A Phase 2 interventional study of Theophylline and Saline Nasal in Olfactory Disorder, Anosmia and Viral Infection, sponsored by Washington University School of Medicine. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-03-31.
Sponsored by Washington University School of Medicine · Phase 2, Interventional, and Treatment
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.
180 studies on the registry are indexed under Anosmia; 45 are open to participants now.
This study's enrollment of 27 is below the median of 60 across 114 interventional studies indexed under Anosmia.
Browse Anosmia studies →Washington University School of Medicine is the lead sponsor of 1,803 studies on the registry; 271 are open to participants now.
Of its 329 completed or terminated interventional studies of FDA-regulated products, 216 (66%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Theophylline
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.
Drug: Saline Nasal
Theophylline delivered via high-volume, low-pressure nasal saline irrigation
Lactose delivered via high-volume, low-pressure nasal saline irrigation
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.
Time frame: 6 weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: 6 weeks
| Milestone | Theophylline | Placebo |
|---|---|---|
| Started | 14 | 13 |
| Completed | 12 | 10 |
| Not completed | 2 | 3 |
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.
| Participants | Theophylline | Placebo |
|---|---|---|
| Number of Patients With Improvement in Global Rating of Smell Change | 4 | 3 |
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.
| score on a scale | Theophylline | Placebo |
|---|---|---|
| University of Pennsylvania Smell Identification Test (UPSIT) Total Score Change | 1 (-4 to 12) | 0 (-8 to 5) |
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.
| score on a scale | Theophylline | Placebo |
|---|---|---|
| Questionnaire of Olfactory Disorders-Negative Statements (QOD-NS) Score Change | -6.5 (-15 to 4) | 1.5 (-4 to 19) |
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.
| score on a scale | Theophylline | Placebo |
|---|---|---|
| Olfactory Dysfunction Outcomes Ratings (ODOR) Score Change | -1.5 (-18 to 6) | -7.5 (-29 to 6) |
Collected over Adverse event data were collected over 6 weeks of treatment. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Theophylline | 0/14 (0%) | 0/14 (0%) | 0/14 (0%) |
| Placebo | 0/13 (0%) | 0/13 (0%) | 0/13 (0%) |
| Event | Theophylline | Placebo |
|---|---|---|
| Detectable serum theophyllineBlood and lymphatic system disorders | 0/5 | 0/5 |
| Age, Continuous(years) | Theophylline Saline Irrigation | Placebo Saline Irrigation | Total |
|---|---|---|---|
| Median | 57.5 (40 to 70) | 59.5 (32 to 67) | 59.0 (32 to 70) |
| Sex: Female, Male(Participants) | Theophylline Saline Irrigation | Placebo Saline Irrigation | Total |
|---|---|---|---|
| Female | 8 | 6 | 14 |
| Male | 4 | 4 | 8 |
| Race (NIH/OMB)(Participants) | Theophylline Saline Irrigation | Placebo Saline Irrigation | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 1 | 2 |
| White | 11 | 9 | 20 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Theophylline Saline Irrigation | Placebo Saline Irrigation | Total |
|---|---|---|---|
| United States | 12 | 10 | 22 |
| Body Mass Index(kg/m^2) | Theophylline Saline Irrigation | Placebo Saline Irrigation | Total |
|---|---|---|---|
| Median | 32.3 (21.6 to 49.5) | 33.0 (22.7 to 45.6) | 33.0 (21.6 to 49.5) |
| Smoking history(Participants) | Theophylline Saline Irrigation | Placebo Saline Irrigation | Total |
|---|---|---|---|
| Count of participants | 0 | 2 | 2 |
| Deviated septum(Participants) | Theophylline Saline Irrigation | Placebo Saline Irrigation | Total |
|---|---|---|---|
| Count of participants | 3 | 2 | 5 |
| Diabetes mellitus(Participants) | Theophylline Saline Irrigation | Placebo Saline Irrigation | Total |
|---|---|---|---|
| Count of participants | 1 | 1 | 2 |
8 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from May 2019 to primary completion in Jan 2021, 20 months.
Results were first posted in Mar 2022, 1 year 2 months after primary completion.
Of 14 phase 2 interventional studies under Anosmia, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 25. This study's 20 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Theophylline
Washington University School of Medicine →