Treatment of idiopathic rhinitis with kinetic oscillations – a multi-centre randomized controlled study

Abstract

Conclusions: The potential effects of KOS are still uncertain regarding the most effective air pressure to be used as well as the physiological effects on the nasal mucosa. The results of the study do not support a convincing treatment effect by KOS on IR. Objectives: Idiopathic rhinitis (IR) is a common disorder, affecting ∼10–20% of the population. A new method for treating IR, Kinetic Oscillation Stimulation (KOS), has been reported to have beneficial effects on total vasomotor symptom scores (TVRSS). The primary objective with this study was to evaluate if a mean pressure of 65 mbar, pressure amplitude of 100 mbar, and 68 Hz treatment with KOS had a positive effect on total vasomotor symptom scores (TVRSS), as compared with a mean pressure of 65 mbar, pressure amplitude of 4 mbar, and 68 Hz treatment in patients with idiopathic rhinitis. Methods: Two hundred and seven patients were randomized (Full Analysis Set, FAS) in the study, including five visits and lasting for ∼25 weeks. All patients had two treatment episodes, and all patients had at least one treatment, meant as active, with high amplitude pressure for 10 min in each nostril. Group 1 had two such treatments, and Group 2 had one treatment with low amplitude pressure, initially meant as placebo, on one occasion. Because of numerical improvements in these two groups, a new control group, Group 3, was introduced. They had one new control treatment where the balloon was inserted into the nose, without any air inflation and without oscillations. Results: KOS treatment with high amplitude pressure did not have significant beneficial effects as compared to low amplitude pressure on TVRSS. Numerical improvements in TVRSS and SNOT 22 were found when comparing high and low amplitude pressure treatments with uninflated balloon treatment. However, this part of the study was initially single-blinded, and these results were secondary objectives.

Keywords:

• Vasomotor rhinitis
• non-allergic rhinitis
• KOS
• nasal obstruction
• nasal congestion

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Corrigendum

Acknowledgements

Thanks to Kerstin Wiklund, Pharma Consulting Group AB, Uppsala, Sweden, for statistical analysis, and the board of the Swedish Rhinological Research Alliance (SRFA) for their participation in study with planning and analysing the results. This study was financed by Chordate, and grants have been given to SRFA for advice during the study.

Disclosure statement

The authors report no further conflicts of interest.

Funding information

Mats Holmstrlm was paid by Chordate for his consulting work in the study. Petter Olsson is an employee of Novartis Pharma AG. Anders Ehnhage has received grants from MEDA for consulting work.