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Preparation and Characterization Intranasal Film Loaded With Steroid as a Local Treatment of Anosmia in Compare to Insulin Intranasal Film

Primary Purpose

Smell Loss

Status
Completed
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Prednisolone
Sponsored by
Deraya University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Smell Loss

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  1. Patients with chronic sinusitis.
  2. Patients with acute allergic rhinitis.
  3. Patients' nasal polyposis
  4. Patients with history of nasal surgery, severe head trauma or any medical condition that may affect sense of smell.
  5. Patient poly morbidities or poly pharmacy.
  6. Elder, pregnant, or nursing woman.
  7. Patients with chronic diseases.
  8. Autoimmune diseases.
  9. Patient suffering end organ problems.

Sites / Locations

  • Soad A. Mohamad

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo group

steroid based intranasal film

Arm Description

Outcomes

Primary Outcome Measures

Smell restoring
Discrmination test; to recogonize the odd odor three times trial
Smell restoring
Sniffs test; to recogonize the first concentration he could identify

Secondary Outcome Measures

inflammation
to measure the extent of inflammation the reddness and size

Full Information

First Posted
March 27, 2022
Last Updated
May 31, 2023
Sponsor
Deraya University
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1. Study Identification

Unique Protocol Identification Number
NCT05328414
Brief Title
Preparation and Characterization Intranasal Film Loaded With Steroid as a Local Treatment of Anosmia in Compare to Insulin Intranasal Film
Official Title
Steroid Loaded Intranasal Films as a Local Treatment of Anosmia
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
March 18, 2023 (Actual)
Study Completion Date
May 20, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Deraya University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. this record will modify the first formulation by addition certain concentration of steroid.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smell Loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Title
steroid based intranasal film
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Prednisolone
Intervention Description
intranasal fast dissolving film to be applied intranasal. it contains 0.005 mg Presdnisolone
Primary Outcome Measure Information:
Title
Smell restoring
Description
Discrmination test; to recogonize the odd odor three times trial
Time Frame
three week
Title
Smell restoring
Description
Sniffs test; to recogonize the first concentration he could identify
Time Frame
three week
Secondary Outcome Measure Information:
Title
inflammation
Description
to measure the extent of inflammation the reddness and size
Time Frame
three weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. Patients with chronic diseases. Autoimmune diseases. Patient suffering end organ problems.
Facility Information:
Facility Name
Soad A. Mohamad
City
Minya
State/Province
المنيا
ZIP/Postal Code
05673
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Preparation and Characterization Intranasal Film Loaded With Steroid as a Local Treatment of Anosmia in Compare to Insulin Intranasal Film

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