Radiologic Scoring of Patients With Chronic Sinusitis and Nasal Polyps

May 31, 2017 updated by: Heba Abdel aal Mekhamar Abdel aal, Assiut University

Effects of Hypertonic Saline and Fluticasone Nasal Sprays on Radiologic Scoring of Patients With Chronic Sinusitis and Nasal Polyps

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: hypertonic saline
nasal spray will be used twice daily
Drug: Hypertonic saline
nasal spray
ACTIVE_COMPARATOR: fluticasone
nasal spray will be used once daily
Drug: Fluticasone Nasal
nasal spray

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

June 1, 2017

Primary Completion (ANTICIPATED)

June 1, 2018

Study Completion (ANTICIPATED)

July 1, 2018

Study Registration Dates

First Submitted

May 31, 2017

First Submitted That Met QC Criteria

May 31, 2017

First Posted (ACTUAL)

June 2, 2017

Study Record Updates

Last Update Posted (ACTUAL)

June 2, 2017

Last Update Submitted That Met QC Criteria

May 31, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSCS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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