Performance and Safety Evaluation of a Hypertonic Seawater Aerosol Therapy Solution in Adults and Children With Upper Respiratory Tract Infection: a Prospective and Multicenter Study
The purpose of this study is to evaluate the tolerance, the performance and safety of this device, 22‰ Hypertonic seawater aerosol therapy solution in unidose container, to treat adult and peadiatric patients with of upper respiratory tract infection such as rhinopharyngitis, rhinitis, acute rhinosinusitis or cold.
The main questions it aims to answer are to assess if the 22‰ Hypertonic seawater solution used as aerosol therapy solution for inhalation:
* improve nasal symptoms relief;
* improve sleep quality;
* improve mucus fluidizing;
* is safe and well tolerated.
The study is none comparative and will assess prospectively the symptomatic and functional benefits, the tolerance and the general safety of the medical device when used as an aerosol therapy solution, measured by change from baseline.
Treatments will be done at home and participants will be required to perform two on sites visits and to complete questionnaires and scales for 7 consecutive days from the treatment starting.
Prospective Multicenter Clinical Investigation to Evaluate the Performance and the Safety of the Mechanical Decongestant Seawater Spray Enriched With Essential Oils From Laboratoires Gilbert (DEMECA)
The purpose of this post-market clinical investigation is to assess the performance and the safety of the mechanical decongestant seawater spray enriched with essential oils from Laboratoires Gilbert. The study will evaluate the results of the spray on the acute rhinitis with nasal obstruction over a 7 days period.
Prospective Multicenter Clinical Investigation Evaluating the Performance and Safety of Gilbert Laboratories' Decongestant Seawater Spray Pocket Valve Enriched With Essential Oils
The purpose of this pre-market clinical investigation is to assess the safety and the performance of decongestant seawater spray pocket valve enriched with essential oils by Gilbert Laboratories. The study will evaluate the results of acute rhinitis associated with nasal obstruction using the decongestant seawaterspray pocket valve enriched with essential oils over a 8 day period.
100 项与 Laboratoires Gilbert SAS 相关的临床结果
0 项与 Laboratoires Gilbert SAS 相关的专利(医药)
2004-08-01·Biological psychiatry1区 · 医学
Is impaired neurogenesis relevant to the affective symptoms of depression?
1区 · 医学
Review
作者: Sapolsky, Robert M
100 项与 Laboratoires Gilbert SAS 相关的药物交易
100 项与 Laboratoires Gilbert SAS 相关的转化医学