Clinical Assessment of Insulin Fast Dissolving Film in Treatment of Post Infection Anosmia
Primary Purpose
Anosmia
Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Insulin film
Fast dissolving film
Sponsored by
About this trial
This is an interventional treatment trial for Anosmia
Eligibility Criteria
Inclusion Criteria:
- anosmia post covid-19 infection
Exclusion Criteria:
- nasal polyps or fractions or syrgery in nose from 6 months or less
Sites / Locations
- Soad
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Insulin fast dissolving film
Plain fast dissolving film
Arm Description
Formulated bioadhesive fast dissolving film contains 100IU of insulin
Formulated bioadhesive fast dissolving film contains no drug
Outcomes
Primary Outcome Measures
Smell sensation improvement
By decrease the threshold sensation with butanol test
Secondary Outcome Measures
Full Information
NCT ID
NCT04657809
First Posted
December 2, 2020
Last Updated
October 25, 2021
Sponsor
Soad Ali
Collaborators
Minia University
1. Study Identification
Unique Protocol Identification Number
NCT04657809
Brief Title
Clinical Assessment of Insulin Fast Dissolving Film in Treatment of Post Infection Anosmia
Official Title
"Insulin Fast Dissolving Film for Intranasal Delivery Via Olfactory Region, a Promising Approach for the Treatment of Anosmia in COVID 19 Patients: Design, In-vitro Characterization and Clinical Evaluation."
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
February 18, 2021 (Actual)
Study Completion Date
March 20, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Soad Ali
Collaborators
Minia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
The study aimed to investigate the efficacy of insulin in a new dosage form ( fast dissolving film) in treatment of anosmia in patients post infested with Covid-19. The study implication based in two methods evaluations
Threshold test
identification test.
Detailed Description
This study was designed to improve smell disorders after corona infection that is very anxious for all patients.
Inclusion criteria were loss of smell, post covid-19 infection, age from 18 to 70 years and accept sharing and follow up.
The application of dosage form by ENT specialist at otorhinolaryngology clinic at Minia University hospital. Dose was 100iu of insulin 3 times weekly for 4 weeks. The new dosage form with insulin was compared with a placebo to ensure statistical improvement.
The tests were performed in each visit. Primary outcome was the improvement of smell sensors in those patients
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anosmia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Insulin fast dissolving film
Arm Type
Experimental
Arm Description
Formulated bioadhesive fast dissolving film contains 100IU of insulin
Arm Title
Plain fast dissolving film
Arm Type
Placebo Comparator
Arm Description
Formulated bioadhesive fast dissolving film contains no drug
Intervention Type
Combination Product
Intervention Name(s)
Insulin film
Intervention Description
Insulin suspension vials
Intervention Type
Device
Intervention Name(s)
Fast dissolving film
Intervention Description
Fast dissolving film
Primary Outcome Measure Information:
Title
Smell sensation improvement
Description
By decrease the threshold sensation with butanol test
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
anosmia post covid-19 infection
Exclusion Criteria:
nasal polyps or fractions or syrgery in nose from 6 months or less
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Soad Mohamed
Organizational Affiliation
Deraya
Official's Role
Study Director
Facility Information:
Facility Name
Soad
City
Minya
ZIP/Postal Code
05637
Country
Egypt
12. IPD Sharing Statement
Citations:
PubMed Identifier
36063364
Citation
Webster KE, O'Byrne L, MacKeith S, Philpott C, Hopkins C, Burton MJ. Interventions for the prevention of persistent post-COVID-19 olfactory dysfunction. Cochrane Database Syst Rev. 2022 Sep 5;9(9):CD013877. doi: 10.1002/14651858.CD013877.pub3.
Results Reference
derived
PubMed Identifier
36062970
Citation
O'Byrne L, Webster KE, MacKeith S, Philpott C, Hopkins C, Burton MJ. Interventions for the treatment of persistent post-COVID-19 olfactory dysfunction. Cochrane Database Syst Rev. 2022 Sep 5;9(9):CD013876. doi: 10.1002/14651858.CD013876.pub3.
Results Reference
derived
Learn more about this trial
Clinical Assessment of Insulin Fast Dissolving Film in Treatment of Post Infection Anosmia
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