Allergic RhinitisENAPARNCT03963076
Efficacy of Nasal Spray Hypertonic Puressentiel on Symptoms of Allergic Rhinitis
A study testing nasal hypertonic spray: combination of hypertonic sea water and organic rosemary floral water with essential oils (ravintsara, geranium, eucalyptus radiata, niaouli) in people with Allergic Rhinitis, run by Puressentiel at 1 site in France.
Trial summary
Prospective multicentric study. 60 subjects with allergic rhinitis will be enrolled to test the efficacy of nasal hypertonic spray Puressentiel on symptoms of allergic rhinitis and nasal peak flow. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- nasal hypertonic spray: combination of hypertonic sea water and organic rosemary floral water with essential oils (ravintsara, geranium, eucalyptus radiata, niaouli)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 1 May 2019to 31 Oct 2019
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- allergic rhinitis with nasal obstruction
Who cannot join
- pregnant patients
- patients with severe asthma
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Caroline Bonnard
Paris, 75016
Pascal Demoly, 33675034090, pascal.demoly@inserm.fr
About this study
Official title: Evaluation of the Efficiency of Nasal Spray Hypertonic Puressentiel on Symptoms of Patients With Allergic Rhinitis
Prospective multicentric study.
60 subjects with allergic rhinitis will be enrolled to test the efficacy of nasal hypertonic spray Puressentiel on symptoms of allergic rhinitis and nasal peak flow.
Subjects with allergic rhinitis and nasal obstruction will use during 30 days the nasal spray (2 nebulisations /day in each nostril) during 30 days.
Rhinitis symptoms questionnaire and nasal inspiratory peak flow will be evaluated before and after 30 days of exposure.
Read the detailed description
Objective: evaluate the efficiency of a nasal hypertonic spray Puressentiel in subjects with allergic rhinitis and nasal obstruction.
Inclusion criteria: subjects with allergic obstructive rhinitis without treatment or remaining symptomatic despite treatment.
Duration of exposure: 2 nasal sprays per day (morning and evening) during 30 months.
Primary criteria of efficacy: Rhinitis questionnaire.
Secondary criteria: Inspiratory nasal peak flow
- Conditions
- Allergic Rhinitis
- Being tested
- nasal hypertonic spray: combination of hypertonic sea water and organic rosemary floral water with essential oils (ravintsara, geranium, eucalyptus radiata, niaouli)
- 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 hypertonic spray: combination of hypertonic sea water and organic rosemary floral water with essential oils (ravintsara, geranium, eucalyptus radiata, niaouli)Other
One spray of nasal hypertonic spray morning and evening every day during 30 days
| Study group | Role | What they receive |
|---|---|---|
| allergic rhinitis | Experimental | administration of a nasal hypertonic spray twice a day for one month Receives: Other: nasal hypertonic spray: combination of hypertonic sea water and organic rosemary floral water with essential oils (ravintsara, geranium, eucalyptus radiata, niaouli) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rhinitis auto questionnaire symptoms
5 questions quoted from 1 (worse) to 5 (best).
Measured: Measurement at Day 0
Rhinitis auto questionnaire symptoms
5 questions quoted from 1 (worse) to 5 (best).
Measured: Measurement at Day 30
Secondary outcomes (2)
Nasal inspiratory peak flow
Inspiratory nasal peak flow
Measured: Measurement at Day 0 and Day 30
Nasal inspiratory peak flow
Inspiratory nasal peak flow
Measured: Measurement at Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2019
- Study start1 May 2019
- Primary completion30 Sep 2019 (estimated)
- Study completion31 Oct 2019 (estimated)
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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- prospective multicentric study
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Puressentiel
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University Hospital, Montpellier
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03963076
- Sponsor's protocol ID
- Puressentiel
- Acronym
- ENAPAR
- Status last verified
- May 2019
- First submitted
- 18 May 2019
- Last updated
- 24 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficiency of Nasal Spray Hypertonic Puressentiel on Symptoms of Patients With Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT03963076
- Acronym / sponsor ID
- ENAPAR / Puressentiel
- Conditions
- Allergic Rhinitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- PuressentielIndustry (pharma, biotech, devices)
- Collaborators
- University Hospital, Montpellier
- Study start
- 1 May 2019 (actual)
- Primary completion
- 30 Sep 2019 (estimated)
- Study completion
- 31 Oct 2019 (estimated)
- First posted
- 24 May 2019 (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.
Prospective multicentric study.
60 subjects with allergic rhinitis will be enrolled to test the efficacy of nasal hypertonic spray Puressentiel on symptoms of allergic rhinitis and nasal peak flow.
Subjects with allergic rhinitis and nasal obstruction will use during 30 days the nasal spray (2 nebulisations /day in each nostril) during 30 days.
Rhinitis symptoms questionnaire and nasal inspiratory peak flow will be evaluated before and after 30 days of exposure.
Detailed description
Objective: evaluate the efficiency of a nasal hypertonic spray Puressentiel in subjects with allergic rhinitis and nasal obstruction.
Inclusion criteria: subjects with allergic obstructive rhinitis without treatment or remaining symptomatic despite treatment.
Duration of exposure: 2 nasal sprays per day (morning and evening) during 30 months.
Primary criteria of efficacy: Rhinitis questionnaire.
Secondary criteria: Inspiratory nasal peak flow
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- prospective multicentric study
| Arm | Type | Receives |
|---|---|---|
| allergic rhinitis | Experimental | Other: nasal hypertonic spray: combination of hypertonic sea water and organic rosemary floral water with essential oils (ravintsara, geranium, eucalyptus radiata, niaouli)administration of a nasal hypertonic spray twice a day for one month |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- allergic rhinitis with nasal obstruction
Key exclusion criteria (2 listed)
- pregnant patients
- patients with severe asthma
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 hypertonic spray: combination of hypertonic sea water and organic rosemary floral water with essential oils (ravintsara, geranium, eucalyptus radiata, niaouli)One spray of nasal hypertonic spray morning and evening every day during 30 days | Other | allergic rhinitis |
Primary outcome
Rhinitis auto questionnaire symptoms
Time frame: Measurement at Day 0
5 questions quoted from 1 (worse) to 5 (best).
Rhinitis auto questionnaire symptoms
Time frame: Measurement at Day 30
5 questions quoted from 1 (worse) to 5 (best).
2 secondary outcomes
Nasal inspiratory peak flow
Time frame: Measurement at Day 0 and Day 30
Nasal inspiratory peak flow
Time frame: Measurement at Day 30
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2019.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nasal hypertonic spray: combination of hypertonic sea water and organic rosemary floral water with essential oils (ravintsara, geranium, eucalyptus radiata, niaouli) in people with Allergic Rhinitis, run by Puressentiel 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 1 inclusion and 2 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 24 May 2019. 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.
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 pascal Demoly, MD, PhD (33675034090, pascal.demoly@inserm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rhinitis auto questionnaire symptoms (time frame: Measurement at Day 0). The study lists 2 primary outcomes in all. 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 24 May 2019.