6/29/23, 11:41 PM SCENT2 Pathway Feedback Search Clinical Topics Home Studies SCENT2 SCENT2 Disease Disease COVID 19 infection Long COVID Trial question What is the role of theophylline saline nasal irrigation in patients with COVID-19-related olfactory dysfunction? Study design Multi-center Double blinded RCT Population Characteristics of study participants 71.0% female N = 51 29.0% male 51 patients (36 female, 15 male) Inclusion criteria: adult patients with chronic olfactory dysfunction following suspected COVID-19 infection Key exclusion criteria: history of olfactory dysfunction prior to COVID-19; nasal polyps; prior sinonasal or anterior skull base surgery; neurodegenerative disease; prior seizures or arrhythmia Interventions N=26 theophylline nasal irrigation (400 mg dissolved in 240 mL isotonic nasal saline lavage BID for 6 weeks) N=25 placebo nasal irrigation (500 mg lactose dissolved in 240 mL isotonic nasal saline lavage daily for 6 weeks) https://web.pathway.md/studies/rec2sPnzp48zGyVIF 1/2 6/29/23, 11:42 PM SCENT2 Pathway Primary outcome Percentage of patients who experienced slightly better improvement in the clinical global impression- improvement scale 59.0 % 59 44.3 % 43 29.5 % 14.8 % No significant difference 0.0 % Theophylline nasal irrigation Placebo nasal irrigation No significant difference in the percentage of patients who experienced slightly better improvement in the clinical global impression-improvement scale (59% vs. 43%; AD 15.6%, 95% CI -13.2 to 44.5) Secondary outcomes No significant difference in improvement in the University of Pennsylvania Smell Identification Test at 6 weeks (AD 3, 95% CI -0.01 to 6.01) No significant difference in quality of life-related to smell loss score reduction at week 6 (0.86 vs. 1.43; AD -0.57, 95% CI -1.14 to 0) No significant difference in parosmia reduction at week 6 (-0.06 vs. 0.06; AD -0.12, 95% CI -0.24 to 0) Safety outcomes No significant difference in adverse events. Conclusion In adult patients with chronic olfactory dysfunction following suspected COVID-19 infection, theophylline nasal irrigation was not superior to placebo nasal irrigation with respect to the percentage of patients who experienced slightly better improvement in the clinical global impression-improvement scale. Reference Shruti Gupta, Jake J Lee, Amber Perrin et al. Efficacy and Safety of Saline Nasal Irrigation Plus Theophylline for Treatment of COVID-19-Related Olfactory Dysfunction: The SCENT2 Phase 2 Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2022 Sep 1;148(9):830-837. Open reference URL https://web.pathway.md/studies/rec2sPnzp48zGyVIF 2/2