Trial Outcomes & Findings for Smell in COVID-19 and Efficacy of Nasal Theophylline (SCENT 3) (NCT NCT05947643)
NCT ID: NCT05947643
Last Updated: 2025-08-20
Results Overview
The Clinical Global Impression-Improvement scale (CGI-I) is a subjective rating scale used to measure changes in a patient's condition over time. It ranges from 1 to 7, where 1 means "Very Much Improved," 2 means "Much Improved," 3 means "Minimally Improved," 4 means "No Change," 5 means "Minimally Worse," 6 means "Much Worse," and 7 means "Very Much Worsened." In this study, participants reporting scores of 1, 2, or 3 on the CGI-I are considered responders to treatment. The primary analysis will compare the proportion of responders between the theophylline and placebo groups assessing both within-subject changes over time and between-group differences. We will measure the response rate defined as the number of participants self-reporting minimal change or larger in the Clinical Global Impression Scale (CGI) scale, divided by the number of participants in each group.The main comparison will be focused on changes at 12-weeks
COMPLETED
PHASE2
77 participants
week 12
2025-08-20
Participant Flow
Per protocol the study plans to enroll 240 patients to account for a 20% dropout rate, aiming to have 200 evaluable participants for the trial. Reported are 77 randomized patients.
Participant milestones
| Measure |
Theophylline
Participants will dissolve the contents of the 400 mg theophylline capsules (experimental) into the sinus rinse bottle containing nasal saline.
theophylline: capsules dissolved in intranasal irrigation
|
Placebo
Participant will dissolve the contents of the identical-appearing lactose capsules (control) into the sinus rinse bottle containing nasal saline.
Placebo: identical-appearing lactose capsules dissolved in intranasal irrigation
|
|---|---|---|
|
Overall Study
STARTED
|
39
|
38
|
|
Overall Study
COMPLETED
|
21
|
27
|
|
Overall Study
NOT COMPLETED
|
18
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Smell in COVID-19 and Efficacy of Nasal Theophylline (SCENT 3)
Baseline characteristics by cohort
| Measure |
Theophylline
n=39 Participants
Participants will dissolve the contents of the 400 mg theophylline capsules (experimental) into the sinus rinse bottle containing nasal saline.
theophylline: capsules dissolved in intranasal irrigation
|
Placebo
n=38 Participants
Participant will dissolve the contents of the identical-appearing lactose capsules (control) into the sinus rinse bottle containing nasal saline.
Placebo: identical-appearing lactose capsules dissolved in intranasal irrigation
|
Total
n=77 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47 years
STANDARD_DEVIATION 14 • n=5 Participants
|
49 years
STANDARD_DEVIATION 13 • n=7 Participants
|
48 years
STANDARD_DEVIATION 13 • n=5 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
18 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian and White
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Parosmia
Yes
|
28 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Parosmia
No
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Phantosmia
Yes
|
17 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Phantosmia
No
|
22 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
The University of Pennsylvania Smell Identification Test
|
25 score on a scale (0-40)
n=5 Participants
|
28 score on a scale (0-40)
n=7 Participants
|
25 score on a scale (0-40)
n=5 Participants
|
|
The Olfactory Dysfunction Outcomes Rating
|
52 score on a scale 0-112
n=5 Participants
|
47 score on a scale 0-112
n=7 Participants
|
49 score on a scale 0-112
n=5 Participants
|
|
Clinical Global Impression of Severity of Smell Loss
Absent
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Clinical Global Impression of Severity of Smell Loss
Poor
|
25 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Clinical Global Impression of Severity of Smell Loss
Fair
|
5 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Clinical Global Impression of Severity of Smell Loss
Good
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Clinical Global Impression of Severity of Smell Loss
Very Good
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Clinical Global Impression of Severity of Smell Loss
Excellent
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: week 12The Clinical Global Impression-Improvement scale (CGI-I) is a subjective rating scale used to measure changes in a patient's condition over time. It ranges from 1 to 7, where 1 means "Very Much Improved," 2 means "Much Improved," 3 means "Minimally Improved," 4 means "No Change," 5 means "Minimally Worse," 6 means "Much Worse," and 7 means "Very Much Worsened." In this study, participants reporting scores of 1, 2, or 3 on the CGI-I are considered responders to treatment. The primary analysis will compare the proportion of responders between the theophylline and placebo groups assessing both within-subject changes over time and between-group differences. We will measure the response rate defined as the number of participants self-reporting minimal change or larger in the Clinical Global Impression Scale (CGI) scale, divided by the number of participants in each group.The main comparison will be focused on changes at 12-weeks
Outcome measures
| Measure |
Theophylline
n=21 Participants
Participants will dissolve the contents of the 400 mg theophylline capsules (experimental) into the sinus rinse bottle containing nasal saline.
