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

NCT05328414 | Completed Phase 1 DMC

• 1 other identifier: Pinsfilm
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Smell Loss

Outcome Measures

Primary Outcomes (2)

• Smell restoring

  Discrmination test; to recogonize the odd odor three times trial

  three week

• Smell restoring

  Sniffs test; to recogonize the first concentration he could identify

  three week

Secondary Outcomes (1)

• inflammation

  three weeks

Study Arms (2)

Placebo group

PLACEBO COMPARATOR

Drug: Prednisolone

steroid based intranasal film

EXPERIMENTAL

Drug: Prednisolone

Interventions

Prednisolone DRUG

intranasal fast dissolving film to be applied intranasal. it contains 0.005 mg Presdnisolone

Placebo group; steroid based intranasal film

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Deraya University: lead

Study Sites (1)

Soad A. Mohamad

Minya, Minya Governorate, 05673, Egypt

Location

MeSH Terms

Conditions

Anosmia

Interventions

Prednisolone

Condition Hierarchy (Ancestors)

Olfaction Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical professor

Study Record Dates

• First Submitted: March 27, 2022
• First Posted: April 14, 2022
• Study Start: March 1, 2022
• Primary Completion: March 18, 2023
• Study Completion: May 20, 2023
• Last Updated: June 1, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)