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Mometasone vs Budesonide in CRS With Polyposis

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ClinicalTrials.gov Identifier: NCT03323866
Recruitment Status : Recruiting
First Posted : October 27, 2017
Last Update Posted : January 10, 2018
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The principal objective is to compare the use of mometasone nasal spray to budesonide irrigations in patients suffering from CRSwNP who have never been operated.

Condition or disease Intervention/treatment Phase
Chronic Rhinosinusitis (Diagnosis), Nasal Polyposis Drug: Budesonide 0.5 MG/ML Drug: Mometasone nasal spray Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled trial comparing mometasone nasal spray to budesonide irrigations for treatment of chronic rhinosinusitis with nasal polyposis
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controled Double-blinded Study Comparing Mometasone Nasal Spray to Budesonide Irrigations in Patients With Chronic Rhinosinusitis With Nasal Polyposis
Actual Study Start Date : May 1, 2017
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Budesonide
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Mometasone nasal spray
Mometasone nasal spray 50 mcg/dose, 2 sprays/nostril twice daily x 3 months Patients will also be taking Sinus Rinse once daily throughout the study period
Drug: Mometasone nasal spray
Mometasone 50 mcg/spray 2 sprays twice daily
Experimental: Budesonide irrigation
2 cc budesonide nebule (0,5 mg/cc) incorporated to 240 of saline water (Sinus Rinse) to be taken on a daily basis x 3 months
Drug: Budesonide 0.5 MG/ML
2 cc nebule of budesonide in 240 cc of saline water (Sinus Rinse) once daily


Outcome Measures

Primary Outcome Measures :
  1. Disease specific quality of life questionnaire [ Time Frame: 3 months after beginning of treatment ]
    SinoNasal Outcome Test - 22 This is a symptom score ranging from 0 to 110 points, 0 representing the absence of nasal symptoms and 110 being the most severe symptoms.


Secondary Outcome Measures :
  1. Endoscopic evaluation of the nasal cavities [ Time Frame: 3 months after beginning of treatment ]
    Lund Kennedy Endoscopic Score This is a score evaluating the healing of sinonasal cavities from 0 point (normal and healthy looking cavity) to 20 points (the most diseased cavity).


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:   Yes
Criteria

Inclusion Criteria:

  • Diagnosis of chronic rhinosinusitis with nasal polyps
  • Absence of active infection at start of study

Exclusion Criteria:

  • Diagnosis of chronic rhinosinusitis without nasal polyps
  • Diagnosis of recurrent acute bacterial rhinosinusitis
  • Previous sinus surgery (septal of inferior turbinate surgeries are not considered sinus surgeries)
  • Cystic fibrosis or ciliary dyskinesia
  • Allergy to corticosteroids
  • Pregnant or lactating women
  • Contra-indication to intranasal steroids
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): NCT03323866


Contacts
Contact: Marie Bussieres, MD FRCSC 819-346-1110 ext 14901 marie.bussieres@usherbrooke.ca

Locations
Canada, Quebec
Université de Sherbrooke Recruiting
Sherbrooke, Quebec, Canada, J1H 5N4
Contact: Marie Bussieres, MD FRCSC    819-346-1110 ext 14901    marie.bussieres@usherbrooke.ca   
Sponsors and Collaborators
Université de Sherbrooke
More Information

Responsible Party: Marie Bussières, Otolaryngologist, Université de Sherbrooke
ClinicalTrials.gov Identifier: NCT03323866     History of Changes
Other Study ID Numbers: 2017-1569
First Posted: October 27, 2017    Key Record Dates
Last Update Posted: January 10, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Sinusitis
Colorectal Neoplasms
Nasopharyngeal Neoplasms
Nasal Polyps
Chronic Disease
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Polyps
Pathological Conditions, Anatomical
Disease Attributes
Pathologic Processes