Nebulized Beclometasone Dipropionate Improves Nasal Patency in Children With Allergic Rhinitis
NCT ID: NCT02646904
Last Updated: 2017-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
68 participants
INTERVENTIONAL
2016-05-31
2017-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Beclometasone Dipropionate (BDP)
Standard dose (400 µg/daily as 100 µg 1 spray nos bid) of Nasal Beclomethasone Dipropionate for 21 days.
Nasal Beclomethasone Dipropionate
Standard dose (400 µg/daily as 100 µg 1 spray nos bid) of nebulized Beclomethasone Dipropionate nasal spray for 21 days.
CERCHIO 10 mg/ml OS
For Children \< 12 years old 10 drops die (5 mg die) for 21 days. For Children \> 12 years old 20 drops die (10 mg die) for 21 days.
CERCHIO 10 mg/ml OS
For Children \< 12 years old 10 drops die (5 mg die) for 21 days. For Children \> 12 years old 20 drops die (10 mg die) for 21 days.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Nasal Beclomethasone Dipropionate
Standard dose (400 µg/daily as 100 µg 1 spray nos bid) of nebulized Beclomethasone Dipropionate nasal spray for 21 days.
CERCHIO 10 mg/ml OS
For Children \< 12 years old 10 drops die (5 mg die) for 21 days. For Children \> 12 years old 20 drops die (10 mg die) for 21 days.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* T5SS: ≥5 in the last week before enrollment
Exclusion Criteria
* acute upper respiratory infections
* anatomic nasal defects (ie, septum deviation), or nasal polyps
* use in the past 4 weeks of nasal or oral corticosteroids, nasal or oral decongestants, antihistamines.
6 Years
16 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Stefania La Grutta, MD
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Stefania La Grutta, MD
MD, Senior Researcher, Coordinator of Pediatric Allergy and Asthma Research Group. Institute of Biomedicine and Molecular Immunology, IBIM, National Research Council of Palermo, Italy.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Institute of Biomedicine and Molecular Immunology (IBIM), National Research Council
Palermo, Sicily, Italy
Institute of Biomedicine and Molecular Immunology, IBIM
Palermo, , Italy
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
9-2015
Identifier Type: -
Identifier Source: org_study_id