Allergic RhinitisPhase 4RinASolNCT02729012
Effects of Hypertonic Saline Solution (NACL 3%+NAHCO3) on Nasal Inflammation in Children With AR. RinASol- Pilot Study
A Phase 4 study testing hypertonic saline solution (NACL 3%+NAHCO3) and Saline Solution (NACL 0,9%) in people with Allergic Rhinitis, run by Stefania La Grutta, MD at 1 site in Italy.
Trial summary
The main objective of RinASol project is to assess in patients with seasonal Allergic Rhinitis the effect of hypertonic saline solution NACL 3%+NAHCO3 vs the effect of standard saline solution on nasal inflammation by means of nasal cytology. Read more about this study
- Who is it for?
- Ages 6 to 14 years
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- hypertonic saline solution (NACL 3%+NAHCO3) and Saline Solution (NACL 0,9%)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- Oct 2015to Jun 2016
- 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 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Clinical history of Allergic Rhinitis (for at least 1 year)
- 6 years old ≤ children age ≤ 14 years old
- Total Symptom Score 5: >5 in the last 4 days before screening. Exclusion Criteria
- Signs of acute infections of upper and lower respiratory tract.
- Metabolic, immunological, systemic diseases
- Respiratory tract deformity
- Systemic/Topical therapies with antibiotics or corticosteroids in the previous 30 days.
- Active smoker.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Institute of Biomedicine and Molecular Immunology (IBIM), National Research Council
Palermo, Sicily, 90146
About this study
Official title: Effects of Hypertonic Saline Solution (NACL 3%+NAHCO3) on Nasal Inflammation in Children With Allergic Rhinitis. RinASol- Pilot Study (Allergic Rhinitis Solution)
The main objective of RinASol project is to assess in patients with seasonal Allergic Rhinitis the effect of hypertonic saline solution NACL 3%+NAHCO3 vs the effect of standard saline solution on nasal inflammation by means of nasal cytology.
The secondary objective is the symptom score assessment by T5SS Questionnaire (Total Symptom Score 5)
- Conditions
- Allergic Rhinitis
- Being tested
- hypertonic saline solution (NACL 3%+NAHCO3), Saline Solution (NACL 0,9%)
- Keywords
- Children
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hypertonic saline solution (NACL 3%+NAHCO3)Drug
Treatment with nebulized hypertonic saline solution (NACL 3%+NAHCO3)
Saline Solution (NACL 0,9%)Other
Treatment with nebulized Saline Solution (NACL 0,9%)
| Study group | Role | What they receive |
|---|---|---|
| Case | Active comparator | Allergic Rhinitis Children treated with hypertonic saline solution (NACL 3%+NAHCO3) Receives: Drug: hypertonic saline solution (NACL 3%+NAHCO3) |
| Control | Placebo comparator | Allergic Rhinitis Children treated with saline solution (NACL 0,9%) Receives: Other: Saline Solution (NACL 0,9%) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom score assessment
The main objective is to evaluate the effect of hypertonic saline solution NACL 3%+NAHCO3 vs the effect of standard saline solution on the symptom score assessed by T5SS Questionnaire (Total Symptom Score 5)
Measured: 28 days
Secondary outcomes (1)
Nasal cytology pattern
The secondary objective is to evaluate the effect of hypertonic saline solution NACL 3%+NAHCO3 vs the effect of standard saline solution on nasal inflammation, in patients with seasonal Allergic Rhinitis, by means of nasal cytology.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2016 (estimated)
- Study startOct 2015
- Primary completionJun 2016
- Study completionJun 2016
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
- None (open label)
- Enrolment
- 30 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
- Investigators
- Stefania La Grutta, MD, Principal investigator, IBIM,CNR, PALERMO, ITALY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02729012
- Sponsor's protocol ID
- -11/2014
- Acronym
- RinASol
- Status last verified
- Jan 2017
- First submitted
- 4 Mar 2016
- Last updated
- 12 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Hypertonic Saline Solution (NACL 3%+NAHCO3) on Nasal Inflammation in Children With Allergic Rhinitis. RinASol- Pilot Study (Allergic Rhinitis Solution)
- ClinicalTrials.gov ID
- NCT02729012
- Acronym / sponsor ID
- RinASol / -11/2014
- Conditions
- Allergic Rhinitis
- Keywords
- Children
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Stefania La Grutta, MDUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 6 Apr 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 main objective of RinASol project is to assess in patients with seasonal Allergic Rhinitis the effect of hypertonic saline solution NACL 3%+NAHCO3 vs the effect of standard saline solution on nasal inflammation by means of nasal cytology.
The secondary objective is the symptom score assessment by T5SS Questionnaire (Total Symptom Score 5)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case | Active comparator | Drug: hypertonic saline solution (NACL 3%+NAHCO3)Allergic Rhinitis Children treated with hypertonic saline solution (NACL 3%+NAHCO3) |
| Control | Placebo comparator | Other: Saline Solution (NACL 0,9%)Allergic Rhinitis Children treated with saline solution (NACL 0,9%) |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Clinical history of Allergic Rhinitis (for at least 1 year)
- 6 years old ≤ children age ≤ 14 years old
- Total Symptom Score 5: >5 in the last 4 days before screening. Exclusion Criteria
- Signs of acute infections of upper and lower respiratory tract.
- Metabolic, immunological, systemic diseases
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| hypertonic saline solution (NACL 3%+NAHCO3)Treatment with nebulized hypertonic saline solution (NACL 3%+NAHCO3) | Drug | Case |
| Saline Solution (NACL 0,9%)Treatment with nebulized Saline Solution (NACL 0,9%) | Other | Control |
Primary outcome
Symptom score assessment
Time frame: 28 days
The main objective is to evaluate the effect of hypertonic saline solution NACL 3%+NAHCO3 vs the effect of standard saline solution on the symptom score assessed by T5SS Questionnaire (Total Symptom Score 5)
1 secondary outcome
Nasal cytology pattern
Time frame: 28 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 12 Jan 2017.
- Individual participant dataSharing planned: No
Related trials for Allergic Rhinitis
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Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis_MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis. MM09-SIT-063.
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Enrolling by invitationObservational study
Allergy, Asthma, and Atopic Eczema in Finland
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Prevelance of Bronchial Asthma and Allergic Rhinitis Among Children With Nephrotic Syndrom at Sohag University Hospital
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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.
Stefania La Grutta, MD principal investigator
IBIM,CNR, PALERMO, ITALY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing hypertonic saline solution (NACL 3%+NAHCO3) and Saline Solution (NACL 0,9%) in people with Allergic Rhinitis, run by Stefania La Grutta, MD 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?
The sponsor lists 8 inclusion and 0 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 12 Jan 2017. 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. 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?
Symptom score assessment (time frame: 28 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 12 Jan 2017.