Multicentre randomised open controlled pilot study on the efficacy of corticosteroids administered by pulsating aerosol-nebulization versus nasal spray for chronic rhinosinusitis without nasal polyps

Background Chronic rhinosinusitis without nasal polyps (CRSsNP) and unsuccessful conservative treatment often requires sinus surgery. Drug delivery to the paranasal sinuses by nasal spray is limited. A potential improvement in particle deposition may be achieved via pulsating airflow.

Methods Prospective, randomised, open-label, controlled, multicentre pilot study to investigate the potential of budesonide nasal spray (BuNS; 400 µg/d) versus budesonide pulsating aerosol-nebulization with PARI SINUS (BuPS; 280 µg/d) to avoid or postpone sinus surgery in patients with CRSsNP (EudraCT-No. 2013-002421-30). Disease-specific health-related quality of life (SNOT-20 GAV), sinusitis-related impairment and rhinorrhea (visual analogue scales) were outcome measures.

Results All patients (10 BuPS, 9 BuNS) experienced significant improved quality of life after the 8-week treatment-course (median: BuPS -8.0/-22.9%; BuNS -7.5/-41.7%) that continued at 12 and 24 weeks in the BuPS-group (-10.0/-28.6%; -11.0/-31.4%), the BuNS-group declined back to baseline. After treatment, reduction of rhinorrhoea was achieved in the BuPS-group (-20.0/-50.0%) with no changes in the BuNS-group (+2.5/+7.1%), sinusitis-related impairment (BuPS -49.5/-62.3%; BuNS -24.0/-48.0%) and the need for sinus surgery (BuPS -66.7%; BuNS -62.5%) was reduced in both groups.

Conclusion Pulsating airflow for aerosolized delivery of budesonide is effective to avoid or postpone sinus surgery for CRSsNP. In comparison to nasal spray a potentially prolonged treatment effect may be achieved.

Poster-PDF A-1423.pdf

PARI GmbH, Starnberg

Publication History

Article published online:
13 May 2021