NCT02985515: SNIFFED

Steroid Nasal Irrigation for Flavor Evaluation and Detection Study

Completed NA Results posted Last updated 4 November 2022

What this trial tests

NA trial testing Smell training in Olfactory Disorder in 51 participants. Completed in 20 November 2019.

Timeline

28 September 2016

Primary endpoint
20 November 2019

20 November 2019

Quick facts

Lead sponsor	Washington University School of Medicine
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	51
Start date	28 September 2016
Primary completion	20 November 2019
Estimated completion	20 November 2019
Sites	1 location across United States

Drugs / interventions tested

• Smell training

Conditions studied

• Olfactory Disorder — all drugs for Olfactory Disorder →

Sponsor

Washington University School of Medicine

Who can join

Adults 18 to 70, any sex, with Olfactory Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Pre- and Post-intervention Difference in Functional Connectivity Before and After Smell Training. Primary · 12 weeks

Baseline and post-intervention connectivity within and between regions of interest in the olfactory and olfactory related networks using resting state fMRI will be obtained. Resting-state connectivity was analyzed using the CONN toolbox version 18b (https://web.conn-toolbox.org/) and SPM12, version 7487 (Wellcome Trust Centre for Neuroimaging). Functional connectivity values (Fisher z-transformed Pearson correlation coefficients) were compared using a paired, 2-tailed t test and corrected for multiple comparisons. p\<0.05 was considered to be significant.

Group	Value	95% CI
Smell Training	5

Pre- and Post-intervention Difference in Smell Testing Before and After Budesonide Treatment Secondary · 30 days

Objective pre- and post-intervention differences of participant performance on the UPSIT and Sniffin Sticks tests before and after budesonide saline nasal irrigation. University of Pennsylvania Identification Test (UPSIT) consists of 4 odor-impregnated booklets that participants scratch and sniff to identify various odors, and scores account for differences in sex. Hyposmia is defined as a score of 19 to 34 for females and 19 to 33 for males. Anosmia for either sex is defined as a score below 18. Possible scores range from 0 to 40 with higher scores indicating better sense of smell. Sniffin'

UPSIT

Group	Value	95% CI
Budesonide Nasal Irrigation	19.5	5 – 40

TDI

Group	Value	95% CI
Budesonide Nasal Irrigation	17.5	7 – 27.2

Subjective Response to Smell Training Intervention Secondary · 12 weeks

Participants subjective sense of smell following intervention is measured using a visual analogue scale from 0 to 100 with 0 representing no sense of smell and 100 representing best possible sense of smell.

Group	Value	95% CI
Smell Training	23.8	9 – 83.8

Comparison of Olfactory Network in Healthy Controls to Study Participants Secondary · 1 week

Baseline functional connectivity within and between the olfactory and associated networks of healthy controls will be compared to that of study participants prior to smell intervention treatment as measured by rs-fMRI.Resting-state connectivity was analyzed using the CONN toolbox version 18b (https://web.conn-toolbox.org/) and SPM12, version 7487 (Wellcome Trust Centre for Neuroimaging). Functional connectivity values (Fisher z-transformed Pearson correlation coefficients) were compared using a paired, 2-tailed t test and corrected for multiple comparisons . P \< .05 was considered statistical

Group	Value	95% CI
Control Group	13

Pre- and Post-intervention Difference in Smell Testing Before and After Smell Training Secondary · 12 weeks

Objective pre- and post-intervention differences of participant performance on the UPSIT and Sniffin Sticks tests before and after budesonide saline nasal irrigation. University of Pennsylvania Identification Test (UPSIT) consists of 4 odor-impregnated booklets that participants scratch and sniff to identify various odors, and scores account for differences in sex. Hyposmia is defined as a score of 19 to 34 for females and 19 to 33 for males. Anosmia for either sex is defined as a score below 18. Possible scores range from 0 to 40 with higher scores representing better sense of smell. Sniffi

UPSIT

Group	Value	95% CI
Smell Training	19	9 – 40

TDI

Group	Value	95% CI
Smell Training	18.3	7 – 34.5

Pre and Post Difference in QOD-NS After Smell Training Secondary · 12 weeks

The QOD-NS is a validated 17-item questionnaire that pertains to olfactory-specific quality of life domains adversely impacted by olfactory dysfunction and is inversely scored (maximum score of 51), with higher scores reflective of more impaired quality of life.

Group	Value	95% CI
Smell Training	7.4	0 – 17.1

Adverse events — posted to ClinicalTrials.gov

Time frame: Up through 13 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Control Group

Serious: 0/20 (0%)

Deaths: 0/20

Budesonide Nasal Irrigation

Serious: 0/31 (0%)

Deaths: 0/31

Other adverse events (3 terms — click to expand)

Reaction	System	Control Group	Budesonide Nasal Irrigation
Cavernoma	Nervous system disorders	—	—
extra-axial meningiomas	Nervous system disorders	—	—
pleomorphic adenoma	Nervous system disorders	—	—

Data from ClinicalTrials.gov NCT02985515 adverse events section.

Sponsor's own description

The purpose of this research study is to examine the efficacy of a 12-week smell training intervention for participants with olfactory dysfunction following an infection of the upper respiratory tract.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.