Efficacy of Nasal Spray Hypertonic Puressentiel on Symptoms of Allergic Rhinitis

Overview

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.

Full Title of Study: “Evaluation of the Efficiency of Nasal Spray Hypertonic Puressentiel on Symptoms of Patients With Allergic Rhinitis”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 30, 2019

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

Interventions

  • Other: 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

Arms, Groups and Cohorts

  • Experimental: allergic rhinitis
    • administration of a nasal hypertonic spray twice a day for one month

Clinical Trial Outcome Measures

Primary Measures

  • 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).

Secondary Measures

  • Nasal inspiratory peak flow
    • Time Frame: Measurement at Day 0 and Day 30
    • Inspiratory nasal peak flow
  • Nasal inspiratory peak flow
    • Time Frame: Measurement at Day 30
    • Inspiratory nasal peak flow

Participating in This Clinical Trial

Inclusion Criteria

  • allergic rhinitis with nasal obstruction Exclusion Criteria:

  • pregnant patients – patients with severe asthma

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Puressentiel
  • Collaborator
    • University Hospital, Montpellier
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • pascal Demoly, MD, PhD, 33675034090, pascal.demoly@inserm.fr

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