Back to resultsSmell Changes & Efficacy of Nasal Theophylline (SCENT)
Primary Purpose
Olfactory Disorder, Anosmia, Viral Infection
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Theophylline
Saline Nasal
Sponsored by
About this trial
This is an interventional treatment trial for Olfactory Disorder focused on measuring Olfactory dysfunction, Anosmia, Hyposmia, Post-viral, Theophylline, Adverse effects, Smell
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
Sites / Locations
- Washington University in St. Louis
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Theophylline saline irrigation
Placebo saline irrigation
Arm 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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT03990766
First Posted
June 17, 2019
Last Updated
March 7, 2022
Sponsor
Washington University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT03990766
Brief Title
Smell Changes & Efficacy of Nasal Theophylline
Acronym
SCENT
Official Title
SCENT Trial: Nasal Theophylline Irrigation for Treatment of Post-Viral Olfactory Dysfunction
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
May 15, 2019 (Actual)
Primary Completion Date
January 15, 2021 (Actual)
Study Completion Date
January 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Olfactory Disorder, Anosmia, Viral Infection, Theophylline Causing Adverse Effects in Therapeutic Use, Smell Disorder
Keywords
Olfactory dysfunction, Anosmia, Hyposmia, Post-viral, Theophylline, Adverse effects, Smell
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Two randomized arms
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double-blinded
Allocation
Randomized
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Theophylline saline irrigation
Arm Type
Experimental
Arm 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.
Arm Title
Placebo saline irrigation
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Theophylline
Intervention Description
Theophylline delivered via high-volume, low-pressure nasal saline irrigation
Intervention Type
Drug
Intervention Name(s)
Saline Nasal
Intervention Description
Lactose delivered via high-volume, low-pressure nasal saline irrigation
Primary Outcome Measure Information:
Title
Number of Patients With Improvement in Global Rating of Smell Change
Description
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.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
University of Pennsylvania Smell Identification Test (UPSIT) Total Score Change
Description
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.
Time Frame
6 weeks
Title
Questionnaire of Olfactory Disorders-Negative Statements (QOD-NS) Score Change
Description
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.
Time Frame
6 weeks
Title
Olfactory Dysfunction Outcomes Ratings (ODOR) Score Change
Description
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.
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Washington University in St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
12. IPD Sharing Statement
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Smell Changes & Efficacy of Nasal Theophylline
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