A prospective, controlled study of SNS01 (ectoine nasal spray) compared to BNO-101 (phytotherapeutic dragées) in patients with acute rhinosinusitis

Abstract

Objectives:

In this observational study, data on the efficacy, effects on quality of life and tolerability of the topical formulation SNS01 (Ectoin Rhinitis nasal spray) were compared to those of BNO-101 (Sinupret forte dragées) in patients with acute rhinosinusitis in the ear, nose, and throat (ENT) clinical setting.

Design and methods:

Patients with the diagnosis of acute rhinosinusitis were included in this non-interventional study with a treatment duration of 14–16 days. They received either a herbal phytotherapeutic dragée (control) or an ectoine-based nasal spray (investigational product), each to be taken according to the instructions for use (IFU) and summary of product characteristics (SPC). At each visit, the physician performed a nasal endoscopy, recorded the Sinusitis Symptom Score and checked for adverse events. During the entire treatment period, patients recorded the Sinusitis Symptom Score in patient diaries. In addition, patients receiving the nasal spray filled out a questionnaire to assess the tolerability of the treatment. To investigate effects on quality of life patients were asked to fill out the German version of a sinusitis-specific HRQL (health related quality of life) questionnaire.

Clinical trial registration:

NCT01684540.

Results:

Patient diary entries, the assessment of the Sinusitis Symptom Score and the HRQL questionnaire demonstrated that the ectoine nasal spray was as effective as the phytotherapeutic dragées in treating acute rhinosinusitis. After two weeks of treatment, the assessments of both the patients’ diaries and physicians’ record forms indicated statistically significant improvement (p ≤ 0.001) in the symptom scores of the two groups (57.8% improvement for ectoine and 49.3% improvement for the phytotherapeutic dragées compared to baseline). Also, overall scores of 80 in the sensory questionnaire confirmed the good tolerability of the nasal spray. Correspondingly, HRQL improved significantly over the course of the treatment in both groups.

Conclusion:

SNS01 and BNO-101 demonstrated comparable effects in the treatment of acute rhinosinusitis.

Limitations:

Following German regulations, this trial was set up as an observational ‘non-interventional’ study, which does not allow for a placebo group or randomization of patients. Although the grade of evidence delivered by the study data is thus reduced from Ib to IIa, it does, however, reflect a realistic view of the most common clinical practice.

Keywords::

• Acute rhinosinusitis
• Ectoine
• Efficacy
• Nasal spray
• Nasal symptoms
• Sinupret
• Sinusitis Symptom Score

Transparency

Declaration of funding

This work has been supported by an unrestricted research grant from bitop AG.

Declaration of financial/other relationships

A.E., J.W., K.S.-H., and R.M. are employed at the Institute of Medical Statistics, Informatics and Epidemiology of the University of Cologne, Germany and have made valuable contribution to this article in either writing or reviewing the manuscript.

CMRO peer reviewers may have received honoraria for their review work. The peer reviewers on this manuscript have disclosed that they have no relevant financial relationships.

Acknowledgments

Editorial assistance in preparing the manuscript for publication was provided by Gena Kittel, IMSIE, Faculty of Medicine, University of Cologne, Germany.

Notes

*Ectoin Rhinitis nasal spray is a registered trade name of bitop AG, Witten, Germany

†Sinupret is a registered trade name of Bionorica SE, Neumarkt in der Oberpfalz, Germany