children. Its incidence is estimated between 6 and 30% and varies depending on criteria, diagnosis, and age definition used. Viral wheezing, however, is different from atopic asthma, since in 60% of cases symptoms disappear before the age of 6 . The efficacy of drug treatments in the prevention and/or treatment of viral wheezing is controversial; short acting beta 2 agonists are often considered first choice therapies even if evidence is scarce The usefulness of inhaled steroids is also debated: no benefits are documented for maintenance with low dose inhaled corticosteroids, while their episodic use at a high dose may have a modest improvement in symptoms. Despite the scant evidence, however, nebulised steroids in particular beclomethasone, are widely prescribed in Italy as prophylaxis or treatment for viral wheezing. Beclometasone is the third most prescribed drug in Italian children, with a prevalence estimated around 15% A randomized placebo-controlled trial was therefore planned to evaluate the effectiveness of nebulised beclometasone in preventing viral wheezing in children with upper respiratory tract infections. Besides investigating the drug efficacy, the study could also monitor the incidence of viral wheezing recurrence in preschool children, the disease's natural history and the different therapeutic approaches used by the physicians.
The study will involve 36 Italian family paediatricians from 9 local health units. Children will be randomized to receive beclomethasone or placebo.
The treatment period will last 10 days, and it will be followed by an observational 6 month follow-up period.
Three visits are scheduled: the first at baseline, the second at the end of the treatment period and the third at the end of follow-up period.
During the 10 day treatment period, symptoms will be recorded by the parents on a diary. A clinical evaluation will be performed by the paediatrician during the entry visit and at the end of the treatment period. Moreover, parents will be requested to contact the paediatrician if wheezing occurs during the treatment period and/or the child does not improve within 72 hours from the start of the therapy.
In case of wheezing and/or lack of improvement, paediatricians should visit the child, evaluate the presence of wheezing and rate it. A wheeze score will be assigned as follows: 0 = no wheezing, 1 = end-expiratory wheeze only, 2 = wheeze during entire expiratory with or without inspiratory phase, audible with stethoscope only, 3 = inspiratory and expiratory wheezing audible without stethoscope.
- Being tested
- Beclomethasone, Placebo
- Keywords
- Bronchial Spasm, Respiratory Tract Infections, Viral wheezing, Child, Preschool, Beclomethasone, Italy, Physicians, Primary Care, Pediatrics
- Medical subject headings
- Bronchial Spasm, Respiratory Sounds, Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BeclomethasoneDrug
Beclomethasone nebulised suspension 400 micrograms twice a day for 10 days
PlaceboDrug
Placebo nebulised suspension twice a day for 10 days
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Beclomethasone | Experimental | Beclometasone suspension 400 mcg will be administered through a nebuliser twice a day, in the morning and in the evening, for 10 days Receives: Drug: Beclomethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
% of children with wheezing (diagnosed by the paediatrician) during the URTI episode.
Secondary outcomes (12)
% of patients needing medical care during the treatment period;
% of patients receiving rescue medication during the treatment period;
% of patients admitted to an emergency department during the treatment period
Duration of the respiratory tract infection episode
% of patients with an asthma-like symptom score (rated by parents) >= 7
Mean asthma-like symptom score for each child
Time to the first viral wheezing episode after the end of the treatment
Frequency of respiratory tract infection episodes during the 6 month follow-up period
Frequency of viral wheezing episodes during the 6 month follow-up period
% of parents who consider the treatment helpful
% of patients fully adherent to therapy
average cost per patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2010 (estimated)
- Study startOct 2010
- Primary completionMar 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bronchial SpasmStudies of the same condition, open and under way.
- More trials run by Mario Negri Institute for Pharmacological ResearchThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 576 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Agenzia Italiana del Farmaco, Associazione Culturale Pediatri
- Responsible party
- Sponsor
- Investigators
- Antonio Clavenna, MD, Principal investigator, Mario Negri Institute for Pharmacological Research, Milan, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01265342
- Sponsor's protocol ID
- FARM7RANLZ
- Other IDs
- 2009-011116-38, 2009
- Acronym
- ENBe
- Status last verified
- Mar 2014
- First submitted
- 22 Dec 2010
- Last updated
- 11 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Clavenna A, Sequi M, Cartabia M, Fortinguerra F, Borghi M, Bonati M; ENBe Study Group. Effectiveness of nebulized beclomethasone in preventing viral wheezing: an RCT. Pediatrics. 2014 Mar;133(3):e505-12. doi: 10.1542/peds.2013-2404. Epub 2014 Feb 17.
PubMed 24534400
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Of Nebulised Beclometasone Versus Placebo In Preventing Viral Wheezing In Pre-School Children
- ClinicalTrials.gov ID
- NCT01265342
- Acronym / sponsor ID
- ENBe / FARM7RANLZ
- Keywords
- Bronchial Spasm, Respiratory Tract Infections, Viral wheezing, Child, Preschool, Beclomethasone, Italy, Physicians, Primary Care, Pediatrics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 576 participants (estimated)
- Lead sponsor
- Mario Negri Institute for Pharmacological ResearchUniversity, hospital or other
- Collaborators
- Agenzia Italiana del Farmaco, Associazione Culturale Pediatri
- Study start
- Oct 2010
- Primary completion
- Mar 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 23 Dec 2010 (estimated)
- 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.
Inhaled steroids, in particular beclomethasone, are widely prescribed in Italy as symptomatic treatment of upper respiratory infections without evidence of efficacy.
The purpose of this study is to evaluate the efficacy of beclomethasone (administered by nebuliser twice a day) in preventing viral wheezing in pre-school children who had had episodes in the preceding 12 months.
