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Comparison of Nasal Steroids After FESS in CRSwNP
N/A
Waitlist Available
Led By R. Peter Manes, MD
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
* Adult patients who have had FESS for CRSwNP within the study period
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months post-op
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group
Summary
The purpose of this study is to compare intranasal fluticasone spray with budesonide nasal saline rinses in both the upright and head forward positions in patients who have had functional endoscopic sinus surgery (FESS) for chronic rhinosinusitis with nasal polyposis (CRSwNP) and measure differences in Sinonasal Outcome Test-22 (SNOT-22) scores and Lund- Kennedy scores on rigid nasal endoscopy at time points 1 week, 3 weeks, 6 weeks, 2 months, 4 months, and 6 months post-op.
Eligible Conditions
- Sinusitis
- Prophylaxis of Nasal Polyps
- Sinus Infection
- Nasal Polyps
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months post-op
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months post-op
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
SNOT-22 Scores
Secondary study objectives
Lund-Kennedy Scoring for Nasal Endoscopy
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Active Control
Group I: budesonide head forwardActive Control1 Intervention
Group three will be prescribed budesonide respules (0.5 mg/2mL) to use instill into each nostril in the head forward position two times per day with their head angled downwards by having their head lean forward off the side of a bed.
Group II: budesonide respule in head uprightActive Control1 Intervention
Group two will be prescribed budesonide respules (0.5 mg/2mL) to instill into each nostril in the upright position two times per day
Group III: fluticasone nasal sprayActive Control1 Intervention
Group one will be prescribed fluticasone nasal spray ( to use 2-50 mcg sprays to each nostril two times per day)
Find a Location
Who is running the clinical trial?
Yale UniversityLead Sponsor
1,930 Previous Clinical Trials
3,033,426 Total Patients Enrolled
R. Peter Manes, MDPrincipal InvestigatorYale University School of Medicine, Asst Professor