Allergic RhinitisPhase 4NCT02646904
Nebulized Beclometasone Dipropionate Improves Nasal Patency in Children With Allergic Rhinitis
A Phase 4 study testing Nasal Beclomethasone Dipropionate and CERCHIO 10 mg/ml OS in people with Allergic Rhinitis, run by Stefania La Grutta, MD at 2 sites in Italy.
Trial summary
The purpose of this study is to examine in children with persistent AR the effect of the topically applied beclomethasone in comparison with cetirizine on nasal patency evaluated by acoustic rhinometry and subjective nasal symptoms. Read more about this study
- Who is it for?
- Ages 6 to 16 years
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- Nasal Beclomethasone Dipropionate and CERCHIO 10 mg/ml OS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 2 sitesItaly
- Study dates
- May 2016to Jul 2017
- 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 6 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children 6-16 years of age with a history of AR in the previous year
- T5SS: ≥5 in the last week before enrollment
Who cannot join
- asthma symptoms
- 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.
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Institute of Biomedicine and Molecular Immunology (IBIM), National Research Council
Palermo, Sicily, 90146
Institute of Biomedicine and Molecular Immunology, IBIM
Palermo, 90146
About this study
The purpose of this study is to examine in children with persistent AR the effect of the topically applied beclomethasone in comparison with cetirizine on nasal patency evaluated by acoustic rhinometry and subjective nasal symptoms.
- Conditions
- Allergic Rhinitis
- Being tested
- Nasal Beclomethasone Dipropionate, CERCHIO 10 mg/ml OS
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal Beclomethasone DipropionateDrug
Also called NBDP
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 OSDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Beclometasone Dipropionate (BDP) | Experimental | Standard dose (400 µg/daily as 100 µg 1 spray nos bid) of Nasal Beclomethasone Dipropionate for 21 days. Receives: Drug: Nasal Beclomethasone Dipropionate |
| CERCHIO 10 mg/ml OS | Active comparator | 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. Receives: Drug: CERCHIO 10 mg/ml OS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nasal patency evaluated by acoustic rhinometry.
The main objective is to assess the increase of nasal patency in children aged 6-16 with perennial allergic rhinitis (PAR), treated with Beclometasone nasal spray 100 µg/die for 21 days.
Measured: 21 days
Secondary outcomes (1)
Efficacy of Beclometasone nasal spray on subjective nasal symptoms
The secondary objective is to measure the impact of Beclometasone nasal spray 100 µg on subjective nasal symptoms, in children aged 6-16 with perennial allergic rhinitis (PAR), assessed by T4SS Questionnaire(Total 4 Symptoms Score).
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2016 (estimated)
- Study startMay 2016
- Primary completionJun 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic RhinitisStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stefania La Grutta, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Stefania La Grutta, MD, Istituto per la Ricerca e l'Innovazione Biomedica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02646904
- Sponsor's protocol ID
- 9-2015
- Status last verified
- Nov 2017
- First submitted
- 18 Dec 2015
- Last updated
- 20 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: The IPD collected will be available on February 2017. The following participant data will be shared: * Nasal patency * Nasal symptom score * Demographic characteristics All IPD will be obtained from statistical analysis on the dedicated database in which all data are stored.
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nebulized Beclometasone Dipropionate Improves Nasal Patency in Children With Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT02646904
- Acronym / sponsor ID
- 9-2015
- Conditions
- Allergic Rhinitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Stefania La Grutta, MDUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 6 Jan 2016 (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.
The purpose of this study is to examine in children with persistent AR the effect of the topically applied beclomethasone in comparison with cetirizine on nasal patency evaluated by acoustic rhinometry and subjective nasal symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Beclometasone Dipropionate (BDP) | Experimental | Drug: Nasal Beclomethasone DipropionateStandard dose (400 µg/daily as 100 µg 1 spray nos bid) of Nasal Beclomethasone Dipropionate for 21 days. |
| CERCHIO 10 mg/ml OS | Active comparator | Drug: CERCHIO 10 mg/ml OSFor 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. |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- children 6-16 years of age with a history of AR in the previous year
- T5SS: ≥5 in the last week before enrollment
Key exclusion criteria (4 listed)
- asthma symptoms
- 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.
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 |
|---|---|---|
| Nasal Beclomethasone DipropionateAlso: NBDPStandard dose (400 µg/daily as 100 µg 1 spray nos bid) of nebulized Beclomethasone Dipropionate nasal spray for 21 days. | Drug | Beclometasone Dipropionate (BDP) |
| CERCHIO 10 mg/ml OSFor 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. | Drug | CERCHIO 10 mg/ml OS |
Primary outcome
Nasal patency evaluated by acoustic rhinometry.
Time frame: 21 days
The main objective is to assess the increase of nasal patency in children aged 6-16 with perennial allergic rhinitis (PAR), treated with Beclometasone nasal spray 100 µg/die for 21 days.
1 secondary outcome
Efficacy of Beclometasone nasal spray on subjective nasal symptoms
Time frame: 21 days
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 Nov 2017.
- Individual participant dataSharing planned: Yes. The IPD collected will be available on February 2017. The following participant data will be shared: * Nasal patency * Nasal symptom score * Demographic characteristics All IPD will be obtained from statistical analysis on the dedicated database in which all data are stored.
Related trials for Allergic Rhinitis
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Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis_MM09-SIT-063.
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RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis. MM09-SIT-063.
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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.
2 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 Nasal Beclomethasone Dipropionate and CERCHIO 10 mg/ml OS in people with Allergic Rhinitis, run by Stefania La Grutta, MD at 2 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 2 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 20 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. 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?
Nasal patency evaluated by acoustic rhinometry. (time frame: 21 days). 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 Nov 2017.