theophylline: capsules dissolved in intranasal irrigation
|
Placebo
n=27 Participants
Participant will dissolve the contents of the identical-appearing lactose capsules (control) into the sinus rinse bottle containing nasal saline.
Placebo: identical-appearing lactose capsules dissolved in intranasal irrigation
|
|---|---|---|
|
Clinical Global Impression - Improvement Scale
|
9 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 6 weeks and 12 weekOlfactory Dysfunction Outcomes Rating (ODOR) is a disease-specific questionnaire that assesses for physical, functional, and emotional limitations in participants with olfactory dysfunction of any etiology. The instrument contains 28 total items with each scored on a 5-point Likert scale from 0 to 4. Total score ranges from 0 to 112. Higher scores indicate higher degree of dysfunction and limitation.
Outcome measures
| Measure |
Theophylline
n=21 Participants
Participants will dissolve the contents of the 400 mg theophylline capsules (experimental) into the sinus rinse bottle containing nasal saline.
theophylline: capsules dissolved in intranasal irrigation
|
Placebo
n=27 Participants
Participant will dissolve the contents of the identical-appearing lactose capsules (control) into the sinus rinse bottle containing nasal saline.
Placebo: identical-appearing lactose capsules dissolved in intranasal irrigation
|
|---|---|---|
|
Olfactory Dysfunction Outcomes Rating
6 weeks
|
43.38 score on a scale (0-112)
Interval 34.35 to 52.41
|
45.96 score on a scale (0-112)
Interval 38.21 to 53.72
|
|
Olfactory Dysfunction Outcomes Rating
12 weeks
|
43.94 score on a scale (0-112)
Interval 35.08 to 52.8
|
45.26 score on a scale (0-112)
Interval 37.33 to 53.18
|
SECONDARY outcome
Timeframe: 12 weeksParticipants will be contacted to report the number of irrigations completed over the prior 7 days out of a possible 14. Participants report their compliance with the twice-daily nasal irrigations through self-reported measures in REDCap surveys, including how many rinses they have completed. The measure count represents the self-reported compliance with twice daily irrigations.
Outcome measures
| Measure |
Theophylline
n=29 Participants
Participants will dissolve the contents of the 400 mg theophylline capsules (experimental) into the sinus rinse bottle containing nasal saline.
theophylline: capsules dissolved in intranasal irrigation
|
Placebo
n=32 Participants
Participant will dissolve the contents of the identical-appearing lactose capsules (control) into the sinus rinse bottle containing nasal saline.
Placebo: identical-appearing lactose capsules dissolved in intranasal irrigation
|
|---|---|---|
|
Assessment of Adherence
6 days
|
1 participants
|
1 participants
|
|
Assessment of Adherence
8 days
|
1 participants
|
0 participants
|
|
Assessment of Adherence
10 days
|
1 participants
|
1 participants
|
|
Assessment of Adherence
11 days
|
1 participants
|
0 participants
|
|
Assessment of Adherence
12 days
|
5 participants
|
1 participants
|
|
Assessment of Adherence
13 days
|
2 participants
|
4 participants
|
|
Assessment of Adherence
14 days
|
18 participants
|
25 participants
|
SECONDARY outcome
Timeframe: within first 3 weeksThe assessment of the blind in this study involves contacting participants within the first 3 weeks after starting nasal irrigations and asking them which treatment arm they believe they were assigned to-either "theophylline and nasal saline irrigation" or "nasal saline irrigation alone." The numbers reported represent how many participants correctly guessed an arm in which they were assigned to.