Detailed description
Viral wheezing (intermittent episodes of wheezing induced by viral infection of the upper respiratory tract) is a common condition in pre-school children. Its incidence is estimated between 6 and 30% and varies depending on criteria, diagnosis, and age definition used. Viral wheezing, however, is different from atopic asthma, since in 60% of cases symptoms disappear before the age of 6 . The efficacy of drug treatments in the prevention and/or treatment of viral wheezing is controversial; short acting beta 2 agonists are often considered first choice therapies even if evidence is scarce The usefulness of inhaled steroids is also debated: no benefits are documented for maintenance with low dose inhaled corticosteroids, while their episodic use at a high dose may have a modest improvement in symptoms. Despite the scant evidence, however, nebulised steroids in particular beclomethasone, are widely prescribed in Italy as prophylaxis or treatment for viral wheezing. Beclometasone is the third most prescribed drug in Italian children, with a prevalence estimated around 15% A randomized placebo-controlled trial was therefore planned to evaluate the effectiveness of nebulised beclometasone in preventing viral wheezing in children with upper respiratory tract infections. Besides investigating the drug efficacy, the study could also monitor the incidence of viral wheezing recurrence in preschool children, the disease's natural history and the different therapeutic approaches used by the physicians.
The study will involve 36 Italian family paediatricians from 9 local health units. Children will be randomized to receive beclomethasone or placebo.
The treatment period will last 10 days, and it will be followed by an observational 6 month follow-up period.
Three visits are scheduled: the first at baseline, the second at the end of the treatment period and the third at the end of follow-up period.
During the 10 day treatment period, symptoms will be recorded by the parents on a diary. A clinical evaluation will be performed by the paediatrician during the entry visit and at the end of the treatment period. Moreover, parents will be requested to contact the paediatrician if wheezing occurs during the treatment period and/or the child does not improve within 72 hours from the start of the therapy.
In case of wheezing and/or lack of improvement, paediatricians should visit the child, evaluate the presence of wheezing and rate it. A wheeze score will be assigned as follows: 0 = no wheezing, 1 = end-expiratory wheeze only, 2 = wheeze during entire expiratory with or without inspiratory phase, audible with stethoscope only, 3 = inspiratory and expiratory wheezing audible without stethoscope.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| Beclomethasone | Experimental | Drug: BeclomethasoneBeclometasone suspension 400 mcg will be administered through a nebuliser twice a day, in the morning and in the evening, for 10 days |
Who may qualify
- Ages
- 12 to 71 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Outpatient children 1-5 years old
- Presence of any viral upper respiratory tract infection symptoms
- At least one episode of viral wheezing (diagnosed by a physician) in the last 12 months.
- No, or minimal, asthma-like symptoms in between separate airway infections
Key exclusion criteria (4 listed)
- Steroid hypersensitivity
- Inhaled and/or oral corticosteroid use in the preceding month
- Chronic respiratory disease (e.g. cystic fibrosis, broncho-pulmonary dysplasia)
- Presence of wheezing at the entry visit
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 |
|---|---|---|
| BeclomethasoneBeclomethasone nebulised suspension 400 micrograms twice a day for 10 days | Drug | Beclomethasone |
| PlaceboPlacebo nebulised suspension twice a day for 10 days | Drug | Placebo |
Primary outcome
% of children with wheezing (diagnosed by the paediatrician) during the URTI episode.
12 secondary outcomes
% of patients needing medical care during the treatment period;
% of patients receiving rescue medication during the treatment period;
% of patients admitted to an emergency department during the treatment period
Duration of the respiratory tract infection episode
% of patients with an asthma-like symptom score (rated by parents) >= 7
Mean asthma-like symptom score for each child
Time to the first viral wheezing episode after the end of the treatment
Frequency of respiratory tract infection episodes during the 6 month follow-up period
Frequency of viral wheezing episodes during the 6 month follow-up period
% of parents who consider the treatment helpful
% of patients fully adherent to therapy
average cost per patient
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 11 Mar 2014.
- Results publication: PubMed 24534400Clavenna A, Sequi M, Cartabia M, Fortinguerra F, Borghi M, Bonati M; ENBe Study Group. Effectiveness of nebulized beclomethasone in preventing viral wheezing: an RCT. Pediatrics. 2014 Mar;133(3):e505-12. doi: 10.1542/peds.2013-2404. Epub 2014 Feb 17.
Related trials for Bronchial Spasm
RecruitingPhase 3
A Study to Compare Safety of 4 Weeks Exposure to Propellants Hydrofluoroalkane 1,1-difluoroethane (HFA-152a) and HFA-1,1,1,2-tetrafluoroethane (134a)
Asthma
Not yet recruitingObservational study
Perioperative Respiratory Adverse Events in Cleft Lip and Palate Surgery: Incidence, Risk Factors, and Clinical Scoring
Cleft Palate, Cleft Lip
RecruitingObservational study
Swiss Paediatric Airway Cohort
Asthma, Wheezing
Recruiting
Driving Pressure During Surgeries With High Risk for Postoperative Pulmonary Complications
Postoperative Pulmonary Atelectasis, Postoperative Pulmonary Complications
Recruiting
Intraoperative Paravertebral Block and Postoperative Complications
Video-assisted Thoracoscopic Surgery (VATS), Lung Cancer (Diagnosis)
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.
Antonio Clavenna, MD principal investigator
Mario Negri Institute for Pharmacological Research, Milan, Italy
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Beclomethasone in people with Bronchial Spasm and Respiratory Sounds, run by Mario Negri Institute for Pharmacological Research at 9 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. 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 11 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
% of children with wheezing (diagnosed by the paediatrician) during the URTI episode.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01265342, which also lists 1 linked publication.
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 11 Mar 2014.