Allergic RhinitisPhase 4RHINAL 2NCT06810947
Evaluation of Treatments for Allergic Rhinitis (Rhinal 2)
A Phase 4 study testing ALLERSPRAY-G (device A) and PCNS (device B) in people with Allergic Rhinitis, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
The goal of this clinical study is to perform a post-market clinical follow-up of 2 medical devices (liquid bandage in the form of a spray : ALLERSPRAY G (product A - code AAG), PCNS (product B - code PC) indicated for symptomatic treatment of allergic rhinitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- ALLERSPRAY-G (device A) and PCNS (device B)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteFrance
- Study dates
- 3 Mar 2025to 22 Apr 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- " Score For Allergic Rhinitis " ≥ 8
- Age ≥ 18
- Able to refrain from using any treatment for allergic rhinitis or any other treatment that could interfere with the purpose of the study,
- Effective contraception for women of reproductive age,
- Cooperation and understanding sufficient to comply with the requirements of the study,
- Acceptance to give written consent and inscription to VRB french platform for the duration of the study,
- Affiliation to the French Social Security system,
Who cannot join
- Known hypersensitivity to any of the components of the evaluated products,
- Use of any treatment to treat allergic rhinitis,
- pregnant or breastfeeding women,
- participating in another clinical trial, or being in the exclusion period, or having received a total amount of benefits exceeding EUR 6000 over the 12 months preceding the start of the trial,
- benefiting from a measure of legal protection (guardianship, deprivation of liberty, safeguard of justice),
- having a medical and / or surgical history judged by the investigator or his representative to be incompatible with the test
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Treatments for Allergic Rhinitis
The goal of this clinical study is to perform a post-market clinical follow-up of 2 medical devices (liquid bandage in the form of a spray : ALLERSPRAY G (product A - code AAG), PCNS (product B - code PC) indicated for symptomatic treatment of allergic rhinitis. This follow-up will consist in collecting real-life clinical data to confirm the safety and efficacy of medical devices used in the treatment of allergic rhinitis of adults patients while allowing an assessment of the product's risk/benefit ratio.
The main questions it aims to answer are:
Read more
- Primary objective : Evaluate in real life the tolerance of medical device A and B used in the treatment of allergic rhinitis.
- Secondary objectives : Evaluate the efficacy of medical device A and B on allergic rhinitis and the quality of life using the device A and B.
No comparison group will be constituated because of the type of study (post market follow up) and no comparison between device A and B will be done.
58 participants (29 for medical device A and 29 for medical device B) with allergic rhinitis will be asked to :
- use medical device A or B during 2 weeks (from inclusion visit to end of study visit),
- complete each day at home a diary (recording intensity of 4 nasal symptoms, adverse events, concomitant treatments),
- complete " Quality of life evaluation (sleep, daily activities, fatigue, irritability) " at inclusion visit and end of study visit.
- Conditions
- Allergic Rhinitis
- Being tested
- ALLERSPRAY-G (device A), PCNS (device B)
- Keywords
- post-market, clinical study, follow up, allergic rhinitis
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALLERSPRAY-G (device A)Device
Symptomatic treatment consists of 3 sprays of medical device A in each nostril while breathing in slightly. This process should be repeated 4 times a day for 14 days by patients participating in the study.
PCNS (device B)Device
Symptomatic treatment consists of 3 sprays of medical device B in each nostril while breathing in slightly. This process should be repeated 4 times a day for 14 days by patients participating in the study.
| Study group | Role | What they receive |
|---|---|---|
| Treatment using medical device A | Experimental | Treatment using medical device A (ALLERSPRAY G), it's a topically applied liquid filmogen bandage (in the form of a hypertonic slightly viscous liquid solution) for the treatment of ALLERGIC RHINITIS OF VARIOUS ORIGINS. Receives: Device: ALLERSPRAY-G (device A) |
| Treatment using medical device B | Experimental | Treatment using medical device B (PCNS), it's a topically applied liquid filmogen bandage (in the form of a hypertonic slightly viscous liquid solution) for the treatment of ALLERGIC RHINITIS OF VARIOUS ORIGINS. Receives: Device: PCNS (device B) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Recording of all adverse events on an electronic journal
Measured: From visit 1 (day 1) to the end of treatment at day 14
Secondary outcomes (5)
Total nasal symptom score (TNSS)
4 symptoms (stuffy nose, runny nose, sneezing, itching nose) will be evaluated (from 0 "no embarassement" to 10 "extremely embarrassed") by the patient every day during the treatment period (from day 1 to day 14). the 4 symptoms composed the total nasal symptom score (TNSS). Basal and the mean last 3 days of treatment TNSS score of will be compared.
Measured: basal and twice a day from visit 1 (day 1) to the end of treatment at day 14
Impact of allergic rhinitis on sleep
Evaluation of how much your allergic rhinitis and associated symptoms interfere/impact on sleep (from 0 (not annoying/not at all impact) and 10 (extremely annoying/very impacted) on a visual analog scale
Measured: basal (day 1) and after the study treatment period (day 15)
Impact of allergic rhinitis on daily activities
Evaluation of how much your allergic rhinitis and associated symptoms interfere/impact on daily activities (from 0 (not annoying/not at all impact) and 10 (extremely annoying/very impacted) on a visual analog scale
Measured: basal (day 1) and after the study treatment period (day 15)
Impact of allergic rhinitis on fatigue
Evaluation of how much your allergic rhinitis and associated symptoms interfere/impact on fatigue (from 0 (not annoying/not at all impact) and 10 (extremely annoying/very impacted) on a visual analog scale
Measured: basal (day 1) and after the study treatment period (day 15)
Impact of allergic rhinitis on irritability
Evaluation of how much your allergic rhinitis and associated symptoms interfere/impact on irritability (from 0 (not annoying/not at all impact) and 10 (extremely annoying/very impacted) on a visual analog scale
Measured: basal (day 1) and after the study treatment period (day 15)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2025
- Study start3 Mar 2025
- Primary completion22 Apr 2025
- Study completion22 Apr 2025
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.
