Smell Changes & Efficacy of Nasal Theophylline

• Status: Completed
• Trial end date: 2021-01-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Washington University School of Medicine
• Treatments: Theophylline

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