Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Theophylline saline irrigation | Experimental | 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. |
|
| Placebo saline irrigation | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Theophylline | Drug | Theophylline delivered via high-volume, low-pressure nasal saline irrigation |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University in St. Louis | St Louis | Missouri | 63110 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Theophylline | 12 mg of theophylline dissolved in 240 mL of saline, administered to the bilateral nasal cavities twice a day for 6 weeks |
| FG001 | Placebo | Lactose capsule contents dissolved in 240 mL of saline, administered to the bilateral nasal cavities twice a day for 6 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. Theophylline: Theophylline delivered via high-volume, low-pressure nasal saline irrigation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | 6 weeks |
|
Adverse event data were collected over 6 weeks of treatment
The first 10 participants regardless of intervention underwent theophylline level measurements after 1 week of treatment. If a measurable amount of theophylline was identified, the test would be immediately repeated. If theophylline was detected in the second sample, the plan was to continue measuring in another 10 subjects. In addition, all participants were queried biweekly regarding any adverse effects.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Theophylline | 12 mg of theophylline dissolved in 240 mL of saline, administered to the bilateral nasal cavities twice a day for 6 weeks |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Detectable serum theophylline | Blood and lymphatic system disorders | Systematic Assessment | Detectable serum theophylline level measured by phlebotomy after 1 week of treatment in the first 10 patients |
The diagnosis of PVOD is by patient history and is thus subject to recall bias. In addition, PVOD treatment response may differ according to the causative virus, which is rarely known. The sample size was limited since all non-life saving clinical research and recruitment were halted at our institution at the time due to COVID-19. Lastly, the optimal dosing of theophylline irrigations is yet to be determined.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jake Lee | Washington University School of Medicine | 3143937248 | jakejlee@wustl.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 18, 2019 | Jan 19, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 15, 2021 | Jan 19, 2022 | ICF_001.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000086582 | Anosmia |
| D014777 | Virus Diseases |
| D000857 | Olfaction Disorders |
| ID | Term |
|---|---|
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D013806 | Theophylline |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D014970 | Xanthines |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011688 | Purinones |
Not provided
Not provided
Two randomized arms
Not provided
Not provided
Double-blinded
| Saline Nasal | Drug | Lactose delivered via high-volume, low-pressure nasal saline irrigation |
|
| 6 weeks |
| 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 |
| 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 |
| BG001 | 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. Saline Nasal: Lactose delivered via high-volume, low-pressure nasal saline irrigation |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index | Median | Full Range | kg/m^2 |
|
| Smoking history | Count of Participants | Participants |
|
| Deviated septum | Count of Participants | Participants |
|
| Diabetes mellitus | Count of Participants | Participants |
|
| Obstructive sleep apnea on positive airway pressure | Count of Participants | Participants |
|
| Hypothyroidism | Count of Participants | Participants |
|
| Family history of dementia | Count of Participants | Participants |
|
| Moderate/severe comorbidity (ACE-27 scores 2-3) | Count of Participants | Participants |
|
| Prior oral steroids | Count of Participants | Participants |
|
| Prior nasal steroids | Count of Participants | Participants |
|
| Prior olfactory training | Count of Participants | Participants |
|
| Time from upper respiratory infection to treatment | Median | Full Range | months |
|
Lactose capsule contents dissolved in 240 mL of saline, administered to the bilateral nasal cavities twice a day for 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. | Posted | Median | Full Range | score on a scale | 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. | Posted | Median | Full Range | score on a scale | 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. | Posted | Median | Full Range | score on a scale | 6 weeks |
|
|
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| 0 |
| 14 |
| EG001 | Placebo | Lactose capsule contents dissolved in 240 mL of saline, administered to the bilateral nasal cavities twice a day for 6 weeks | 0 | 13 | 0 | 13 | 0 | 13 |
|
Not provided
Not provided
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007239 | Infections |
| D011687 |
| Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |