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budesonide head forward for Sinus Infection

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

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
  • Sinus Infection
  • Nasal Polyps

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months post-op
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months post-op for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
SNOT-22 Scores
Secondary outcome measures
Lund-Kennedy Scoring for Nasal Endoscopy

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)

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Who is running the clinical trial?

Yale UniversityLead Sponsor
1,907 Previous Clinical Trials
3,019,017 Total Patients Enrolled
R. Peter Manes, MDPrincipal InvestigatorYale University School of Medicine, Asst Professor
~3 spots leftby Sep 2025
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