Anti-Inflammatory Agent in Sinusitis

NCT ID: NCT02874144

Last Updated: 2022-05-25

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-20

Study Completion Date

2020-08-10

Brief Summary

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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

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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

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Nasal Polyps

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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AZ Compound

40 mg 12 weeks TID po

Group Type EXPERIMENTAL

AZ compound

Intervention Type DRUG

40 mg three times daily po for 12 weeks

Collection of Biological Specimens

Intervention Type OTHER

collection of biomarkers for analysis of nasal disease

Intranasal corticosteroid

Intervention Type DRUG

QD Nasal Spray

Placebo

40 mg 12 weeks TID po

Group Type PLACEBO_COMPARATOR

Collection of Biological Specimens

Intervention Type OTHER

collection of biomarkers for analysis of nasal disease

Intranasal corticosteroid

Intervention Type DRUG

QD Nasal Spray

Placebo

Intervention Type DRUG

looks like AZ compound, made by same company, double blind. 40 mg three times daily po for 12 weeks

Interventions

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AZ compound

40 mg three times daily po for 12 weeks

Intervention Type DRUG

Collection of Biological Specimens

collection of biomarkers for analysis of nasal disease

Intervention Type OTHER

Intranasal corticosteroid

QD Nasal Spray

Intervention Type DRUG

Placebo

looks like AZ compound, made by same company, double blind. 40 mg three times daily po for 12 weeks

Intervention Type DRUG

Other Intervention Names

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Biomarkers Nasal Steroid (Nasonex, Flonase)

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Anju Peters

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anju T Peters, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

References

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Price CPE, Guo A, Stevens WW, Cousens L, Vu TT, Suh LA, Erickson KA, Conley D, Grammer LC, Kern RC, Tan BK, Kato A, Schleimer RP, Smith SS, Welch KC, Peters AT. Efficacy of an oral CRTH2 antagonist (AZD1981) in the treatment of chronic rhinosinusitis with nasal polyps in adults: A randomized controlled clinical trial. Clin Exp Allergy. 2022 Jul;52(7):859-867. doi: 10.1111/cea.14158. Epub 2022 May 18.

Reference Type DERIVED
PMID: 35524339 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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E1416 Sinus

Identifier Type: -

Identifier Source: org_study_id

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