Preparation and Characterization Intranasal Film Loaded W... | NCT05328414

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

NCT05328414

Sponsor

Deraya University

Status

Completed

Last Update Posted

Jun 1, 2023Actual

Enrollment

200Actual

Phase

Phase 1Phase 2

Conditions

Smell Loss

Interventions

Prednisolone

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2022Actual

Primary Completion Date

Mar 18, 2023Actual

Completion Date

May 20, 2023Actual

First Submitted Date

Mar 27, 2022

First Submission Date that Met QC Criteria

Apr 13, 2022

First Posted Date

Apr 14, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 31, 2023

Last Update Posted Date

Jun 1, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo group	Placebo Comparator		Drug: Prednisolone
steroid based intranasal film	Experimental		Drug: Prednisolone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Prednisolone	Drug	intranasal fast dissolving film to be applied intranasal. it contains 0.005 mg Presdnisolone	Placebo group steroid based intranasal film

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
inflammation	to measure the extent of inflammation the reddness and size	three weeks

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Soad A. Mohamad		Minya	Minya Governorate	05673	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000086582	Anosmia

Ancestor Terms

ID	Term
D000857	Olfaction Disorders
D012678	Sensation Disorders
D009461	Neurologic Manifestations
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011239	Prednisolone

Ancestor Terms

ID	Term
D011246	Pregnadienetriols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids

Browse Leaves

Not provided

Browse Branches

Not provided