Anti-Inflammatory Agent in Sinusitis
E1416
A Phase 2A, Single-Center, Randomized, Placebo-Controlled, Double-Blind Study to Assess the Efficacy of an Anti-Inflammatory Agent in Patients With Sinusitis
1 other identifier
interventional
43
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jun 2016
Typical duration for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 20, 2016
CompletedFirst Submitted
Initial submission to the registry
July 26, 2016
CompletedFirst Posted
Study publicly available on registry
August 22, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 7, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 10, 2020
CompletedResults Posted
Study results publicly available
May 25, 2022
CompletedMay 25, 2022
May 1, 2022
3.6 years
July 26, 2016
April 8, 2021
May 4, 2022
Conditions
Outcome Measures
Primary Outcomes (3)
TOTAL POLYP SCORE (TPS)
Measure Description: Measurement of Primary outcome- 0-4 scale in each nostril, total is 8. The total polyp score is the sum of the right and left nasal polyp score. Maximum is 8, minimum is 0. Higher score indicates worse disease. 0 =No polyps 1=Small polyps in the middle meatus not reaching below the inferior border of the middle turbinate 2=Polyps reaching the lower border of the middle turbinate or polyp medial to the middle turbinate 3 = Large polyps reaching the lower border of the inferior turbinate 4 =Large polyps causing complete obstruction. The primary outcome measured change in polyp size and secondary outcomes included change in radiographic severity of sinus disease, quality of life, and nasal symptoms as measured by Sino Nasal Outcome Test-22 (SNOT-22) and sense of smell by Brief Smell Identification Test (B-SIT) at 12 weeks in the AZD1981 group vs. the placebo. These were done at the baseline visit and the Week 12 visit.
Baseline and Week 12
Sinus CT Scan Scores by Lund-Mackay Scores
Measurement of secondary outcome: sinus CT scan scores by Lund-Mckay scores. We measured sinus radiographic severity with Lund-Mackay scores of 0 to 24. 0 was the least severe and 24 was the most severe. This secondary outcomes included change in radiographic severity of sinus disease, as measured by sinus CT scan scores at baseline and 12 weeks in the AZD1981 group vs. the placebo group.
Baseline and Week 12
BSIT (Brief Smell Identification Test)
Measurement of secondary outcome- BSIT (brief smell identification test) is a 12-item test measuring sense of smell. This is a multiple choice test with one correct answer out of four possible answer choices. This test features distinct types of smells. Minimum score: 0/12, which indicates that none of the correct answers were chosen on the 12-item test. Maximum score: 12/12, which indicates that all of the correct answers were chosen on the 12-item test. The higher the score, the better the outcome. Only one out of the four possible answer choices for each multiple choice question is correct. There are no subscales. This secondary outcome measures sense of smell by Brief Smell Identification Test (B-SIT) at baseline (visit 1) and 12 weeks (visit 5) in the AZD1981 group vs. the placebo group.
Baseline and Week 12
Secondary Outcomes (2)
SNOT-22 (Sino-Nasal Outcome Test-22) Score
Baseline and Week 12
Visual Analog Scale (VAS)
Baseline and Week 12
Study Arms (2)
AZ Compound
EXPERIMENTAL40 mg 12 weeks TID po
Placebo
PLACEBO COMPARATOR40 mg 12 weeks TID po
Interventions
collection of biomarkers for analysis of nasal disease
QD Nasal Spray
looks like AZ compound, made by same company, double blind. 40 mg three times daily po for 12 weeks
Eligibility Criteria
You may qualify if:
- \. Females must have a negative urine pregnancy test at screening unless documented to have a hysterectomy or be postmenopausal.
You may not qualify if:
- Inability or unwillingness of a participant to give written informed consent or comply with study protocol
- Use of any investigational drugs within 30 days of screening.
- Acute infection needing antibiotic treatment at screening.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 35524339DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Anju Peters
- Organization
- Northwestern
Study Officials
- PRINCIPAL INVESTIGATOR
Anju T Peters, MD
Northwestern University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 26, 2016
First Posted
August 22, 2016
Study Start
June 20, 2016
Primary Completion
January 7, 2020
Study Completion
August 10, 2020
Last Updated
May 25, 2022
Results First Posted
May 25, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share