NCT03963076

Efficacy of Nasal Spray Hypertonic Puressentiel on Symptoms of Allergic Rhinitis

Evaluation of the Efficiency of Nasal Spray Hypertonic Puressentiel on Symptoms of Patients With Allergic Rhinitis

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Puressentiel · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Conditions

• Allergic Rhinitis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-05-01
• Primary completion: 2019-09-30
• Completion: 2019-10-31
• First posted: 2019-05-24
• Last updated: 2019-05-24

Locations

1 site across 1 country: France