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最高研发阶段批准上市 |
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首次获批日期2004-05-10 |
Efficacy and Safety of Healsea® Children Isotonic Nasal Spray in the Prevention of Upper Respiratory Tract Infections with Nasal Symptoms in Children: a Pre-market Study
Healsea® Children is a class IIa medical device. This is an isotonic seawater-based nasal spray supplemented with a natural Symbiofilm™ extract (0.02%) isolated from marine bacteria. Healsea® Children is indicated in children above 6 years to clean and moisten the nose during colds.
Symbiofilm™, which is not a medicinal product is able to protect the nasal mucosa from viruses' entrance by forming a protective barrier on the nasal mucosa.
By targeting the nose as entry points for viruses, we hypothesise that Healsea® Children used regularly during the respiratory virus season may prevent upper respiratory tracts infections such as cold or flu with nasal symptoms.
The main objective of this premarket clinical investigation is thus to assess the efficacy of Healsea® Children to prevent upper respiratory tract infections with nasal symptoms in healthy children during 3 treatment periods of 28 days interspersed by 2 wash-out periods of 10 days when compared to children not taking Healsea® Children.
138 children will be randomised in the study, 64 in the Healsea® Children group and 64 in the non-treated group.
The subjects (or their parents) will be asked to report the upper respiratory tract infections with nasal symptoms and complication they may have during the study to the physician in charge of the study conduct.
Two study visits and 3 telephone calls are scheduled. The subjects will also complete an electronic diary to report nasal symptoms and adverse event other than upper respiratory tracts infections.
Efficacy and Safety of Healsea® Babykids in the Treatment of Acute Infectious Rhinitis Symptoms in Children
The purpose of this post market clinical investigation is to demonstrate that Healsea® Babykids alleviates symptoms of the acute rhinitis phase with better efficacy than isotonic saline solution used as Placebo in children above 2 years.
Efficacy and Safety of Healsea® Hypertonic Nasal Spray 2.7% in the Treatment of Acute Infectious Rhinitis in Adults
Healsea® Rescue* is a CE-marked class I medical device. This is a saline-based nasal spray supplemented with a natural Symbiofilm™ extract (0.04%) isolated from the marine bacteria. Healsea® Rescue* is indicated in adults for the treatment of symptoms of acute respiratory tract infections, rhinitis or rhinosinusitis, and for reduction of the swelling of the nasal mucosa.
The goal of this clinical trial is to demonstrate that hypertonic saline solution and Symbiofilm™ act in a synergistic manner to alleviate symptoms of the acute rhinitis phase resulting in better efficacy than isotonic saline solution without Symbiofilm™ used as Placebo in adults with early symptoms of common cold / acute infectious rhinitis.
100 项与 Lallemand Pharma AG 相关的临床结果
0 项与 Lallemand Pharma AG 相关的专利(医药)
100 项与 Lallemand Pharma AG 相关的药物交易
100 项与 Lallemand Pharma AG 相关的转化医学