Olfactory DisorderPhase 2SCENTNCT03990766

Smell Changes & Efficacy of Nasal Theophylline

A Phase 2 study testing Theophylline and Saline Nasal in people with Olfactory Disorder and Anosmia, run by Washington University School of Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Olfactory Disorder, Anosmia, Viral Infection
What is being tested?: Theophylline and Saline Nasal
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 27 participants
Where: 1 siteUnited States
Study dates: 15 May 2019to 15 Jan 2021
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subjective or clinically diagnosed olfactory dysfunction of 6 months to 36 months duration after a presumed viral upper respiratory infection
Ability to read, write, and understand English

Who cannot join

Dependence on theophylline for comorbid conditions such as asthma and chronic obstructive pulmonary disease
History of an allergic reaction to theophylline or other methylxanthines
Prior sinonasal or anterior skull base surgery
Nasal polyposis
History of neurodegenerative disease (ie. Alzheimer's dementia, Parkinson's disease, Lewy body dementia, frontotemporal dementia)
Pregnant or breastfeeding mothers
Current use of medications with significant (≥40%) interactions with theophylline, which include cimetidine, ciprofloxacin, disulfiram, enoxacin, fluvoxamine, interferon-alpha, lithium, mexiletine, phenytoin, propafenone, propranolol, tacrine, thiabendazole, ticlopidine, and troleandomycin

Trial locations and contacts

1 site in 1 country.

United States1 site

Washington University in St. Louis
St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: SCENT Trial: Nasal Theophylline Irrigation for Treatment of Post-Viral Olfactory Dysfunction

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.

Conditions: Olfactory Disorder, Anosmia, Viral Infection, Theophylline Causing Adverse Effects in Therapeutic Use, Smell Disorder
Being tested: Theophylline, Saline Nasal
Keywords: Olfactory dysfunction, Anosmia, Hyposmia, Post-viral, Theophylline, Adverse effects, Smell
Medical subject headings: Anosmia, Virus Diseases, Olfaction Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TheophyllineDrug
Theophylline delivered via high-volume, low-pressure nasal saline irrigation
Saline NasalDrug
Lactose delivered via high-volume, low-pressure nasal saline irrigation

Study groups in NCT03990766
Study group	Role	What they receive
Theophylline saline irrigation	Experimental	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. Receives: Drug: Theophylline
Placebo saline irrigation	Placebo comparator	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. Receives: Drug: Saline Nasal

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 6 weeks

Secondary outcomes (3)

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.
Measured: 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.
Measured: 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.
Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 May 201915 Jan 2021

First posted19 Jun 2019
Study start15 May 2019
Primary completion15 Jan 2021
Study completion15 Jan 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Olfactory DisorderStudies of the same condition, open and under way.
More trials run by Washington University School of MedicineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Two randomized arms
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 27 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03990766
Sponsor's protocol ID: 201901107
Acronym: SCENT
Status last verified: Mar 2022
First submitted: 17 Jun 2019
Last updated: 31 Mar 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
RecruitingPhase 2
Enasidenib in IDH2-Mutated Malignant Sinonasal and Skull Base Tumors
Metastatic Chondrosarcoma, Locally Advanced Chondrosarcoma
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
Recruiting
A Clinical Trial to Study the Effects on the Olfaction Capacity of an Individual Undergoing Skull Base Surgeries Using Cautery vs Scalpel .
Olfaction
RecruitingPhase 4
68-Ga DOTATATE PET/MRI in the Diagnosis and Management of Somatostatin Receptor Positive CNS Tumors.
CNS Tumors, Meningioma