Outcome measures
| Measure |
Theophylline
n=39 Participants
Participants will dissolve the contents of the 400 mg theophylline capsules (experimental) into the sinus rinse bottle containing nasal saline.
theophylline: capsules dissolved in intranasal irrigation
|
Placebo
n=38 Participants
Participant will dissolve the contents of the identical-appearing lactose capsules (control) into the sinus rinse bottle containing nasal saline.
Placebo: identical-appearing lactose capsules dissolved in intranasal irrigation
|
|---|---|---|
|
Assessment of Blind
|
20 Participants
|
26 Participants
|
SECONDARY outcome
Timeframe: up to 12 weeksPatients will be asked to report any adverse effects they experience at any time during the 12-week study period. An adverse event in this study refers to any undesirable or unintended medical occurrence experienced by a participant during the trial, which may or may not be related to the use of intranasal theophylline.
Outcome measures
| Measure |
Theophylline
n=39 Participants
Participants will dissolve the contents of the 400 mg theophylline capsules (experimental) into the sinus rinse bottle containing nasal saline.
theophylline: capsules dissolved in intranasal irrigation
|
Placebo
n=38 Participants
Participant will dissolve the contents of the identical-appearing lactose capsules (control) into the sinus rinse bottle containing nasal saline.
Placebo: identical-appearing lactose capsules dissolved in intranasal irrigation
|
|---|---|---|
|
Adverse Effects
Mild nose bleed
|
1 participants
|
0 participants
|
|
Adverse Effects
Dry nose noted and blood-tinged nasal discharge
|
1 participants
|
0 participants
|
|
Adverse Effects
Small amount of epistaxis and cold during the first week.
|
1 participants
|
0 participants
|
|
Adverse Effects
Upper respiratory infection and sleep disturbing cough
|
1 participants
|
0 participants
|
|
Adverse Effects
Little hard red bumps inside and outside of nose.
|
0 participants
|
1 participants
|
|
Adverse Effects
Migraine
|
0 participants
|
1 participants
|
|
Adverse Effects
Participant developed a sinus infection
|
0 participants
|
3 participants
|
|
Adverse Effects
Patient developed nausea, vomiting, and diarrhea
|
0 participants
|
1 participants
|
|
Adverse Effects
Nasal soreness
|
0 participants
|
1 participants
|
|
Adverse Effects
Urine in blood
|
0 participants
|
1 participants
|
Adverse Events
Theophylline
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Theophylline
n=39 participants at risk
Participants will dissolve the contents of the 400 mg theophylline capsules (experimental) into the sinus rinse bottle containing nasal saline.
theophylline: capsules dissolved in intranasal irrigation
|
Placebo
n=38 participants at risk
Participant will dissolve the contents of the identical-appearing lactose capsules (control) into the sinus rinse bottle containing nasal saline.
Placebo: identical-appearing lactose capsules dissolved in intranasal irrigation
|
|---|---|---|
|
General disorders
mid nose bleed
|
2.6%
1/39 • Number of events 1 • Adverse event data will be collected throughout the entire 12-week study period. Specifically, participants will be asked about adverse events during phone check-ins at weeks 3, 6, 9, and 12. Additionally, participants can report adverse events at any time by contacting the study team via phone or pager, who are available 24/7 during the trial.
Common systemic adverse effects of theophylline include headache, nausea, vomiting, tremors, insomnia, lightheadedness, and restlessness, while serious effects can include tachyarrhythmias, atrial fibrillation, Stevens-Johnson syndrome, intracranial hemorrhage, and seizure. However, intranasal theophylline has shown minimal adverse effects and negligible systemic absorption in prior studies.
|
0.00%
0/38 • Adverse event data will be collected throughout the entire 12-week study period. Specifically, participants will be asked about adverse events during phone check-ins at weeks 3, 6, 9, and 12. Additionally, participants can report adverse events at any time by contacting the study team via phone or pager, who are available 24/7 during the trial.
Common systemic adverse effects of theophylline include headache, nausea, vomiting, tremors, insomnia, lightheadedness, and restlessness, while serious effects can include tachyarrhythmias, atrial fibrillation, Stevens-Johnson syndrome, intracranial hemorrhage, and seizure. However, intranasal theophylline has shown minimal adverse effects and negligible systemic absorption in prior studies.
|
|
General disorders
Dry nose noted and blood tingled nasal discharge
|
2.6%
1/39 • Number of events 1 • Adverse event data will be collected throughout the entire 12-week study period. Specifically, participants will be asked about adverse events during phone check-ins at weeks 3, 6, 9, and 12. Additionally, participants can report adverse events at any time by contacting the study team via phone or pager, who are available 24/7 during the trial.
