Study Comparing Two CE-Marked Throat Sprays for Treating Recent Dry or Wet Cough Caused by Viral Infections in Adults Aged 18 to 65

What this Trial Is About

Researchers are evaluating the real-world safety and tolerability of two CE-marked Class I medical devices formulated as throat sprays, VB-ChSp-D-N CDN and VB-ChSp-W CW, for relieving cough symptoms associated with suspected viral upper respiratory infections. This Phase 4, open-label, randomized study focuses on adults aged 18 to 65 with an acute cough lasting less than three weeks, often due to viral conditions like the common cold or viral pharyngitis. The study aims to ensure both devices meet a pre-defined safety threshold while assessing their impact on cough symptoms and patient quality of life. Participants will be randomly assigned in equal numbers to use either the CDN or CW throat spray for seven days. Treatment begins with an initial dose of four sprays every 30 minutes for two hours on Day 1, followed by maintenance dosing of four sprays every 3 to 4 hours four times daily for Days 2 through 7. Both sprays form a protective film on the throat surface to help lift contaminants and maintain hydration, targeting relief from throat cough. The devices are used as directed by their labeling and are non-systemic. During the study, participants will attend two visits on Day 1 and Day 8 for clinical examination and assessments. They will record daily cough symptoms, adverse events, medication use, and any device issues in an electronic diary. Quality of life related to cough will be measured at the start and end of treatment using a standardized questionnaire. The primary outcome is the incidence of device-related adverse events, while secondary outcomes include changes in cough symptom scores and effects on sleep, daily activities, fatigue, and irritability. The study is conducted at a single center and aims to capture real-world evidence on these medical devices.

Evaluation of Treatments for Dry or Productive Cough