Details

Autor(en) / Beteiligte

• Dejaco, D
• Bocian-Sobkowska, J
• Szymanski, W
• Zacke, G
• Hockner, V
• Riechelmann, H

Titel

Tavipec® in acute rhinosinusitis: a multi-centre, doubleblind, randomized, placebo-controlled, clinical trial

Ist Teil von

• Rhinology, 2019-10, Vol.57 (5), p.367-374

Ort / Verlag

Netherlands

Erscheinungsjahr

2019

Quelle

EZB Free E-Journals

Beschreibungen/Notizen

• This randomized clinical trial was designed to evaluate the efficacy and safety of Tavipec® (Spicae aetheroleum), a phytomedicine obtained by steam distillation of the flowering tops of Lavandula latifolia, as compared to placebo in adult patients suffering from acute viral rhinosinusitis. Patients with acute viral rhinosinusitis were randomly assigned to treatment with 2 capsules Tavipec® 150 mg or placebo thrice daily over a period of 7 days in a double-blind, parallel-group design. No additional treatment was admitted. The efficacy endpoints comprised the improvement of the main rhinosinusitis symptoms as per Major Symptom Score (MSS) and Sino-Nasal Outcome Test (SNOT-22) as well as of quality of life (QoL) by global assessment scale, evaluated at baseline, day 5 and day 8, respectively. 288 patients were enrolled and randomized to treatment. At day 8 the patients in the Tavipec® group had a significantly lower MSS compared to placebo and the impact of rhinosinusitis symptoms on QoL was significantly reduced. A significantly higher proportion of Tavipec® treated patients experienced a change in SNOT-22 score greater than or equal to 10 points at day 5 or day 8. No new safety signals were identified. The treatment with Tavipec® effectively reduced the symptoms of acute rhinosinusitis in adult patients.