Post Acute Sequelae Covid-19 HyposmiaPhase 2NCT05970731
Directed Topical Drug Delivery for Treatment for PASC Hyposmia
A Phase 2 study testing Beclomethasone and Microsponge in people with Post Acute Sequelae Covid-19 Hyposmia, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Acute Sequelae Covid-19 Hyposmia
- What is being tested?
- Beclomethasone and Microsponge
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Sep 2023to 7 Oct 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Post-COVID hyposmia lasting greater than 3 months following COVID19 by history
- Male or female, aged 18 years or older
Who cannot join
- 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
Show all 9Show fewer
- Adults unable to consent
- Prisoners, employees or subordinates
- Individuals who are not yet adults (infants, children, teenagers)
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
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.
Read the 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 18. Participants will be expected to complete the Smell Identification Test (SIT) and Questionnaire on Olfactory Disorders (QOD) at baseline, Week 6, and Week 18. The investigator hypothesizes that the application of beclomethasone directly in the nasal cavity will result in improved olfactory function.
- Conditions
- Post Acute Sequelae Covid-19 Hyposmia
- Being tested
- Beclomethasone, Placebo, Microsponge
- Keywords
- Covid-19, smell loss, hyposmia
- Medical subject headings
- COVID-19, Anosmia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BeclomethasoneDrug
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.
PlaceboOther
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.
MicrospongeDevice
Drug delivery using chitosan-based biocompatible microsponge
| Study group | Role | What they receive |
|---|---|---|
| Beclomethasone | Active comparator | 84 mcg of Beclomethasone administered twice in each nostril via a microsponge (Day 1 and Day 14) Receives: Drug: Beclomethasone; Device: Microsponge |
| Placebo | Placebo comparator | Placebo (0.9% sodium chloride) administered twice in each nostril via a microsponge (Day 1 and Day 14) Receives: Other: Placebo; Device: Microsponge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Achieving MCID (Minimal Clinically Important Difference) on the Smell Identification Test (SIT)
The SIT has a score range of 0 to 40, where a higher score reflects better olfactory function. MCID is defined at a 4 point increase.
Measured: Baseline, 1 month, 3 months
Secondary outcomes (1)
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. The change from baseline to 3 months is reported.
Measured: Baseline, 1 month, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start5 Sep 2023
- Primary completion7 Oct 2024
- Study completion7 Oct 2024
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 Post Acute Sequelae Covid-19 HyposmiaStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bradley Goldstein, MD, PhD, Principal investigator, Duke Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05970731
- Sponsor's protocol ID
- Pro00113299
- Status last verified
- Feb 2026
- First submitted
- 24 Jul 2023
- Last updated
- 19 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Directed Topical Drug Delivery for Treatment for PASC Hyposmia
- ClinicalTrials.gov ID
- NCT05970731
- Acronym / sponsor ID
- Pro00113299
- Conditions
- Post Acute Sequelae Covid-19 Hyposmia
- Keywords
- Covid-19, smell loss, hyposmia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 5 Sep 2023 (actual)
- Primary completion
- 7 Oct 2024 (actual)
- Study completion
- 7 Oct 2024 (actual)
- First posted
- 1 Aug 2023 (actual)
- Results
- Posted 19 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 18. Participants will be expected to complete the Smell Identification Test (SIT) and Questionnaire on Olfactory Disorders (QOD) at baseline, Week 6, and Week 18. The investigator hypothesizes that the application of beclomethasone directly in the nasal cavity will result in improved olfactory function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Beclomethasone | Active comparator | Drug: Beclomethasone, Device: Microsponge84 mcg of Beclomethasone administered twice in each nostril via a microsponge (Day 1 and Day 14) |
| Placebo | Placebo comparator | Other: Placebo, Device: MicrospongePlacebo (0.9% sodium chloride) administered twice in each nostril via a microsponge (Day 1 and Day 14) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Post-COVID hyposmia lasting greater than 3 months following COVID19 by history
- Male or female, aged 18 years or older
Key exclusion criteria (9 listed)
- 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
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 |
|---|---|---|
| Beclomethasone84 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. | Drug | Beclomethasone |
| PlaceboPlacebo (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. | Other | Placebo |
| MicrospongeDrug delivery using chitosan-based biocompatible microsponge | Device | Beclomethasone, Placebo |
Primary outcome
Percentage of Participants Achieving MCID (Minimal Clinically Important Difference) on the Smell Identification Test (SIT)
Time frame: Baseline, 1 month, 3 months
The SIT has a score range of 0 to 40, where a higher score reflects better olfactory function. MCID is defined at a 4 point increase.
1 secondary outcome
Change in Olfactory Quality of Life (QOL) Measured by the Questionnaire on Olfactory Disorders (QOD)
Time frame: Baseline, 1 month, 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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.
Bradley Goldstein, MD, PhD principal investigator
Duke Health
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 Beclomethasone and Microsponge in people with Post Acute Sequelae Covid-19 Hyposmia, run by Duke University 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 9 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 19 Mar 2026. 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 19 Mar 2026). 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?
Percentage of Participants Achieving MCID (Minimal Clinically Important Difference) on the Smell Identification Test (SIT) (time frame: Baseline, 1 month, 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Mar 2026.