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NCT03990766 · ClinicalTrials.gov registry record · Phase 2
Smell Changes & Efficacy of Nasal Theophylline
A Phase 2 study of Viral Infection and Anosmia, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- Phase 2
- Development phase
- 27
- Enrollment target
- 1
- Study location
NCT03990766: Completed Phase 2 study of Viral Infection and Anosmia, sponsored by Washington University School of Medicine.
NCT03990766 is a Phase 2 study of Viral Infection and Anosmia that has completed, run by Washington University School of Medicine. The registered enrollment target is 27 participants, below the 227-participant average among 11 other Viral Infection trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03990766, a Phase 2 study of Viral Infection and Anosmia, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 27 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Theophylline
- DRUG Saline Nasal
Study Locations (1)
Missouri
- Washington University in St. Louis - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2019-05-15 |
| Est. Completion | 2021-01-15 |
| Phase | Phase 2 |
What the finished NCT03990766 record still lists
NCT03990766 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 227-participant average among 11 other Viral Infection trials with a reported enrollment target (88% lower).
The record links to 5 conditions, with Viral Infection appearing as the primary indexed condition, and to 2 interventions - of which Theophylline is the first listed.
NCT03990766 reports a single indexed study location in Missouri.
Frequently Asked Questions
What is clinical trial NCT03990766 about?
NCT03990766 is a clinical study titled "Smell Changes & Efficacy of Nasal Theophylline". 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 ...
What is the current status of trial NCT03990766?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 27 participants. The study started on 2019-05-15. Estimated completion is 2021-01-15.
What conditions does trial NCT03990766 study?
This clinical trial studies the following conditions: Viral Infection, Anosmia, Olfactory Disorder, Theophylline Causing Adverse Effects in Therapeutic Use, Smell Disorder.
What interventions are being tested in trial NCT03990766?
The interventions under investigation include: Theophylline (DRUG), Saline Nasal (DRUG).
Who is sponsoring clinical trial NCT03990766?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03990766 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03990766's enrollment target sits among peer trials
27 12th of 11 the lowest of 11 other Viral Infection trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Viral Infection trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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