Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
43 participants
INTERVENTIONAL
2016-06-20
2020-08-10
Brief Summary
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Detailed Description
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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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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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AZ Compound
40 mg 12 weeks TID po
AZ compound
40 mg three times daily po for 12 weeks
Collection of Biological Specimens
collection of biomarkers for analysis of nasal disease
Intranasal corticosteroid
QD Nasal Spray
Placebo
40 mg 12 weeks TID po
Collection of Biological Specimens
collection of biomarkers for analysis of nasal disease
Intranasal corticosteroid
QD Nasal Spray
Placebo
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
Collection of Biological Specimens
collection of biomarkers for analysis of nasal disease
Intranasal corticosteroid
QD Nasal Spray
Placebo
looks like AZ compound, made by same company, double blind. 40 mg three times daily po for 12 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
2. Use of any investigational drugs within 30 days of screening.
3. Acute infection needing antibiotic treatment at screening.
18 Years
70 Years
ALL
No
Sponsors
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Northwestern University
OTHER
Responsible Party
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Anju Peters
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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E1416 Sinus
Identifier Type: -
Identifier Source: org_study_id
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