Common systemic adverse effects of theophylline include headache, nausea, vomiting, tremors, insomnia, lightheadedness, and restlessness, while serious effects can include tachyarrhythmias, atrial fibrillation, Stevens-Johnson syndrome, intracranial hemorrhage, and seizure. However, intranasal theophylline has shown minimal adverse effects and negligible systemic absorption in prior studies.
|
0.00%
0/38 • Adverse event data will be collected throughout the entire 12-week study period. Specifically, participants will be asked about adverse events during phone check-ins at weeks 3, 6, 9, and 12. Additionally, participants can report adverse events at any time by contacting the study team via phone or pager, who are available 24/7 during the trial.
Common systemic adverse effects of theophylline include headache, nausea, vomiting, tremors, insomnia, lightheadedness, and restlessness, while serious effects can include tachyarrhythmias, atrial fibrillation, Stevens-Johnson syndrome, intracranial hemorrhage, and seizure. However, intranasal theophylline has shown minimal adverse effects and negligible systemic absorption in prior studies.
|
|
General disorders
Small amount of epistaxis and cold during the first week
|
2.6%
1/39 • Number of events 1 • Adverse event data will be collected throughout the entire 12-week study period. Specifically, participants will be asked about adverse events during phone check-ins at weeks 3, 6, 9, and 12. Additionally, participants can report adverse events at any time by contacting the study team via phone or pager, who are available 24/7 during the trial.
Common systemic adverse effects of theophylline include headache, nausea, vomiting, tremors, insomnia, lightheadedness, and restlessness, while serious effects can include tachyarrhythmias, atrial fibrillation, Stevens-Johnson syndrome, intracranial hemorrhage, and seizure. However, intranasal theophylline has shown minimal adverse effects and negligible systemic absorption in prior studies.
|
0.00%
0/38 • Adverse event data will be collected throughout the entire 12-week study period. Specifically, participants will be asked about adverse events during phone check-ins at weeks 3, 6, 9, and 12. Additionally, participants can report adverse events at any time by contacting the study team via phone or pager, who are available 24/7 during the trial.
Common systemic adverse effects of theophylline include headache, nausea, vomiting, tremors, insomnia, lightheadedness, and restlessness, while serious effects can include tachyarrhythmias, atrial fibrillation, Stevens-Johnson syndrome, intracranial hemorrhage, and seizure. However, intranasal theophylline has shown minimal adverse effects and negligible systemic absorption in prior studies.
|
|
General disorders
Upper respiratory of infection and sleep disturbing cough
|
2.6%
1/39 • Number of events 1 • Adverse event data will be collected throughout the entire 12-week study period. Specifically, participants will be asked about adverse events during phone check-ins at weeks 3, 6, 9, and 12. Additionally, participants can report adverse events at any time by contacting the study team via phone or pager, who are available 24/7 during the trial.
Common systemic adverse effects of theophylline include headache, nausea, vomiting, tremors, insomnia, lightheadedness, and restlessness, while serious effects can include tachyarrhythmias, atrial fibrillation, Stevens-Johnson syndrome, intracranial hemorrhage, and seizure. However, intranasal theophylline has shown minimal adverse effects and negligible systemic absorption in prior studies.
|
0.00%
0/38 • Adverse event data will be collected throughout the entire 12-week study period. Specifically, participants will be asked about adverse events during phone check-ins at weeks 3, 6, 9, and 12. Additionally, participants can report adverse events at any time by contacting the study team via phone or pager, who are available 24/7 during the trial.
Common systemic adverse effects of theophylline include headache, nausea, vomiting, tremors, insomnia, lightheadedness, and restlessness, while serious effects can include tachyarrhythmias, atrial fibrillation, Stevens-Johnson syndrome, intracranial hemorrhage, and seizure. However, intranasal theophylline has shown minimal adverse effects and negligible systemic absorption in prior studies.
|
|
General disorders
Little hard red bumps inside and outside of nose
|
0.00%
0/39 • Adverse event data will be collected throughout the entire 12-week study period. Specifically, participants will be asked about adverse events during phone check-ins at weeks 3, 6, 9, and 12. Additionally, participants can report adverse events at any time by contacting the study team via phone or pager, who are available 24/7 during the trial.
