Smell Changes & Efficacy of Nasal Theophylline (SCENT)

The Washington University

Status and phase: Completed; Phase 2

Conditions: Smell Disorder; Anosmia; Theophylline Causing Adverse Effects in Therapeutic Use; Viral Infection; Olfactory Disorder

Treatments: Drug: Theophylline; Drug: Saline Nasal

Study type: Interventional

Funder types: Other

Identifiers

NCT03990766

201901107

Details and patient eligibility

About

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.

Enrollment: 27 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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27 participants in 2 patient groups, including a placebo group

Theophylline saline irrigation

Experimental group

Description:

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.

Treatment:

Drug: Theophylline

Placebo saline irrigation

Placebo Comparator group

Description:

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.

Treatment:

Drug: Saline Nasal