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出境医 / 临床实验 / Smell Changes & Efficacy of Nasal Theophylline (SCENT)
Smell Changes & Efficacy of Nasal Theophylline (SCENT)
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Olfactory Disorder Anosmia Viral Infection Theophylline Causing Adverse Effects in Therapeutic Use Smell Disorder | Drug: Theophylline Drug: Saline Nasal | Phase 2 |
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 28 participants |
| 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 |
| Official Title: | SCENT Trial: Nasal Theophylline Irrigation for Treatment of Post-Viral Olfactory Dysfunction |
| Actual Study Start Date : | May 15, 2019 |
| Actual Primary Completion Date : | January 15, 2021 |
| Actual Study Completion Date : | January 15, 2021 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
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.
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Drug: Theophylline
Theophylline delivered via high-volume, low-pressure nasal saline irrigation
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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.
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Drug: Saline Nasal
Lactose delivered via high-volume, low-pressure nasal saline irrigation
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Outcome Measures
Primary Outcome Measures :
- 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.
Secondary Outcome Measures :
- 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.
Eligibility Criteria
| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Locations
| United States, Missouri | |
| Washington University in St. Louis | |
| Saint Louis, Missouri, United States, 63110 | |
Sponsors and Collaborators
Washington University School of Medicine
| 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.
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| 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
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| Change History | |||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| 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
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| 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:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| 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 |
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| 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 | ||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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