Common systemic adverse effects of theophylline include headache, nausea, vomiting, tremors, insomnia, lightheadedness, and restlessness, while serious effects can include tachyarrhythmias, atrial fibrillation, Stevens-Johnson syndrome, intracranial hemorrhage, and seizure. However, intranasal theophylline has shown minimal adverse effects and negligible systemic absorption in prior studies.
|
2.6%
1/38 • Number of events 1 • Adverse event data will be collected throughout the entire 12-week study period. Specifically, participants will be asked about adverse events during phone check-ins at weeks 3, 6, 9, and 12. Additionally, participants can report adverse events at any time by contacting the study team via phone or pager, who are available 24/7 during the trial.
Common systemic adverse effects of theophylline include headache, nausea, vomiting, tremors, insomnia, lightheadedness, and restlessness, while serious effects can include tachyarrhythmias, atrial fibrillation, Stevens-Johnson syndrome, intracranial hemorrhage, and seizure. However, intranasal theophylline has shown minimal adverse effects and negligible systemic absorption in prior studies.
|
|
General disorders
Migraine
|
0.00%
0/39 • Adverse event data will be collected throughout the entire 12-week study period. Specifically, participants will be asked about adverse events during phone check-ins at weeks 3, 6, 9, and 12. Additionally, participants can report adverse events at any time by contacting the study team via phone or pager, who are available 24/7 during the trial.
Common systemic adverse effects of theophylline include headache, nausea, vomiting, tremors, insomnia, lightheadedness, and restlessness, while serious effects can include tachyarrhythmias, atrial fibrillation, Stevens-Johnson syndrome, intracranial hemorrhage, and seizure. However, intranasal theophylline has shown minimal adverse effects and negligible systemic absorption in prior studies.
|
2.6%
1/38 • Number of events 1 • Adverse event data will be collected throughout the entire 12-week study period. Specifically, participants will be asked about adverse events during phone check-ins at weeks 3, 6, 9, and 12. Additionally, participants can report adverse events at any time by contacting the study team via phone or pager, who are available 24/7 during the trial.
Common systemic adverse effects of theophylline include headache, nausea, vomiting, tremors, insomnia, lightheadedness, and restlessness, while serious effects can include tachyarrhythmias, atrial fibrillation, Stevens-Johnson syndrome, intracranial hemorrhage, and seizure. However, intranasal theophylline has shown minimal adverse effects and negligible systemic absorption in prior studies.
|
|
General disorders
Participants developed a sinus infection
|
0.00%
0/39 • Adverse event data will be collected throughout the entire 12-week study period. Specifically, participants will be asked about adverse events during phone check-ins at weeks 3, 6, 9, and 12. Additionally, participants can report adverse events at any time by contacting the study team via phone or pager, who are available 24/7 during the trial.
Common systemic adverse effects of theophylline include headache, nausea, vomiting, tremors, insomnia, lightheadedness, and restlessness, while serious effects can include tachyarrhythmias, atrial fibrillation, Stevens-Johnson syndrome, intracranial hemorrhage, and seizure. However, intranasal theophylline has shown minimal adverse effects and negligible systemic absorption in prior studies.
|
7.9%
3/38 • Number of events 3 • Adverse event data will be collected throughout the entire 12-week study period. Specifically, participants will be asked about adverse events during phone check-ins at weeks 3, 6, 9, and 12. Additionally, participants can report adverse events at any time by contacting the study team via phone or pager, who are available 24/7 during the trial.
Common systemic adverse effects of theophylline include headache, nausea, vomiting, tremors, insomnia, lightheadedness, and restlessness, while serious effects can include tachyarrhythmias, atrial fibrillation, Stevens-Johnson syndrome, intracranial hemorrhage, and seizure. However, intranasal theophylline has shown minimal adverse effects and negligible systemic absorption in prior studies.
|
|
General disorders
Patient developed nausea, vomiting and diarrhea
|
0.00%
0/39 • Adverse event data will be collected throughout the entire 12-week study period. Specifically, participants will be asked about adverse events during phone check-ins at weeks 3, 6, 9, and 12. Additionally, participants can report adverse events at any time by contacting the study team via phone or pager, who are available 24/7 during the trial.
