Efficacy of Nasal Spray Hypertonic Puressentiel on Symptoms of Allergic Rhinitis
ENAPAR
Evaluation of the Efficiency of Nasal Spray Hypertonic Puressentiel on Symptoms of Patients With Allergic Rhinitis
1 other identifier
interventional
60
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2019
CompletedFirst Submitted
Initial submission to the registry
May 18, 2019
CompletedFirst Posted
Study publicly available on registry
May 24, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2019
CompletedMay 24, 2019
May 1, 2019
5 months
May 18, 2019
May 23, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
Rhinitis auto questionnaire symptoms
5 questions quoted from 1 (worse) to 5 (best).
Measurement at Day 0
Rhinitis auto questionnaire symptoms
5 questions quoted from 1 (worse) to 5 (best).
Measurement at Day 30
Secondary Outcomes (2)
Nasal inspiratory peak flow
Measurement at Day 0 and Day 30
Nasal inspiratory peak flow
Measurement at Day 30
Study Arms (1)
allergic rhinitis
EXPERIMENTALadministration of a nasal hypertonic spray twice a day for one month
Interventions
One spray of nasal hypertonic spray morning and evening every day during 30 days
Eligibility Criteria
You may qualify if:
- allergic rhinitis with nasal obstruction
You may not qualify if:
- pregnant patients
- patients with severe asthma
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Puressentiellead
- University Hospital, Montpelliercollaborator
Study Sites (1)
Caroline Bonnard
Paris, 75016, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 18, 2019
First Posted
May 24, 2019
Study Start
May 1, 2019
Primary Completion
September 30, 2019
Study Completion
October 31, 2019
Last Updated
May 24, 2019
Record last verified: 2019-05
Data Sharing
- IPD Sharing
- Will not share