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.
Exclusion Criteria:
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.
Documents are hosted by the registry — open the source record to download them.
This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Washington University School of Medicine