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Radiologic Scoring of Patients With Chronic Sinusitis and Nasal Polyps

This study is currently recruiting participants.
Verified May 2017 by Heba Abdel aal Mekhamar Abdel aal, Assiut University
Sponsor:
ClinicalTrials.gov Identifier:
NCT03174483
First Posted: June 2, 2017
Last Update Posted: June 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Heba Abdel aal Mekhamar Abdel aal, Assiut University
  Purpose
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.

Condition Intervention
Chronic Sinusitis Drug: Hypertonic saline Drug: Fluticasone Nasal

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Hypertonic Saline and Fluticasone Nasal Sprays on Radiologic Scoring of Patients With Chronic Sinusitis and Nasal Polyps

Resource links provided by NLM:


Further study details as provided by Heba Abdel aal Mekhamar Abdel aal, Assiut University:

Primary Outcome Measures:
  • The percentage of patient with normal radiological scoring [ Time Frame: 1 month ]
    the score used is Lund Mackay radiological scoring


Estimated Enrollment: 60
Anticipated Study Start Date: June 2017
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03174483


Contacts
Contact: Hussein Weshahy, MD 00201001775898 weshahy_orl@aun.edu.eg
Contact: Mohammad Osman, MD 00201005267182 mohamedosman@aun.edu.eg

Locations
Egypt
Assiut University Recruiting
Assiut, Egypt
Contact: Heba Abdel aal, MBBCh    00201119125556    happydocotor777@gmail.com   
Sponsors and Collaborators
Assiut University
  More Information

Responsible Party: Heba Abdel aal Mekhamar Abdel aal, principal investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03174483     History of Changes
Other Study ID Numbers: HSCS
First Submitted: May 31, 2017
First Posted: June 2, 2017
Last Update Posted: June 2, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Sinusitis
Nasal Polyps
Chronic Disease
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Polyps
Pathological Conditions, Anatomical
Disease Attributes
Pathologic Processes
Fluticasone
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents