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Anti-Inflammatory Agent in Sinusitis (E1416)

This study is enrolling participants by invitation only.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02874144
First Posted: August 22, 2016
Last Update Posted: August 22, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Anju Peters, Northwestern University
  Purpose
To evaluate the efficacy of an anti-inflammatory agent compared with placebo in relieving signs and symptoms of disease in patients with sinusitis.

Condition Intervention Phase
Nasal Polyps Drug: AZ compound Other: Collection of Biological Specimens Drug: Intranasal corticosteroid Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2A, Single-Center, Randomized, Placebo-Controlled, Double-Blind Study to Assess the Efficacy of an Anti-Inflammatory Agent in Patients With Sinusitis

Resource links provided by NLM:


Further study details as provided by Anju Peters, Northwestern University:

Primary Outcome Measures:
  • Sinusitis Score [ Time Frame: 5 months ]
    change in sinusitis score compared to baseline


Estimated Enrollment: 60
Study Start Date: June 2016
Estimated Study Completion Date: August 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AZ Compound
40 mg 12 weeks TID po
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
Other Name: Biomarkers
Drug: Intranasal corticosteroid
QD Nasal Spray
Other Name: Nasal Steroid (Nasonex, Flonase)
Placebo Comparator: Placebo
40 mg 12 weeks TID po
Other: Collection of Biological Specimens
collection of biomarkers for analysis of nasal disease
Other Name: Biomarkers
Drug: Intranasal corticosteroid
QD Nasal Spray
Other Name: Nasal Steroid (Nasonex, Flonase)

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02874144


Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Anju T Peters, MD Northwestern University
  More Information

Responsible Party: Anju Peters, Principal Investigator, Northwestern University
ClinicalTrials.gov Identifier: NCT02874144     History of Changes
Other Study ID Numbers: E1416 Sinus
First Submitted: July 26, 2016
First Posted: August 22, 2016
Last Update Posted: August 22, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Sinusitis
Nasal Polyps
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Polyps
Pathological Conditions, Anatomical
Anti-Inflammatory Agents