All Olfactory Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: SCENT Trial: Nasal Theophylline Irrigation for Treatment of Post-Viral Olfactory Dysfunction
ClinicalTrials.gov ID: NCT03990766
Acronym / sponsor ID: SCENT / 201901107
Conditions: Olfactory Disorder, Anosmia, Viral Infection, Theophylline Causing Adverse Effects in Therapeutic Use, Smell Disorder
Keywords: Olfactory dysfunction, Anosmia, Hyposmia, Post-viral, Theophylline, Adverse effects, Smell
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 27 participants (actual)
Lead sponsor: Washington University School of MedicineUniversity, hospital or other
Study start: 15 May 2019 (actual)
Primary completion: 15 Jan 2021 (actual)
Study completion: 15 Jan 2021 (actual)
First posted: 19 Jun 2019 (actual)
Results: Posted 31 Mar 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: Two randomized arms

Arm	Type	Receives
Theophylline saline irrigation	Experimental	Drug: TheophyllineTheophylline 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.
Placebo saline irrigation	Placebo comparator	Drug: Saline NasalIdentical-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.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Subjective or clinically diagnosed olfactory dysfunction of 6 months to 36 months duration after a presumed viral upper respiratory infection
Ability to read, write, and understand English

Key exclusion criteria (7 listed)

Dependence on theophylline for comorbid conditions such as asthma and chronic obstructive pulmonary disease
History of an allergic reaction to theophylline or other methylxanthines
Prior sinonasal or anterior skull base surgery
Nasal polyposis
History of neurodegenerative disease (ie. Alzheimer's dementia, Parkinson's disease, Lewy body dementia, frontotemporal dementia)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TheophyllineTheophylline delivered via high-volume, low-pressure nasal saline irrigation	Drug	Theophylline saline irrigation
Saline NasalLactose delivered via high-volume, low-pressure nasal saline irrigation	Drug	Placebo saline irrigation

Primary outcome

Number of Patients With Improvement in Global Rating of Smell Change
Time frame: 6 weeks
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.

3 secondary outcomes

University of Pennsylvania Smell Identification Test (UPSIT) Total Score Change
Time frame: 6 weeks
Questionnaire of Olfactory Disorders-Negative Statements (QOD-NS) Score Change
Time frame: 6 weeks
Olfactory Dysfunction Outcomes Ratings (ODOR) Score Change
Time frame: 6 weeks

Results and safety

Results posted to the registry on 31 Mar 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Theophylline	14	12
Placebo	13	10

Primary outcome: Number of Patients With Improvement in Global Rating of Smell Change

Time frame: 6 weeks. Count of participants. Unit: Participants

Measure	Theophylline n = 12	Placebo n = 10
Value	4	3

Theophylline vs Placebo: Risk Difference (RD): 3.3 (95% CI -35.6 to 42.3)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data were collected over 6 weeks of treatment. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Theophylline	0 of 14 (0%)	0 of 14 (0%)	0 of 14
Placebo	0 of 13 (0%)	0 of 13 (0%)	0 of 13

Limitations and caveats (from the sponsor): The diagnosis of PVOD is by patient history and is thus subject to recall bias. In addition, PVOD treatment response may differ according to the causative virus, which is rarely known. The sample size was limited since all non-life saving clinical research and recruitment were halted at our institution at the time due to COVID-19. Lastly, the optimal dosing of theophylline irrigations is yet to be determined.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Olfactory Disorder

RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
RecruitingPhase 2
Enasidenib in IDH2-Mutated Malignant Sinonasal and Skull Base Tumors
Metastatic Chondrosarcoma, Locally Advanced Chondrosarcoma
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
Recruiting
A Clinical Trial to Study the Effects on the Olfaction Capacity of an Individual Undergoing Skull Base Surgeries Using Cautery vs Scalpel .
Olfaction
RecruitingPhase 4
68-Ga DOTATATE PET/MRI in the Diagnosis and Management of Somatostatin Receptor Positive CNS Tumors.
CNS Tumors, Meningioma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Theophylline and Saline Nasal in people with Olfactory Disorder and Anosmia, run by Washington University School of Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Patients With Improvement in Global Rating of Smell Change (time frame: 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03990766.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.