Common systemic adverse effects of theophylline include headache, nausea, vomiting, tremors, insomnia, lightheadedness, and restlessness, while serious effects can include tachyarrhythmias, atrial fibrillation, Stevens-Johnson syndrome, intracranial hemorrhage, and seizure. However, intranasal theophylline has shown minimal adverse effects and negligible systemic absorption in prior studies.
|
2.6%
1/38 • Number of events 1 • Adverse event data will be collected throughout the entire 12-week study period. Specifically, participants will be asked about adverse events during phone check-ins at weeks 3, 6, 9, and 12. Additionally, participants can report adverse events at any time by contacting the study team via phone or pager, who are available 24/7 during the trial.
Common systemic adverse effects of theophylline include headache, nausea, vomiting, tremors, insomnia, lightheadedness, and restlessness, while serious effects can include tachyarrhythmias, atrial fibrillation, Stevens-Johnson syndrome, intracranial hemorrhage, and seizure. However, intranasal theophylline has shown minimal adverse effects and negligible systemic absorption in prior studies.
|
|
General disorders
Nasal soreness
|
0.00%
0/39 • Adverse event data will be collected throughout the entire 12-week study period. Specifically, participants will be asked about adverse events during phone check-ins at weeks 3, 6, 9, and 12. Additionally, participants can report adverse events at any time by contacting the study team via phone or pager, who are available 24/7 during the trial.
Common systemic adverse effects of theophylline include headache, nausea, vomiting, tremors, insomnia, lightheadedness, and restlessness, while serious effects can include tachyarrhythmias, atrial fibrillation, Stevens-Johnson syndrome, intracranial hemorrhage, and seizure. However, intranasal theophylline has shown minimal adverse effects and negligible systemic absorption in prior studies.
|
2.6%
1/38 • Number of events 1 • Adverse event data will be collected throughout the entire 12-week study period. Specifically, participants will be asked about adverse events during phone check-ins at weeks 3, 6, 9, and 12. Additionally, participants can report adverse events at any time by contacting the study team via phone or pager, who are available 24/7 during the trial.
Common systemic adverse effects of theophylline include headache, nausea, vomiting, tremors, insomnia, lightheadedness, and restlessness, while serious effects can include tachyarrhythmias, atrial fibrillation, Stevens-Johnson syndrome, intracranial hemorrhage, and seizure. However, intranasal theophylline has shown minimal adverse effects and negligible systemic absorption in prior studies.
|
|
General disorders
Urine in blood
|
0.00%
0/39 • Adverse event data will be collected throughout the entire 12-week study period. Specifically, participants will be asked about adverse events during phone check-ins at weeks 3, 6, 9, and 12. Additionally, participants can report adverse events at any time by contacting the study team via phone or pager, who are available 24/7 during the trial.
Common systemic adverse effects of theophylline include headache, nausea, vomiting, tremors, insomnia, lightheadedness, and restlessness, while serious effects can include tachyarrhythmias, atrial fibrillation, Stevens-Johnson syndrome, intracranial hemorrhage, and seizure. However, intranasal theophylline has shown minimal adverse effects and negligible systemic absorption in prior studies.
|
2.6%
1/38 • Number of events 1 • Adverse event data will be collected throughout the entire 12-week study period. Specifically, participants will be asked about adverse events during phone check-ins at weeks 3, 6, 9, and 12. Additionally, participants can report adverse events at any time by contacting the study team via phone or pager, who are available 24/7 during the trial.
Common systemic adverse effects of theophylline include headache, nausea, vomiting, tremors, insomnia, lightheadedness, and restlessness, while serious effects can include tachyarrhythmias, atrial fibrillation, Stevens-Johnson syndrome, intracranial hemorrhage, and seizure. However, intranasal theophylline has shown minimal adverse effects and negligible systemic absorption in prior studies.
|
Additional Information
Dorina Kallogjeri, Assoc.Professor of Otolaryngology
Washington University, Department of Otolaryngology - Head and Neck Surgery
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place