Last updated: December 12, 2023
Sponsor: Laboratoires Gilbert
Overall Status: Active - Recruiting
Phase
N/A
Condition
Common Cold
Sinus Infections
Allergy
Treatment
Measurement of peak nasal flow.
Clinical Study ID
NCT05494346
DEVALPO
Ages > 12 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Patient ≥ 12 years.
- Patient with acute rhinitis associated with nasal obstruction during infectiousepisodes such as rhinopharyngitis (cold), rhinosinusitis, or during non-infectiousepisodes such as allergic rhinitis.
- a. Informed adult patient who has given written consent prior to any study specificprocedure. b. Informed minor patient who has given assent and whose legal guardianshave given written consent prior to any study-specific procedure.
- Patient able to meet the study requirements for monitoring, spray use, andquestionnaire completion.
- Patient affiliated to a social security scheme.
Exclusion
Exclusion Criteria:
- Pregnant and/or breastfeeding woman
- Hypersensitivity to seawater and/or known allergies to any of the ingredients ofthe spray.
- Diseases causing narrowing of the airways (e.g. asthma, chronic obstructivepulmonary disease (COPD)) and/or respiratory insufficiency.
- Patients with chronic nasal obstruction.
- Patients on local and systemic vasoconstrictors, local and systemic corticosteroidsand antihistamines, non-steroidal anti-inflammatory drugs (NSAIDs), antibiotics andlocal antiseptics.
- Concomitant use of other nasal sprays, essential oils for local nasal use, nasalcreams or gels.
- Patients under guardianship, curatorship or safeguard of justice.
Study Design
Total Participants: 101
Treatment Group(s): 1
Primary Treatment: Measurement of peak nasal flow.
Phase:
Study Start date:
May 31, 2023
Estimated Completion Date:
November 30, 2024
Connect with a study center
Cabinet Médical Caen
Caen, 14000
FranceActive - Recruiting
Cabinet Médical Gainneville
Gainneville, 76700
FranceSite Not Available
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