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
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.
|Condition or disease||Intervention/treatment||Phase|
|Allergic Rhinitis||Other: nasal hypertonic spray: combination of hypertonic sea water and organic rosemary floral water with essential oils (ravintsara, geranium, eucalyptus radiata, niaouli)||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||prospective multicentric study|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of the Efficiency of Nasal Spray Hypertonic Puressentiel on Symptoms of Patients With Allergic Rhinitis|
|Actual Study Start Date :||May 1, 2019|
|Estimated Primary Completion Date :||September 30, 2019|
|Estimated Study Completion Date :||October 31, 2019|
Experimental: allergic rhinitis
administration of a nasal hypertonic spray twice a day for one month
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
- 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).
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03963076
|Contact: pascal Demoly, MD, PhDfirstname.lastname@example.org|
|Contact: Caroline Bonnard, PhDemail@example.com|
|Paris, France, 75016|
|Contact: Pascal Demoly 33675034090 firstname.lastname@example.org|