Open Access Journal of Clinical Trials (Mar 2022)

Treatment of Oropharyngeal Symptoms: A Prospective, Single-Dose, Placebo-Controlled, Randomized Clinical Trial

  • Kapoor K,
  • Wilhelm D,
  • Neumeister C,
  • Götz MR,
  • Schwantes U,
  • Bleckert G,
  • Gerstenmaier L,
  • Jambrecina A

Journal volume & issue
Vol. Volume 14
pp. 11 – 23

Abstract

Read online

Katharina Kapoor,1 Dorothea Wilhelm,1 Claudia Neumeister,2 Marcus Rudolf Götz,2 Ulrich Schwantes,2 Gabriele Bleckert,3 Lilli Gerstenmaier,4 Alen Jambrecina4 1Clinical Research, Proderm GmbH, Schenefeld/Hamburg, Germany; 2Research and Development, Dr. Pfleger Arzneimittel GmbH, Bamberg, Germany; 3Statistics, Staburo GmbH, München, Germany; 4Clinical Research, CTC North GmbH & Co. KG at the University Medical Center Hamburg-Eppendorf, Hamburg, GermanyCorrespondence: Claudia Neumeister, Dr. Pfleger Arzneimittel GmbH, Dr.-Robert-Pfleger-Str. 12, Bamberg, 96052, Germany, Tel +49 951 6043-161, Fax +49 951 6043-226, Email [email protected]: Acute oropharyngeal symptoms, such as sore throat, difficulty swallowing, hoarseness, tickly throat, and dry mouth, cause great discomfort. Moistening of the impaired mucosa, caused, for example, by the common cold, air-conditioning, heated rooms, and pollen, can be achieved by providing a protective barrier through the local administration of mucoadhesives. This study investigated whether sucking and chewing a medical device (pastille) containing a specific mixture of four different polysaccharides provides instantaneous symptom-relieving effects.Methods: This clinical study enrolled 40 patients with a sore throat (plus at least one additional acute oropharyngeal symptom). A single dose of either the new pastille or a placebo (each n = 20) was administered. The oropharyngeal symptoms, sore throat, difficulty swallowing, hoarseness, tickly throat and dry mouth were monitored on a visual analog scale at baseline and 3, 6, 10, 15, and 30 minutes after beginning sucking and chewing.Results: Of the patients in the test group, 70% showed at least a 10% improvement regarding sore throat intensity over the observation period. Only 25% of the patients in the placebo group reported the same result. Clear improvements in symptom intensity were also found in dry mouth, tickly throat, and difficulty swallowing. For the symptom hoarseness, the effects were less pronounced.Conclusion: Sucking and chewing of the new polysaccharides-containing pastille resulted in instant relieving effects of oropharyngeal symptoms. The effects lasted for the entire period of sucking and beyond.Keywords: oropharyngeal symptoms, sore throat, dry mouth, polysaccharides, pastille, visual analog scale

Keywords