NCT02874144

Anti-Inflammatory Agent in Sinusitis

A Phase 2A, Single-Center, Randomized, Placebo-Controlled, Double-Blind Study to Assess the Efficacy of an Anti-Inflammatory Agent in Patients With Sinusitis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Northwestern University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy of an anti-inflammatory agent compared with placebo in relieving signs and symptoms of disease in patients with sinusitis.

Detailed description

This is a Phase 2a, single-center, randomized, placebo-controlled, double-blind study that includes 12 weeks of treatment with experimental drug anti-inflammatory agent or placebo TID administered orally. All subjects will be ≥18 years, have sinusitis with persistent symptoms despite standard of care treatment, and have failed a course of steroids in the past.

Conditions

• Nasal Polyps

Interventions

Type	Name	Description
DRUG	AZ compound	40 mg three times daily po for 12 weeks
OTHER	Collection of Biological Specimens	collection of biomarkers for analysis of nasal disease
DRUG	Intranasal corticosteroid	QD Nasal Spray
DRUG	Placebo	looks like AZ compound, made by same company, double blind. 40 mg three times daily po for 12 weeks

Timeline

• Start date: 2016-06-20
• Primary completion: 2020-01-07
• Completion: 2020-08-10
• First posted: 2016-08-22
• Last updated: 2022-05-25
• Results posted: 2022-05-25