Radiologic Scoring of Patients With Chronic Sinusitis and... | NCT03174483

Studies
Radiologic Scoring of Patients With Chronic Sinusitis and Nasal Polyps

NCT03174483

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Jun 2, 2017Actual

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Chronic Sinusitis

Interventions

Hypertonic saline
Fluticasone Nasal

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 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2017Estimated

Primary Completion Date

Jun 2018Estimated

Completion Date

Jul 2018Estimated

First Submitted Date

May 31, 2017

First Submission Date that Met QC Criteria

May 31, 2017

First Posted Date

Jun 2, 2017Actual

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, 2017

Last Update Posted Date

Jun 2, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Heba Abdel aal Mekhamar Abdel aal, principal investigator, Assiut UniversityPrincipal Investigator

Lead Sponsor

Assiut UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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

To detect the effect of hypertonic saline and fluticasone sprays on computed tomography scan of paranasal sinuses of patients having chronic sinusitis and/or nasal polyps.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
hypertonic saline	Experimental	nasal spray will be used twice daily	Drug: Hypertonic saline
fluticasone	Active Comparator	nasal spray will be used once daily	Drug: Fluticasone Nasal

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hypertonic saline	Drug	nasal spray	hypertonic saline
Fluticasone Nasal

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The percentage of patient with normal radiological scoring	the score used is Lund Mackay radiological scoring	1 month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult patients with chronic sinusitis and/or nasal polyps.

Exclusion Criteria:

Patients with previous nasal or sinus surgery.
Patients with sinonasal Malignancy.
Immunocompromised patients.
Patients with ciliary motility disorders.
Pregnant women

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hussein Weshahy, MD	Contact	00201001775898		weshahy_orl@aun.edu.eg
Mohammad Osman, MD	Contact	00201005267182		mohamedosman@aun.edu.eg

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Assiut University	Recruiting	Asyut			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

Intervention Browse Module

MeSH Terms

ID	Term
D012462	Saline Solution, Hypertonic

Ancestor Terms

ID	Term
D006982	Hypertonic Solutions
D012996	Solutions
D004364	Pharmaceutical Preparations

Browse Leaves

Not provided

Browse Branches

Not provided