NCT05159271

Efficacy and Safety of Azeol Nasal Spray Versus Placebo in the Treatment of Early Symptoms of Common Cold in Adults

Efficacy and Safety of Azeol Nasal Spray Versus Placebo in the Treatment of Early Symptoms of Common Cold in Adults: the EXSPRAY Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 144 (actual)
• Sponsor: Larena SAS · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The main objective is to evaluate the efficacy of Azéol Spray Nasal, taken two times a day, versus placebo on nasal congestion in subject with common cold.

Detailed description

This study is designed as a multicentric, randomized, double-blind, placebo-controlled with two-arm parallel groups clinical trial. 144 subjects presenting with early symptoms of common cold will be recruited for this study, according to the defined inclusion and exclusion criteria. The main objective is to evaluate the efficacy of Azéol Spray Nasal (Bifidobacterium breve LA 708, extract of cypres Cupressus sempervirens L., extract of Leguminosae Glycyrrhiza glabra L., glycerin and mannitol), taken two times a day, versus placebo on nasal congestion in subject with common cold.

Conditions

• Nasal Congestion

Interventions

Type	Name	Description
DEVICE	Azeol spray nasal	Azeol Spray Nasal is a nasal spray intended to reduce the nasal congestion due to rhinitis, rhinosinusitis and colds which is marketed. The ID is conforming to the European Union (EU) legislation and is bearing the CE-mark. The ID is manufactured by PILEJE S.A.S (France).
DEVICE	Placebo nasal spray	with the same characteristics of appearance and packaging as Azéol Spray Nasal without the active ingredients

Timeline

• Start date: 2021-11-22
• Primary completion: 2023-03-24
• Completion: 2023-04-25
• First posted: 2021-12-16
• Last updated: 2023-11-14

Locations

2 sites across 1 country: France