- More trials run by University Hospital, Clermont-FerrandThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 indépendants parallel groups (Product A and B) treating a common pathology.
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Vitrobio
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06810947
- Sponsor's protocol ID
- RBHP 2024 PICKERING
- Acronym
- RHINAL 2
- Status last verified
- Dec 2024
- First submitted
- 31 Jan 2025
- Last updated
- 13 Jun 2025
- 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 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Treatments for Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT06810947
- Acronym / sponsor ID
- RHINAL 2 / RBHP 2024 PICKERING
- Conditions
- Allergic Rhinitis
- Keywords
- post-market, clinical study, follow up, allergic rhinitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Vitrobio
- Study start
- 3 Mar 2025 (actual)
- Primary completion
- 22 Apr 2025 (actual)
- Study completion
- 22 Apr 2025 (actual)
- First posted
- 6 Feb 2025 (actual)
- 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 goal of this clinical study is to perform a post-market clinical follow-up of 2 medical devices (liquid bandage in the form of a spray : ALLERSPRAY G (product A - code AAG), PCNS (product B - code PC) indicated for symptomatic treatment of allergic rhinitis. This follow-up will consist in collecting real-life clinical data to confirm the safety and efficacy of medical devices used in the treatment of allergic rhinitis of adults patients while allowing an assessment of the product's risk/benefit ratio.
The main questions it aims to answer are:
- Primary objective : Evaluate in real life the tolerance of medical device A and B used in the treatment of allergic rhinitis.
- Secondary objectives : Evaluate the efficacy of medical device A and B on allergic rhinitis and the quality of life using the device A and B.
No comparison group will be constituated because of the type of study (post market follow up) and no comparison between device A and B will be done.
58 participants (29 for medical device A and 29 for medical device B) with allergic rhinitis will be asked to :
- use medical device A or B during 2 weeks (from inclusion visit to end of study visit),
- complete each day at home a diary (recording intensity of 4 nasal symptoms, adverse events, concomitant treatments),
- complete " Quality of life evaluation (sleep, daily activities, fatigue, irritability) " at inclusion visit and end of study visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 2 indépendants parallel groups (Product A and B) treating a common pathology.
| Arm | Type | Receives |
|---|---|---|
| Treatment using medical device A | Experimental | Device: ALLERSPRAY-G (device A)Treatment using medical device A (ALLERSPRAY G), it's a topically applied liquid filmogen bandage (in the form of a hypertonic slightly viscous liquid solution) for the treatment of ALLERGIC RHINITIS OF VARIOUS ORIGINS. |
| Treatment using medical device B | Experimental | Device: PCNS (device B)Treatment using medical device B (PCNS), it's a topically applied liquid filmogen bandage (in the form of a hypertonic slightly viscous liquid solution) for the treatment of ALLERGIC RHINITIS OF VARIOUS ORIGINS. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- " Score For Allergic Rhinitis " ≥ 8
- Age ≥ 18
- Able to refrain from using any treatment for allergic rhinitis or any other treatment that could interfere with the purpose of the study,
- Effective contraception for women of reproductive age,
- Cooperation and understanding sufficient to comply with the requirements of the study,
Key exclusion criteria (6 listed)
- Known hypersensitivity to any of the components of the evaluated products,
- Use of any treatment to treat allergic rhinitis,
- pregnant or breastfeeding women,
- participating in another clinical trial, or being in the exclusion period, or having received a total amount of benefits exceeding EUR 6000 over the 12 months preceding the start of the trial,
- benefiting from a measure of legal protection (guardianship, deprivation of liberty, safeguard of justice),
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 |
|---|---|---|
| ALLERSPRAY-G (device A)Symptomatic treatment consists of 3 sprays of medical device A in each nostril while breathing in slightly. This process should be repeated 4 times a day for 14 days by patients participating in the study. | Device | Treatment using medical device A |
| PCNS (device B)Symptomatic treatment consists of 3 sprays of medical device B in each nostril while breathing in slightly. This process should be repeated 4 times a day for 14 days by patients participating in the study. | Device | Treatment using medical device B |
Primary outcome
Adverse events
Time frame: From visit 1 (day 1) to the end of treatment at day 14
Recording of all adverse events on an electronic journal
5 secondary outcomes
Total nasal symptom score (TNSS)
Time frame: basal and twice a day from visit 1 (day 1) to the end of treatment at day 14
Impact of allergic rhinitis on sleep
Time frame: basal (day 1) and after the study treatment period (day 15)
Impact of allergic rhinitis on daily activities
Time frame: basal (day 1) and after the study treatment period (day 15)
Impact of allergic rhinitis on fatigue
Time frame: basal (day 1) and after the study treatment period (day 15)
Impact of allergic rhinitis on irritability
Time frame: basal (day 1) and after the study treatment period (day 15)
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 13 Jun 2025.
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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.
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 ALLERSPRAY-G (device A) and PCNS (device B) in people with Allergic Rhinitis, run by University Hospital, Clermont-Ferrand at 1 site in France.
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 7 inclusion and 6 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 13 Jun 2025. 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 France. 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?
Adverse events (time frame: From visit 1 (day 1) to the end of treatment at day 14). 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 13 Jun 2025.