Phase 2 N=27 Randomized Quadruple-blind Treatment

Smell Changes & Efficacy of Nasal Theophylline

Olfactory Disorder · Anosmia · Viral Infection · Theophylline Causing Adverse Effects in Therapeutic Use · Smell Disorder

Bottom Line

View on ClinicalTrials.gov: NCT03990766 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2022

Primary outcome: Primary: Number of Patients With Improvement in Global Rating of Smell Change — 4; 3 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Theophylline (Drug); Saline Nasal (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Washington University School of Medicine
Primary completion: Jan 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Patients With Improvement in Global Rating of Smell Change	4; 3	—
SECONDARY University of Pennsylvania Smell Identification Test (UPSIT) Total Score Change	1; 0	—
SECONDARY Questionnaire of Olfactory Disorders-Negative Statements (QOD-NS) Score Change	-6.5; 1.5	—
SECONDARY Olfactory Dysfunction Outcomes Ratings (ODOR) Score Change	-1.5; -7.5	—

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.

Eligibility Criteria

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

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Data sourced from ClinicalTrials.gov (NCT03990766). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.