WheezingPhase 4NCT02381158
Nebulized Beclomethasone Dipropionate Improves Respiratory Lung Function in Preschool Children With Recurrent Wheezing
A Phase 4 study testing Nebulized beclomethasone dipropionate in people with Wheezing, run by Istituto per la Ricerca e l'Innovazione Biomedica.
Trial summary
This is a single-centre, open label study, aiming to evaluate the efficacy of beclomethasone dipropionate applied for 12 weeks with a dose of 400 µg twice a day (total dose 800 µg nebulized), on airway resistance and reactances (measured with Rint and FOT techniques) in children with recurrent wheezing, aged 2-5… Read more about this study
- Who is it for?
- Ages 2 to 5 years
- Conditions the study is for
- Wheezing
- What is being tested?
- Nebulized beclomethasone dipropionate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Feb 2015to Dec 2015
- 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 2 to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Informed and subscribed consent before any procedure
- Age range : 2 - ≤5 years
- Male and female patients
- Recurrent wheezing affected ( ≥ 4 episodes in the last 12 months)
- PAI positive (at least one primary and two secondary ):
- Primary:
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- one parent with asthma
- Atopic Dermatitis
- sensibilisation to air allergen
- Secondary:
- Food sensibilization
- wheezing also not during the infective episodes
- eosinophilia (>4%)
Who cannot join
- story of severe wheeze requiring hospitalization
- treatment with inhaled glucocorticoids during the previous 4 weeks or with oral glucocorticoids in the previous 8 weeks
- structural abnormalities of the lungs (tracheobronchial bronchomalacia, external compressions, etc)
- Persistent infections
- aspiration lung disease (gastroesophageal reflux disease, etc.)
- Cystic fibrosis
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- prematurity or bronchopulmonary dysplasia
- Tuberculosis
- primary ciliary dyskinesia
- congenital heart disease
- pulmonary foreign body
- bronchiectasis
- Immunodeficit
About this study
This is a single-centre, open label study, aiming to evaluate the efficacy of beclomethasone dipropionate applied for 12 weeks with a dose of 400 µg twice a day (total dose 800 µg nebulized), on airway resistance and reactances (measured with Rint and FOT techniques) in children with recurrent wheezing, aged 2-5 years. In addition, clinic score as frequency of symptoms and exacerbations, will be assessed.
- Conditions
- Wheezing
- Being tested
- Nebulized beclomethasone dipropionate
- Keywords
- Wheezing, Children
- Medical subject headings
- Respiratory Sounds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nebulized beclomethasone dipropionateDrug
Also called BDP
Nebulized beclomethasone dipropionate applied for 12 weeks with a dose of 400 µg twice a day (total dose 800 µg)
| Study group | Role | What they receive |
|---|---|---|
| Nebulized Beclomethasone dipropionate | Experimental | Nebulized Beclomethasone dipropionate applied for 12 weeks with a dose of 400 µg twice a day (total dose 800 µg). Receives: Drug: Nebulized beclomethasone dipropionate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung fuction with Rint and FOT
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2015 (estimated)
- Study startFeb 2015
- Primary completionDec 2015
- Study completionDec 2015
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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto per la Ricerca e l'Innovazione Biomedica
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefania La Grutta, MD, Istituto per la Ricerca e l'Innovazione Biomedica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02381158
- Sponsor's protocol ID
- 0000573
- Status last verified
- Jan 2017
- First submitted
- 12 Feb 2015
- Last updated
- 20 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nebulized Beclomethasone Dipropionate Improves Respiratory Lung Function in Preschool Children With Recurrent Wheezing
- ClinicalTrials.gov ID
- NCT02381158
- Acronym / sponsor ID
- 0000573
- Conditions
- Wheezing
- Keywords
- Wheezing, Children
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Istituto per la Ricerca e l'Innovazione BiomedicaUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 6 Mar 2015 (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.
This is a single-centre, open label study, aiming to evaluate the efficacy of beclomethasone dipropionate applied for 12 weeks with a dose of 400 µg twice a day (total dose 800 µg nebulized), on airway resistance and reactances (measured with Rint and FOT techniques) in children with recurrent wheezing, aged 2-5 years. In addition, clinic score as frequency of symptoms and exacerbations, will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nebulized Beclomethasone dipropionate | Experimental | Drug: Nebulized beclomethasone dipropionateNebulized Beclomethasone dipropionate applied for 12 weeks with a dose of 400 µg twice a day (total dose 800 µg). |
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (13 listed)
- Informed and subscribed consent before any procedure
- Age range : 2 - ≤5 years
- Male and female patients
- Recurrent wheezing affected ( ≥ 4 episodes in the last 12 months)
- PAI positive (at least one primary and two secondary ):
Key exclusion criteria (13 listed)
- story of severe wheeze requiring hospitalization
- treatment with inhaled glucocorticoids during the previous 4 weeks or with oral glucocorticoids in the previous 8 weeks
- structural abnormalities of the lungs (tracheobronchial bronchomalacia, external compressions, etc)
- Persistent infections
- aspiration lung disease (gastroesophageal reflux disease, etc.)
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 |
|---|---|---|
| Nebulized beclomethasone dipropionateAlso: BDPNebulized beclomethasone dipropionate applied for 12 weeks with a dose of 400 µg twice a day (total dose 800 µg) | Drug | Nebulized Beclomethasone dipropionate |
Primary outcome
Lung fuction with Rint and FOT
Time frame: 12 Weeks
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 20 Jan 2017.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nebulized beclomethasone dipropionate in people with Wheezing, run by Istituto per la Ricerca e l'Innovazione Biomedica.
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 13 inclusion and 13 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 20 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Lung fuction with Rint and FOT (time frame: 12 Weeks). 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 20 Jan 2017.