Back to resultsRadiologic Scoring of Patients With Chronic Sinusitis and Nasal Polyps
Primary Purpose
Chronic Sinusitis
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Hypertonic saline
Fluticasone Nasal
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Sinusitis
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
Sites / Locations
- Assiut UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
hypertonic saline
fluticasone
Arm Description
nasal spray will be used twice daily
nasal spray will be used once daily
Outcomes
Primary Outcome Measures
The percentage of patient with normal radiological scoring
the score used is Lund Mackay radiological scoring
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03174483
Brief Title
Radiologic Scoring of Patients With Chronic Sinusitis and Nasal Polyps
Official Title
Effects of Hypertonic Saline and Fluticasone Nasal Sprays on Radiologic Scoring of Patients With Chronic Sinusitis and Nasal Polyps
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 2017 (Anticipated)
Primary Completion Date
June 2018 (Anticipated)
Study Completion Date
July 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Sinusitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
hypertonic saline
Arm Type
Experimental
Arm Description
nasal spray will be used twice daily
Arm Title
fluticasone
Arm Type
Active Comparator
Arm Description
nasal spray will be used once daily
Intervention Type
Drug
Intervention Name(s)
Hypertonic saline
Intervention Description
nasal spray
Intervention Type
Drug
Intervention Name(s)
Fluticasone Nasal
Intervention Description
nasal spray
Primary Outcome Measure Information:
Title
The percentage of patient with normal radiological scoring
Description
the score used is Lund Mackay radiological scoring
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hussein Weshahy, MD
Phone
00201001775898
Email
weshahy_orl@aun.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Mohammad Osman, MD
Phone
00201005267182
Email
mohamedosman@aun.edu.eg
Facility Information:
Facility Name
Assiut University
City
Assiut
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heba Abdel aal, MBBCh
Phone
00201119125556
Email
happydocotor777@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Radiologic Scoring of Patients With Chronic Sinusitis and Nasal Polyps
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