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

• Sponsor: Deraya University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05328414
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 14.6
• Patients Per Site Per Month: 6.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Smell Loss	Drug: Prednisolone	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Steroid Loaded Intranasal Films as a Local Treatment of Anosmia
• Actual Study Start Date: Mar 1, 2022
• Anticipated Primary Completion Date: Mar 18, 2023
• Anticipated Study Completion Date: May 20, 2023

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo group	Drug: Prednisolone; intranasal fast dissolving film to be applied intranasal. it contains 0.005 mg Presdnisolone
Experimental: steroid based intranasal film	Drug: Prednisolone; intranasal fast dissolving film to be applied intranasal. it contains 0.005 mg Presdnisolone

Outcome Measures

Primary Outcome Measures

1. Smell restoring [three week]

   Discrmination test; to recogonize the odd odor three times trial

2. Smell restoring [three week]

   Sniffs test; to recogonize the first concentration he could identify

Secondary Outcome Measures

1. inflammation [three weeks]

   to measure the extent of inflammation the reddness and size

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Soad A. Mohamad	Minya	المنيا	Egypt	05673

Sponsors and Collaborators

• Deraya University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Deraya University
• ClinicalTrials.gov Identifier: NCT05328414
• Other Study ID Numbers: Pinsfilm
• First Posted: Apr 14, 2022
• Last Update Posted: Apr 14, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Anosmia; Prednisolone

Study Results

No Results Posted as of Apr 14, 2022