Effectiveness of Mometasone Nasal Irrigation for Chronic Rhinosinusitis
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|ClinicalTrials.gov Identifier: NCT03705793|
Recruitment Status : Completed
First Posted : October 15, 2018
Last Update Posted : May 19, 2020
|Condition or disease||Intervention/treatment||Phase|
|Chronic Rhinosinusitis (Diagnosis) Allergic Rhinosinusitis Chronic Eosinophilic Rhinosinusitis||Drug: Mometasone Furoate Nasal Irrigation Drug: Mometasone Nasal Spray||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||43 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Effectiveness of Mometasone Nasal Irrigation for Chronic Rhinosinusitis|
|Actual Study Start Date :||January 1, 2019|
|Actual Primary Completion Date :||February 15, 2020|
|Actual Study Completion Date :||March 15, 2020|
Experimental: Mometasone Furoate Nasal Irrigation
The study intervention will be mometasone furoate powder (1.2 mg/capsule) and placebo nasal spray. The placebo nasal spray will contain the same inert ingredients found in MF nasal spray: glycerin, microcrystalline cellulose and carboxymethylcellulose, sodium citrate, citric acid, benzalkonium chloride, and polysorbate 80. The placebo nasal spray will be packaged identically to the mometasone nasal spray. Participants will be required to dissolve the contents of two capsules into an 8-ounce (240 mL) sinus rinse bottle along with the saline rinse. All participants will be instructed to perform the following once daily: irrigation of both right and left nasal cavity with one-half of the contents of the nasal rinse followed by 2 sprays per nostril of the nasal spray.
Drug: Mometasone Furoate Nasal Irrigation
Participants will undergo an 8-week treatment course that includes nasal saline irrigation with mometasone powder and placebo nasal spray.
Active Comparator: Mometasone Nasal Spray
The study intervention will be mometasone nasal spray (50 mcg/spray) and placebo nasal irrigation. The placebo will contain lactose monohydrate and will be supplied in capsules identical to the budesonide capsules. Participants will be required to dissolve the contents of the two capsules into an 8-ounce (240 mL) sinus rinse bottle along with the saline rinse. All participants will be instructed to perform the following once daily: irrigation of both right and left nasal cavity with one-half of the contents of the nasal rinse followed by 2 sprays per nostril of the nasal spray.
Drug: Mometasone Nasal Spray
Participants will undergo an 8-week treatment course that includes placebo saline irrigation with mometasone nasal spray.
Other Name: Nasonex
- Change in Sino-Nasal Outcome Test scores (SNOT-22) [ Time Frame: Baseline, Week 2, Week 4, Week 6, Week 8 ]Within- and between participant changes in Sino-Nasal Outcome Test scores (SNOT-22) scores pre- and post-treatment. The Sino-Nasal Outcome Test asks subjects to rate how "bad" their rhinosinusitis by using a 0-5 point scale with 0=no problem, 1=very mild problem, 2=mild or slight problem, 3=moderate problem, 4=severe problem, 5=problem as bad as it can be.
- Change in Clinical Global Impression Scale (CGI) [ Time Frame: Week 8 ]CGI asks subjects to rate their overall response to treatment using a 7-point Likert scale with anchors of 1=very much improved, 4=no change, and 7=very much worse.
- Nasal Endoscopic Findings [ Time Frame: Baseline, Week 8 ]A board-certified otolaryngologist will perform a nasal endoscopic examination pre- and post-intervention and findings recorded using the Lund-Kennedy grading system.
- Radiologic Findings [ Time Frame: Baseline, Week 8 ]Radiologic examinations, including CT scans of the paranasal sinuses, are not required for study enrollment. However, if participants receive paranasal sinus CT scans as part of their clinical work-up, the radiologic images will be reviewed and findings recorded using the Lund-McKay grading system. The radiologic data may possibly be included in the data analysis.
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): NCT03705793
|United States, Missouri|
|Washington University School of Medicine|
|Saint Louis, Missouri, United States, 63110|
|Saint Louis, Missouri, United States, 63110|
|Principal Investigator:||Jay F Piccirillo, MD||Washington University School of Medicine|