Smell in COVID-19 and Efficacy of Nasal Theophylline (SCENT 3) (NCT05947643) | Clinical Trial Compass
CompletedPhase 2
Smell in COVID-19 and Efficacy of Nasal Theophylline (SCENT 3)
United States77 participantsStarted 2022-11-22
Plain-language summary
The purpose of this Phase II trial is to test the effectiveness of intranasal theophylline irrigations for the treatment of COVID-19 related smell dysfunction. The investigators will compare the effect of theophylline nasal rinses versus placebo nasal rinses on smell symptoms. Participants will be asked to rinse their nose with a medication or placebo capsule dissolved in saltwater twice daily for 12 weeks and fill out surveys about smell before, during, and at the end of treatment.
This study will also be used to describe adverse effects related to intranasal theophylline irrigation.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. males and females ages 18 to 75 years
✓. located within or willing to travel to the state of Missouri or Illinois
✓. Olfactory dysfunction that has persisted for \>3 months following suspected COVID-19 infection
✓. Baseline University of Pennsylvania Smell Identification Test (UPSIT) consistent with decreased olfactory function (\<= 34 in women, \<=33 in men). This test is a clinically validated 40-question forced-choice odor identification test where microencapsulated odorants on a strip are released by scratching.70 This will determine that patients have both subjectively and objectively diagnosed OD prior to undergoing treatment.
✓. Ability to read, write, and understand English and have access to email.
Exclusion criteria
✕. History of olfactory dysfunction prior to COVID-19 infection
✕. Any use of concomitant therapies specifically for the treatment of olfactory dysfunction
✕. Use of or participation in previous trials of intranasal theophylline.