Efficacy of Nasal Spray Hypertonic Puressentiel on Symptoms of Allergic Rhinitis
- Conditions
- Allergic Rhinitis
- Registration Number
- NCT03963076
- Lead Sponsor
- Puressentiel
- 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
- allergic rhinitis with nasal obstruction
- pregnant patients
- patients with severe asthma
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Rhinitis auto questionnaire symptoms Measurement at Day 30 5 questions quoted from 1 (worse) to 5 (best).
- Secondary Outcome Measures
Name Time Method Nasal inspiratory peak flow Measurement at Day 30 Inspiratory nasal peak flow
Trial Locations
- Locations (1)
Caroline Bonnard
🇫🇷Paris, France