Clinical Assessment of Insulin Fast Dissolving Film in Treatment of Post Infection Anosmia

• Sponsor: Soad Ali (Other)
• Overall Status: Completed
• CT.gov ID: NCT04657809
• Collaborator: Minia University (Other)
• Enrollment: 40
• Location: 1
• Arms: 2
• Actual Duration (Months): 5.6
• Patients Per Site Per Month: 7.2

Study Details

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

1. Threshold test

2. identification test.

Condition or Disease	Intervention/Treatment	Phase
Anosmia	Combination Product: Insulin film; Device: Fast dissolving film	Phase 2

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Treatment
• 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."
• Actual Study Start Date: Oct 1, 2020
• Actual Primary Completion Date: Feb 18, 2021
• Actual Study Completion Date: Mar 20, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Insulin fast dissolving film Formulated bioadhesive fast dissolving film contains 100IU of insulin	Combination Product: Insulin film; Insulin suspension vials; Device: Fast dissolving film; Fast dissolving film
Placebo Comparator: Plain fast dissolving film Formulated bioadhesive fast dissolving film contains no drug	Combination Product: Insulin film; Insulin suspension vials; Device: Fast dissolving film; Fast dissolving film

Outcome Measures

Primary Outcome Measures

1. Smell sensation improvement [4 weeks]

   By decrease the threshold sensation with butanol test

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• anosmia post covid-19 infection

Exclusion Criteria:

• nasal polyps or fractions or syrgery in nose from 6 months or less

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Soad	Minya		Egypt	05637

Sponsors and Collaborators

• Soad Ali
• Minia University

Investigators

• Study Director: Soad Mohamed, Deraya

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Soad Ali, Assistant Professor, Deraya University
• ClinicalTrials.gov Identifier: NCT04657809
• Other Study ID Numbers: S85insu23fdf
• First Posted: Dec 8, 2020
• Last Update Posted: Oct 26, 2021
• Last Verified: Oct 1, 2021

• 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
• Additional relevant MeSH terms: Anosmia; Insulin

Study Results

No Results Posted as of Oct 26, 2021