Tracking Information

First Submitted Date ^ICMJE

June 17, 2019

First Posted Date ^ICMJE

June 19, 2019

Last Update Posted Date

March 19, 2021

Actual Study Start Date ^ICMJE

May 15, 2019

Actual Primary Completion Date

January 15, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Global Rating of Smell Change [ Time Frame: 6 weeks ]

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.

Original Primary Outcome Measures ^ICMJE

Global Rating of Smell Change [ Time Frame: 6 weeks ]

Self-reported change in smell after intervention on a 7-point Likert scale

Change History

Current Secondary Outcome Measures ^ICMJE

University of Pennsylvania Smell Identification Test (UPSIT) Change [ Time Frame: 6 weeks ]
Within- and between-subject changes in UPSIT scores. This test is a validated 40-question forced-choice odor identification test where microencapsulated odorants on a strip are released by scratching. The maximum score is 40, and higher values indicate better outcomes.
Questionnaire of Olfactory Disorders-Negative Statements (QOD-NS) Change [ Time Frame: 6 weeks ]
Within- and between-subject changes in QOD-NS scores, which is a validated 17-item questionnaire about quality of life and impairments related to olfactory dysfunction. The maximum score is 51, and higher values indicate worse quality of life or higher degree of impairment.
Olfactory Dysfunction Outcomes Ratings (ODOR) Change [ Time Frame: 6 weeks ]
Within- and between-subject changes in ODOR. 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. The maximum score is 112, and higher values indicate higher degree of limitations and worse outcomes.

Original Secondary Outcome Measures ^ICMJE

UPSIT Change [ Time Frame: 6 weeks ]
Within- and between-subject changes in University of Pennsylvania Smell Identification Test scores
QOD Change [ Time Frame: 6 weeks ]
Within- and between-subject changes in Questionnaire of Olfactory Disorders scores
QOD-NS Change [ Time Frame: 6 weeks ]
Within- and between-subject changes in Questionnaire of Olfactory Disorders-Negative Statements scores, a validated sub-component of the QOD
ODOR Change [ Time Frame: 6 weeks ]
Within- and between-subject changes in Olfactory Dysfunction Outcomes Ratings

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title ^ICMJE

Smell Changes & Efficacy of Nasal Theophylline

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase ^ICMJE

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Two randomized arms

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:

Double-blinded

Primary Purpose: Treatment

Condition ^ICMJE

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

Intervention ^ICMJE

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

Study Arms ^ICMJE

Experimental: Theophylline saline irrigation
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.

Intervention: Drug: Theophylline
Placebo Comparator: Placebo saline irrigation
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: Drug: Saline Nasal

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Actual Enrollment ^ICMJE

28

Original Estimated Enrollment ^ICMJE

40

Actual Study Completion Date ^ICMJE

January 15, 2021

Actual Primary Completion Date

January 15, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

18 Years to 70 Years (Adult, Older Adult)

Accepts Healthy Volunteers ^ICMJE

No

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT03990766

Other Study ID Numbers ^ICMJE

201901107

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

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

IPD Sharing Statement ^ICMJE

Not Provided

Responsible Party

Washington University School of Medicine

Study Sponsor ^ICMJE

Washington University School of Medicine

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Not Provided

PRS Account

Washington University School of Medicine

Verification Date

March 2021

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

免费获得国外治疗治疗痴呆相关药品，最快 1 个工作日回馈药物信息

Smell Changes & Efficacy of Nasal Theophylline (SCENT)

study details

table view