Allergic Rhinitis Due to Grass PollenEPPNSNCT04700852
Efficacy of Puressentiel Protective Nasal Spray in Allergic Rhinitis
A study testing Puressentiel protective nasal spray in people with Allergic Rhinitis Due to Grass Pollen and Allergic Inflammation, run by Puressentiel.
Trial summary
This study is a proof o concept aiming to determine the efficacy of Puressentiel nasal protective spray (PNPS) in patients with allergic rhinitis. Cross over study, with a nasal provocative test (NPT) in patients with allergic rhinitis sensitized to grass pollen. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Allergic Rhinitis Due to Grass Pollen, Allergic Inflammation
- What is being tested?
- Puressentiel protective nasal spray
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2021to 30 Sep 2021
- Phase
- Interventional
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with diagnostic of allergic rhinitis sensitized to grass pollen for more than one year with or without associated asthma
Who cannot join
- patients sensitized to a perrianual allergen
- patients with viral infection 4 weeks before inclusion
- patients with severe non controlled asthma
- patients with chronic sinusitis
- pregnancy or breast feeding
- patients with hypersensitivity to essential oil (eucalyptus radie)
- epileptic patient
- patients treated with nasal corticosteroid or anti-histamine
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Efficacy of Puressentiel Protective Nasal Spray on Symptoms and Inflammation in Patients With in Allergic Rhinitis
This study is a proof o concept aiming to determine the efficacy of Puressentiel nasal protective spray (PNPS) in patients with allergic rhinitis.
Cross over study, with a nasal provocative test (NPT) in patients with allergic rhinitis sensitized to grass pollen. A day 0 (first NPT) the following outcomes are recorded: allergic Rhinitis control test (ARCT) and Inspiratory nasal peak flow (INPF) before and 30 min after the NPT. Nasal lavage is performed 30 min after the NPT and 3 cytokines (IL4, IL5 and IL13 are measured by ELISA.
Read more
An other NPT is performed at day 30 and the same outcomes measured.
30 min before NPT 2 nasal sprays of PNPS are administered in each nostril in a randomized manner and cross over, the patient being is own control.
The primary outcomes ins the IL4, IL5 and IL13 concentrations in the nasal lavage. ARCT and INPF are the secondary outcomes.
- Being tested
- Puressentiel protective nasal spray
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Puressentiel protective nasal sprayDevice
provocative nasal test with grass pollen and nasal lavage
| Study group | Role | What they receive |
|---|---|---|
| allergic rhinitis | Experimental | Puressentiel protective nasal spray Receives: Device: Puressentiel protective nasal spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in concentration of IL-13 in the nasal lavage will be assessed
measurement by ELISA
Measured: measurements at day 1 and day 30
Secondary outcomes (4)
Change in concentration of IL-5 in the nasal lavage will be assessed
Measurement by ELISA
Measured: Day1 and Day30
Change in concentration of IL-4 in the nasal lavage will be assessed
Measurement by ELISA
Measured: Day1 and Day 30
Change in Nasal Inspiratory Peak Flow will be assessed
Measurement with a peak flow meter
Measured: Day 1 and Day 30
Change in Allergic Rhinitis Control test (ARCT) will be assessed
5 questions questionnaire score from 0 to 25 (0 worse score), 25 (best score)
Measured: Day 1 and day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2021
- Study start1 Feb 2021 (estimated)
- Primary completion31 Jul 2021 (estimated)
- Study completion30 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic Rhinitis Due to Grass PollenStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Puressentiel
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04700852
- Sponsor's protocol ID
- 2020-A01877-32
- Acronym
- EPPNS
- Status last verified
- Jan 2021
- First submitted
- 10 Nov 2020
- Last updated
- 8 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Puressentiel Protective Nasal Spray on Symptoms and Inflammation in Patients With in Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT04700852
- Acronym / sponsor ID
- EPPNS / 2020-A01877-32
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- PuressentielIndustry (pharma, biotech, devices)
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 1 Feb 2021 (estimated)
- Primary completion
- 31 Jul 2021 (estimated)
- Study completion
- 30 Sep 2021 (estimated)
- First posted
- 8 Jan 2021 (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.
This study is a proof o concept aiming to determine the efficacy of Puressentiel nasal protective spray (PNPS) in patients with allergic rhinitis.
Cross over study, with a nasal provocative test (NPT) in patients with allergic rhinitis sensitized to grass pollen. A day 0 (first NPT) the following outcomes are recorded: allergic Rhinitis control test (ARCT) and Inspiratory nasal peak flow (INPF) before and 30 min after the NPT. Nasal lavage is performed 30 min after the NPT and 3 cytokines (IL4, IL5 and IL13 are measured by ELISA.
An other NPT is performed at day 30 and the same outcomes measured.
30 min before NPT 2 nasal sprays of PNPS are administered in each nostril in a randomized manner and cross over, the patient being is own control.
The primary outcomes ins the IL4, IL5 and IL13 concentrations in the nasal lavage. ARCT and INPF are the secondary outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| allergic rhinitis | Experimental | Device: Puressentiel protective nasal sprayPuressentiel protective nasal spray |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with diagnostic of allergic rhinitis sensitized to grass pollen for more than one year with or without associated asthma
Key exclusion criteria (8 listed)
- patients sensitized to a perrianual allergen
- patients with viral infection 4 weeks before inclusion
- patients with severe non controlled asthma
- patients with chronic sinusitis
- pregnancy or breast feeding
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 |
|---|---|---|
| Puressentiel protective nasal sprayprovocative nasal test with grass pollen and nasal lavage | Device | allergic rhinitis |
Primary outcome
Change in concentration of IL-13 in the nasal lavage will be assessed
Time frame: measurements at day 1 and day 30
measurement by ELISA
4 secondary outcomes
Change in concentration of IL-5 in the nasal lavage will be assessed
Time frame: Day1 and Day30
Change in concentration of IL-4 in the nasal lavage will be assessed
Time frame: Day1 and Day 30
Change in Nasal Inspiratory Peak Flow will be assessed
Time frame: Day 1 and Day 30
Change in Allergic Rhinitis Control test (ARCT) will be assessed
Time frame: Day 1 and day 2
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2021.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Puressentiel protective nasal spray in people with Allergic Rhinitis Due to Grass Pollen and Allergic Inflammation, run by Puressentiel.
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 1 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 8 Jan 2021. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Davide Caimmi, MD (33630061134, davide.caimmi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in concentration of IL-13 in the nasal lavage will be assessed (time frame: measurements at day 1 and day 30). 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 8 Jan 2021.