TY - JOUR
T1 - Smell Changes and Efficacy of Nasal Theophylline (SCENT) irrigation
T2 - A randomized controlled trial for treatment of post-viral olfactory dysfunction
AU - Lee, Jake J.
AU - Peterson, Andrew M.
AU - Kallogjeri, Dorina
AU - Jiramongkolchai, Pawina
AU - Kukuljan, Sara
AU - Schneider, John S.
AU - Klatt-Cromwell, Cristine N.
AU - Drescher, Andrew J.
AU - Brunworth, Joseph D.
AU - Piccirillo, Jay F.
N1 - Publisher Copyright:
© 2021
PY - 2022/3/1
Y1 - 2022/3/1
N2 - Objective: To evaluate the efficacy and safety of intranasal theophylline saline irrigation on olfactory recovery in patients with post-viral olfactory dysfunction (PVOD). Methods: Between May 2019 and April 2020, we conducted a double-blinded, placebo-controlled randomized clinical trial of adults with 6–36 months of PVOD. Patients were randomized to nasal theophylline saline irrigation or placebo saline irrigation twice a day for 6 weeks. The primary outcome was the Global Rating of Smell Change. Secondary outcomes were changes in the University of Pennsylvania Smell Identification Test (UPSIT) and Questionnaire of Olfactory Disorders-Negative Statements (QOD-NS). Results: Twenty-two patients (n = 12, theophylline; n = 10, placebo) completed the study. Slightly more patients in the theophylline group (33%) reported improved smell compared to the placebo group (30%, difference 3.3%, 95% CI -35.6% to 42.3%). The median differences in pre- and post-treatment UPSIT and QOD-NS change between the two groups were 1 (95% CI -3 to 5) and -10 (95% CI -15 to -4), respectively in favor of theophylline. Three patients receiving theophylline and 2 receiving placebo had clinically meaningful improvements on the UPSIT (difference 5%, 95% CI -30% to 40%). There were no adverse events, and serum theophylline levels were undetectable in 10/10 patients. Conclusions: While safe, there were no clinically meaningful differences in olfactory change between the two groups except for olfaction-related quality of life, which was better with theophylline. The imprecise estimates suggest future trials will need substantially larger sample sizes or treatment modifications, such as increasing the theophylline dose, to observe larger treatment effects.
AB - Objective: To evaluate the efficacy and safety of intranasal theophylline saline irrigation on olfactory recovery in patients with post-viral olfactory dysfunction (PVOD). Methods: Between May 2019 and April 2020, we conducted a double-blinded, placebo-controlled randomized clinical trial of adults with 6–36 months of PVOD. Patients were randomized to nasal theophylline saline irrigation or placebo saline irrigation twice a day for 6 weeks. The primary outcome was the Global Rating of Smell Change. Secondary outcomes were changes in the University of Pennsylvania Smell Identification Test (UPSIT) and Questionnaire of Olfactory Disorders-Negative Statements (QOD-NS). Results: Twenty-two patients (n = 12, theophylline; n = 10, placebo) completed the study. Slightly more patients in the theophylline group (33%) reported improved smell compared to the placebo group (30%, difference 3.3%, 95% CI -35.6% to 42.3%). The median differences in pre- and post-treatment UPSIT and QOD-NS change between the two groups were 1 (95% CI -3 to 5) and -10 (95% CI -15 to -4), respectively in favor of theophylline. Three patients receiving theophylline and 2 receiving placebo had clinically meaningful improvements on the UPSIT (difference 5%, 95% CI -30% to 40%). There were no adverse events, and serum theophylline levels were undetectable in 10/10 patients. Conclusions: While safe, there were no clinically meaningful differences in olfactory change between the two groups except for olfaction-related quality of life, which was better with theophylline. The imprecise estimates suggest future trials will need substantially larger sample sizes or treatment modifications, such as increasing the theophylline dose, to observe larger treatment effects.
KW - Anosmia
KW - Hyposmia
KW - Olfaction
KW - Quality of life
KW - Smell
KW - Theophylline
KW - Therapeutics
KW - Viral
UR - http://www.scopus.com/inward/record.url?scp=85120736832&partnerID=8YFLogxK
U2 - 10.1016/j.amjoto.2021.103299
DO - 10.1016/j.amjoto.2021.103299
M3 - Article
C2 - 34894449
AN - SCOPUS:85120736832
SN - 0196-0709
VL - 43
JO - American Journal of Otolaryngology - Head and Neck Medicine and Surgery
JF - American Journal of Otolaryngology - Head and Neck Medicine and Surgery
IS - 2
M1 - 103299
ER -