Back to resultsDirected Topical Drug Delivery for Treatment for PASC Hyposmia
Primary Purpose
Post Acute Sequelae Covid-19 Hyposmia
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Beclomethasone
Placebo
Microsponge
Sponsored by
About this trial
This is an interventional treatment trial for Post Acute Sequelae Covid-19 Hyposmia focused on measuring Covid-19, smell loss, hyposmia
Eligibility Criteria
Inclusion Criteria: Post-COVID hyposmia lasting greater than 3 months following COVID19 by history Male or female, aged 18 years or older Exclusion Criteria: Pregnancy or lactation Known allergic reactions to components of microsponge (including shellfish) or to beclomethasone Known diagnosis of glaucoma Febrile illness within 1 week Treatment with another investigational drug or other intervention within 3 months Active sinonasal disease by nasal exam, i.e. rhinosinusitis, nasal polyps Adults unable to consent Prisoners, employees or subordinates Individuals who are not yet adults (infants, children, teenagers)
Sites / Locations
- Duke University Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Beclomethasone
Placebo
Arm Description
84 mcg of Beclomethasone administered twice in each nostril via a microsponge (Day 1 and Day 14)
Placebo (0.9% sodium chloride) administered twice in each nostril via a microsponge (Day 1 and Day 14)
Outcomes
Primary Outcome Measures
Change in olfactory function as measured by the Smell Identification Test (SIT)
The SIT has a score range of 0 to 40, where a higher score reflects better olfactory function.
Secondary Outcome Measures
Change in olfactory quality of life (QOL) measured by the Questionnaire on Olfactory Disorders (QOD)
The QOD consists of 17 statements which patients report on a scale of 0 to 3. These scores are summed for a total score range of 0 to 51, where a higher score reflects better olfactory-specific QOL.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05970731
Brief Title
Directed Topical Drug Delivery for Treatment for PASC Hyposmia
Official Title
Directed Topical Drug Delivery for Treatment for PASC Hyposmia
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 5, 2023 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
January 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a phase II randomized, double-blinded, placebo-controlled study to evaluate the efficacy of topical intranasal treatment of beclomethasone vs. placebo for improved olfactory function.
Detailed Description
Eligible participants are randomized to receive either Beclomethasone or placebo intranasally via a microsponge twice on day 1 and day 14. Study duration is three months and includes 4 in-person study visits: 2 visits for drug administration at Baseline and Week 2, and 2 follow-up visits at Week 6 and Week 12. Participants will be expected to complete the Smell Identification Test (SIT) and Questionnaire on Olfactory Disorders (QOD) at baseline, Week 6, and Week 12. The investigator hypothesizes that the application of beclomethasone directly in the nasal cavity will result in improved olfactory function.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Acute Sequelae Covid-19 Hyposmia
Keywords
Covid-19, smell loss, hyposmia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Beclomethasone
Arm Type
Active Comparator
Arm Description
84 mcg of Beclomethasone administered twice in each nostril via a microsponge (Day 1 and Day 14)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo (0.9% sodium chloride) administered twice in each nostril via a microsponge (Day 1 and Day 14)
Intervention Type
Drug
Intervention Name(s)
Beclomethasone
Intervention Description
84 mcg of Beclomethasone administered topically on an intranasal microsponge, placed in the olfactory cleft using a nasal endoscope, on day 1 and repeated on day 14.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo (0.9% sodium chloride) administered topically on an intranasal microsponge, placed in the olfactory cleft using a nasal endoscope, on day 1 and repeated on day 14.
Intervention Type
Device
Intervention Name(s)
Microsponge
Intervention Description
Drug delivery using chitosan-based biocompatible microsponge
Primary Outcome Measure Information:
Title
Change in olfactory function as measured by the Smell Identification Test (SIT)
Description
The SIT has a score range of 0 to 40, where a higher score reflects better olfactory function.
Time Frame
Baseline, 6 weeks, 12 weeks
Secondary Outcome Measure Information:
Title
Change in olfactory quality of life (QOL) measured by the Questionnaire on Olfactory Disorders (QOD)
Description
The QOD consists of 17 statements which patients report on a scale of 0 to 3. These scores are summed for a total score range of 0 to 51, where a higher score reflects better olfactory-specific QOL.
Time Frame
Baseline, 6 weeks, 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Post-COVID hyposmia lasting greater than 3 months following COVID19 by history
Male or female, aged 18 years or older
Exclusion Criteria:
Pregnancy or lactation
Known allergic reactions to components of microsponge (including shellfish) or to beclomethasone
Known diagnosis of glaucoma
Febrile illness within 1 week
Treatment with another investigational drug or other intervention within 3 months
Active sinonasal disease by nasal exam, i.e. rhinosinusitis, nasal polyps
Adults unable to consent
Prisoners, employees or subordinates
Individuals who are not yet adults (infants, children, teenagers)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eliza Sorrell
Phone
+1 919 684 6484
Email
eliza.sorrell@duke.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Amy Walker
Phone
+1 919 684 1732
Email
amy.walker1@duke.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bradley Goldstein, MD, PhD
Organizational Affiliation
Duke Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bradley Goldstein, MD, PhD
Phone
919-684-6595
Email
bradley.goldstein@duke.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Directed Topical Drug Delivery for Treatment for PASC Hyposmia
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