SCENT Trial: Nasal Theophylline Irrigation for Treatment of Post-Viral Olfactory Dysfunction
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 27
- Locations
- 1
- Primary Endpoint
- Number of Patients With Improvement in Global Rating of Smell Change
Study Overview
Brief Summary
This study evaluates the efficacy and safety of nasal theophylline irrigation in treating smell loss related to a viral respiratory infection. Half the participants will undergo nasal theophylline irrigation treatment while the other half will undergo placebo nasal irrigation with saline alone. All participants will have their sense of smell tested before and after 6 weeks of treatment. All participants will also be regularly asked about any potential side effects related to treatment. In addition, the first 10 participants will have their blood drawn to measure their theophylline level after 1 week of starting treatment to ensure it is not abnormally elevated.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Double-blinded
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subjective or clinically diagnosed olfactory dysfunction of 6 months to 36 months duration after a presumed viral upper respiratory infection
- •Ability to read, write, and understand English
Exclusion Criteria
- •Dependence on theophylline for comorbid conditions such as asthma and chronic obstructive pulmonary disease
- •History of an allergic reaction to theophylline or other methylxanthines
- •Prior sinonasal or anterior skull base surgery
- •Nasal polyposis
- •History of neurodegenerative disease (ie. Alzheimer's dementia, Parkinson's disease, Lewy body dementia, frontotemporal dementia)
- •Pregnant or breastfeeding mothers
- •Current use of medications with significant (≥40%) interactions with theophylline, which include cimetidine, ciprofloxacin, disulfiram, enoxacin, fluvoxamine, interferon-alpha, lithium, mexiletine, phenytoin, propafenone, propranolol, tacrine, thiabendazole, ticlopidine, and troleandomycin
Arms & Interventions
Theophylline saline irrigation
Theophylline 12 mg capsule contents dissolved into a sinus rinse bottle containing distilled or boiled tap water and USP Grade Sodium Chloride & Sodium Bicarbonate Mixture commercially prepared packets, delivered to the bilateral nasal cavities twice daily.
Intervention: Theophylline (Drug)
Placebo saline irrigation
Identical-appearing lactose monohydrate capsule contents dissolved into a sinus rinse bottle containing distilled or boiled tap water and USP Grade Sodium Chloride & Sodium Bicarbonate Mixture commercially prepared packets, delivered to the bilateral nasal cavities twice daily.
Intervention: Saline Nasal (Drug)
Outcomes
Primary Outcomes
Number of Patients With Improvement in Global Rating of Smell Change
Time Frame: 6 weeks
Self-reported change in smell after intervention on a 7-point Likert scale. Response options with corresponding point values: 7) Much better, 6) Somewhat better, 5) Slightly better, 4) Neither better nor worse, 3) Slightly worse, 2) Somewhat worse, and 1) Much worse. The maximum score is 7, and higher values indicate better outcomes. A score of 4 is considered neutral. Scores of 5 or higher indicated clinical improvement.
Secondary Outcomes
- Questionnaire of Olfactory Disorders-Negative Statements (QOD-NS) Score Change(6 weeks)
- Olfactory Dysfunction Outcomes Ratings (ODOR) Score Change(6 weeks)
- University of Pennsylvania Smell Identification Test (UPSIT) Total Score Change(6 weeks)