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Anti-Inflammatory Agent in Sinusitis (E1416)

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.
 
ClinicalTrials.gov Identifier: NCT02874144
Recruitment Status : Enrolling by invitation
First Posted : August 22, 2016
Last Update Posted : October 7, 2019
Sponsor:
Information provided by (Responsible Party):
Anju Peters, Northwestern University

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

Condition or disease Intervention/treatment Phase
Nasal Polyps Drug: AZ compound Other: Collection of Biological Specimens Drug: Intranasal corticosteroid Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
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
Study Start Date : June 2016
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sinusitis

Arm Intervention/treatment
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)

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




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


Secondary Outcome Measures :
  1. visual analog score [ Time Frame: 5 months ]
    scale is from 1 to 10, 10 is most severe. subjects are asked to rate the severity of their symptoms the day of the visit. 1= not severe at all, 10= very severe. This will be compared from baseline to follow up.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
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.

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
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Principal Investigator: Anju T Peters, MD Northwestern University

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Responsible Party: Anju Peters, Principal Investigator, Northwestern University
ClinicalTrials.gov Identifier: NCT02874144    
Other Study ID Numbers: E1416 Sinus
First Posted: August 22, 2016    Key Record Dates
Last Update Posted: October 7, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Sinusitis
Nasal Polyps
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Polyps
Pathological Conditions, Anatomical
Anti-Inflammatory Agents