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

Deraya University

Status and phase: Completed; Phase 2; Phase 1

Conditions: Smell Loss

Treatments: Drug: Prednisolone

Study type: Interventional

Funder types: Other

Identifiers

NCT05328414

Pinsfilm

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 2 patient groups, including a placebo group

Placebo group

Placebo Comparator group

Treatment:

Drug: Prednisolone

steroid based intranasal film

Experimental group

Treatment:

Drug: Prednisolone