Anti-Inflammatory Agent in Sinusitis (E1416)

Northwestern University

Status and phase: Completed; Phase 2

Conditions: Nasal Polyps

Treatments: Drug: Placebo; Other: Collection of Biological Specimens; Drug: AZ compound; Drug: Intranasal corticosteroid

Study type: Interventional

Funder types: Other

Identifiers

NCT02874144

E1416 Sinus

Details and patient eligibility

About

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

Full 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.

Enrollment: 43 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Females must have a negative urine pregnancy test at screening unless documented to have a hysterectomy or be postmenopausal.

Exclusion criteria

1. Inability or unwillingness of a participant to give written informed consent or comply with study protocol
2. Use of any investigational drugs within 30 days of screening.
3. Acute infection needing antibiotic treatment at screening.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

43 participants in 2 patient groups, including a placebo group

AZ Compound

Experimental group

Description:

40 mg 12 weeks TID po

Treatment:

Drug: Intranasal corticosteroid

Drug: AZ compound

Other: Collection of Biological Specimens

Placebo

Placebo Comparator group

Description:

40 mg 12 weeks TID po

Treatment:

Drug: Intranasal corticosteroid

Drug: Placebo

Other: Collection of Biological Specimens