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Radiologic Scoring of Patients With Chronic Sinusitis and Nasal Polyps

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ClinicalTrials.gov Identifier: NCT03174483
Recruitment Status : Recruiting
First Posted : June 2, 2017
Last Update Posted : June 2, 2017
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Chronic Sinusitis Drug: Hypertonic saline Drug: Fluticasone Nasal

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
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
Anticipated Study Start Date : June 2017
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sinusitis
U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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

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 Posted: June 2, 2017    Key Record Dates
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:
Nasal Polyps
Chronic Disease
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Pathological Conditions, Anatomical
Disease Attributes
Pathologic Processes
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