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Efficacy of Nasal Spray Hypertonic Puressentiel on Symptoms of Allergic Rhinitis (ENAPAR)

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ClinicalTrials.gov Identifier: NCT03963076
Recruitment Status : Recruiting
First Posted : May 24, 2019
Last Update Posted : May 24, 2019
Sponsor:
Collaborator:
University Hospital, Montpellier
Information provided by (Responsible Party):
Puressentiel

Tracking Information
First Submitted Date  ICMJE May 18, 2019
First Posted Date  ICMJE May 24, 2019
Last Update Posted Date May 24, 2019
Actual Study Start Date  ICMJE May 1, 2019
Estimated Primary Completion Date September 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 23, 2019)
  • 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).
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 23, 2019)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Nasal Spray Hypertonic Puressentiel on Symptoms of Allergic Rhinitis
Official Title  ICMJE Evaluation of the Efficiency of Nasal Spray Hypertonic Puressentiel on Symptoms of Patients With Allergic Rhinitis
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.

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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:
prospective multicentric study
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Allergic Rhinitis
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: allergic rhinitis
administration of a nasal hypertonic spray twice a day for one month
Intervention: Other: nasal hypertonic spray: combination of hypertonic sea water and organic rosemary floral water with essential oils (ravintsara, geranium, eucalyptus radiata, niaouli)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 23, 2019)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 31, 2019
Estimated Primary Completion Date September 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • allergic rhinitis with nasal obstruction

Exclusion Criteria:

  • pregnant patients
  • patients with severe asthma
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: pascal Demoly, MD, PhD 33675034090 pascal.demoly@inserm.fr
Contact: Caroline Bonnard, PhD 33180489432 c.bonnard@puressentiel.com
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03963076
Other Study ID Numbers  ICMJE Puressentiel
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Puressentiel
Study Sponsor  ICMJE Puressentiel
Collaborators  ICMJE University Hospital, Montpellier
Investigators  ICMJE Not Provided
PRS Account Puressentiel
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP