Smell Changes & Efficacy of Nasal Theophylline

Viral Infection Clinical Trial

— SCENT  

Official title:

SCENT Trial: Nasal Theophylline Irrigation for Treatment of Post-Viral Olfactory Dysfunction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03990766
• Other study ID #: 201901107
• Status: Completed
• Phase: Phase 2
• Start date: May 15, 2019
• Est. completion date: January 15, 2021

Study information

• Verified date: March 2022
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: January 15, 2021
• Est. primary completion date: January 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Anosmia
• Disease
• Olfaction Disorders
• Olfactory Disorder
• Smell Disorder
• Theophylline Causing Adverse Effects in Therapeutic Use
• Viral Infection
• Virus Diseases

Intervention

Drug:
• Theophylline
Theophylline delivered via high-volume, low-pressure nasal saline irrigation
• Saline Nasal
Lactose delivered via high-volume, low-pressure nasal saline irrigation

Locations

Country	Name	City	State
United States	Washington University in St. Louis	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients With Improvement in Global Rating of Smell Change	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.	6 weeks
Secondary	University of Pennsylvania Smell Identification Test (UPSIT) Total Score Change	Within- and between-subject changes in UPSIT total scores measured at baseline and at 6 weeks after therapy. This test is a validated 40-question forced-choice odor identification test where microencapsulated odorants on a strip are released by scratching. Each question corresponds to one point, and there are no subscales. The minimum score is 0 while the maximum score is 40, and higher values indicate better outcomes.	6 weeks
Secondary	Questionnaire of Olfactory Disorders-Negative Statements (QOD-NS) Score Change	Within- and between-subject changes in QOD-NS scores measured at baseline and at 6 weeks after therapy, which is a validated 17-item questionnaire about quality of life and impairments related to olfactory dysfunction. Each question is scored from 0 to 3 points, and there are no subscales. The minimum score is 0 while the maximum score is 51, and higher values indicate worse quality of life or higher degree of impairment.	6 weeks
Secondary	Olfactory Dysfunction Outcomes Ratings (ODOR) Score Change	Within- and between-subject changes measured at baseline and at 6 weeks after therapy. This test is a new disease-specific 28-item questionnaire that assesses for physical, functional, and emotional limitations in patients with olfactory dysfunction of any etiology. Each question is scored from 0 to 4. The minimum score is 0 while the maximum score is 112, and higher values indicate higher degree of limitations and worse outcomes. There are no subscales within the current questionnaire.	6 weeks