Smell LossPhase 1/2NCT05328414
Preparation and Characterization Intranasal Film Loaded With Steroid as a Local Treatment of Anosmia in Compare to Insulin Intranasal Film
A Phase 1/2 study testing Prednisolone in people with Smell Loss, run by Deraya University at 1 site in Egypt.
Trial summary
This study is a growing step of phase I study published on March 2021. The study was implicated on Minia university on small scale of patient (20) to investigate the impact of insulin as fast dissolving films for intranasal delivery to treat anosmia in post COVID-19 infections. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Smell Loss
- What is being tested?
- Prednisolone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2022to 20 May 2023
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- All patients' adults aged from 18 years to 50 will included in the study.
- A confirmed case (positive PCR), recovered/discharged (2 negative PCR),
- suffering from sudden recent anosmia or hyposmia with or without loss of taste.
Who cannot join
- Patients with chronic sinusitis.
- Patients with acute allergic rhinitis.
- Patients' nasal polyposis
- Patients with history of nasal surgery, severe head trauma or any medical condition that may affect sense of smell.
- Patient poly morbidities or poly pharmacy.
- Elder, pregnant, or nursing woman.
Show all 9Show fewer
- Patients with chronic diseases.
- Autoimmune diseases.
- Patient suffering end organ problems.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Steroid Loaded Intranasal Films as a Local Treatment of Anosmia
This study is a growing step of phase I study published on March 2021. The study was implicated on Minia university on small scale of patient (20) to investigate the impact of insulin as fast dissolving films for intranasal delivery to treat anosmia in post COVID-19 infections. this record will modify the first formulation by addition certain concentration of steroid.
- Conditions
- Smell Loss
- Being tested
- Prednisolone
- Medical subject headings
- Anosmia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrednisoloneDrug
intranasal fast dissolving film to be applied intranasal. it contains 0.005 mg Presdnisolone
| Study group | Role | What they receive |
|---|---|---|
| Placebo group | Placebo comparator | Not described Receives: Drug: Prednisolone |
| steroid based intranasal film | Experimental | Not described Receives: Drug: Prednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smell restoring
Discrmination test; to recogonize the odd odor three times trial
Measured: three week
Smell restoring
Sniffs test; to recogonize the first concentration he could identify
Measured: three week
Secondary outcomes (1)
inflammation
to measure the extent of inflammation the reddness and size
Measured: three weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2022
- Study start1 Mar 2022
- Primary completion18 Mar 2023
- Study completion20 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smell LossStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Deraya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soad Ali, Deraya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05328414
- Sponsor's protocol ID
- Pinsfilm
- Status last verified
- May 2023
- First submitted
- 27 Mar 2022
- Last updated
- 1 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Steroid Loaded Intranasal Films as a Local Treatment of Anosmia
- ClinicalTrials.gov ID
- NCT05328414
- Acronym / sponsor ID
- Pinsfilm
- Conditions
- Smell Loss
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Deraya UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 18 Mar 2023 (actual)
- Study completion
- 20 May 2023 (actual)
- First posted
- 14 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a growing step of phase I study published on March 2021. The study was implicated on Minia university on small scale of patient (20) to investigate the impact of insulin as fast dissolving films for intranasal delivery to treat anosmia in post COVID-19 infections. this record will modify the first formulation by addition certain concentration of steroid.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo group | Placebo comparator | Drug: Prednisolone |
| steroid based intranasal film | Experimental | Drug: Prednisolone |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- All patients' adults aged from 18 years to 50 will included in the study.
- A confirmed case (positive PCR), recovered/discharged (2 negative PCR),
- suffering from sudden recent anosmia or hyposmia with or without loss of taste.
Key exclusion criteria (9 listed)
- Patients with chronic sinusitis.
- Patients with acute allergic rhinitis.
- Patients' nasal polyposis
- Patients with history of nasal surgery, severe head trauma or any medical condition that may affect sense of smell.
- Patient poly morbidities or poly pharmacy.
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 |
|---|---|---|
| Prednisoloneintranasal fast dissolving film to be applied intranasal. it contains 0.005 mg Presdnisolone | Drug | Placebo group, steroid based intranasal film |
Primary outcome
Smell restoring
Time frame: three week
Discrmination test; to recogonize the odd odor three times trial
Smell restoring
Time frame: three week
Sniffs test; to recogonize the first concentration he could identify
1 secondary outcome
inflammation
Time frame: three weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2023.
- Individual participant dataSharing planned: No
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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 1/2 study testing Prednisolone in people with Smell Loss, run by Deraya University at 1 site in Egypt.
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 3 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 1 Jun 2023. 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 Egypt. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Smell restoring (time frame: three week). The study lists 2 primary outcomes in all. 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 1 Jun 2023.