Phase 2
N=43
Anti-Inflammatory Agent in Sinusitis
Nasal Polyps
Bottom Line
View on ClinicalTrials.gov: NCT02874144 ↗Enrolled (actual)
43
Serious AEs
4.7%
Results posted
May 2022
Primary outcome: Primary: TOTAL POLYP SCORE (TPS) — 4.67; 5.24 units on a scale — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- AZ compound (Drug); Collection of Biological Specimens (Other); Intranasal corticosteroid (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Northwestern University
- Primary completion
- Jan 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY TOTAL POLYP SCORE (TPS) |
4.67; 5.24 | <0.05 sig |
| PRIMARY Sinus CT Scan Scores by Lund-Mackay Scores |
17.44; 15.53; 18.25; 16.33 | — |
| PRIMARY BSIT (Brief Smell Identification Test) |
5.75; 5.20; 6.92; 5.80 | — |
| SECONDARY SNOT-22 (Sino-Nasal Outcome Test-22) Score |
33.73; 40.41; 26.07; 36.13 | — |
| SECONDARY Visual Analog Scale (VAS) |
5.57; 5.70; 4.75; 4.74 | — |
Summary
To evaluate the efficacy of an anti-inflammatory agent compared with placebo in relieving signs and symptoms of disease in patients with sinusitis.
Eligibility Criteria
Inclusion Criteria
- Females must have a negative urine pregnancy test at screening unless documented to have a hysterectomy or be postmenopausal.
Exclusion Criteria
- Inability or unwillingness of a participant to give written informed consent or comply with study protocol
- Use of any investigational drugs within 30 days of screening.
- Acute infection needing antibiotic treatment at screening.
Data sourced from ClinicalTrials.gov (NCT02874144). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.