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

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

77 participants

Primary outcome timeframe

week 12

Results posted on

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

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

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 12

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

Outcome measures

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 week

Olfactory 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

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 weeks

Participants 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

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 weeks

The 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

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 weeks

Patients 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

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

Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths

Placebo

Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

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

Phone: 314-362-1077

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place