Trial · NCT02874144

Anti-Inflammatory Agent in Sinusitis

NCT02874144, Phase 2, Completed, Northwestern University; results first posted 2022-05-25

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Anti-Inflammatory Agent in Sinusitis. Trials, record NCT02874144. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02874144

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Anti-Inflammatory Agent in Sinusitis
NCT number: NCT02874144
Status: Completed
Phases: Phase 2
Enrollment: 43 participants, actual
Lead sponsor: Northwestern University
Conditions: Nasal Polyps
Interventions: AZ compound, Collection of Biological Specimens, Intranasal corticosteroid, Placebo
First posted: 2016-08-22
Last updated: 2022-05-25
Results first posted: 2022-05-25

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	TOTAL POLYP SCORE (TPS)	Baseline and Week 12	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.
Primary	Sinus CT Scan Scores by Lund-Mackay Scores	Baseline and Week 12	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.
Primary	BSIT (Brief Smell Identification Test)	Baseline and Week 12	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.
Secondary	SNOT-22 (Sino-Nasal Outcome Test-22) Score	Baseline and Week 12	Measurement of secondary outcome- the SNOT-22 test contains 22 items regarding patient-reported outcomes of sino-nasal symptom severity on a 0-5 scale for each item. 0 is no problem and 5 is problem as bad as it can be, so higher values represent a worse outcome than lower values. The subscale is 0 - 5 of each of the 22 items and the total score is the sum of the subscales of all 22 items. The minimum total score is 0/110. The maximum total score is 110/110. This secondary outcome measured change in patient-reported outcomes of nasal symptoms as measured by Sino Nasal Outcome Test-22 (SNOT-22) over 12 weeks in the AZD1981 group vs. the placebo group.
Secondary	Visual Analog Scale (VAS)	Baseline and Week 12	Measurement of secondary outcome- 0 to 10 scale bilaterally that measures how subjective sinus symptom severity, with 0 being the least troublesome to 10 being the most troublesome over 12 weeks in the AZD1981 group vs. the placebo group.

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	TOTAL POLYP SCORE (TPS)	Baseline and Week 12	The primary outcome was the mean change from baseline to 12 weeks in the size of nasal polyps as measured by the total polyp score in the AZD1981 treated group compared to the placebo-treated group.	units on a scale	MEAN
PRIMARY	Sinus CT Scan Scores by Lund-Mackay Scores	Baseline and Week 12	The secondary outcome was the mean change in Lund-Mackay scores of sinus CT scans from baseline to 12 weeks in the AZD1981 treated group compared to the placebo-treated group.	units on a scale	MEAN
PRIMARY	BSIT (Brief Smell Identification Test)	Baseline and Week 12	The secondary outcome was the mean change from baseline to 12 weeks of BSIT scores in the AZD1981 treated group compared to the placebo-treated group.	units on a scale	MEAN
SECONDARY	SNOT-22 (Sino-Nasal Outcome Test-22) Score	Baseline and Week 12	This secondary outcome was the mean change from baseline to 12 weeks in sinonasal symptoms detailed in the SNOT-22 as measured by the total polyp score in the AZD1981 treated group compared to the placebo-treated group.	units on a scale	MEAN
SECONDARY	Visual Analog Scale (VAS)	Baseline and Week 12	The secondary outcome was the mean change from baseline (visit 1) to 12 weeks (visit 5) of the VAS scores in the AZD1981 treated group compared to the placebo-treated group.	units on a scale	MEAN

Source ClinicalTrials.gov

Results by group18

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
TOTAL POLYP SCORE (TPS)	AZD + INCS		4.67	Standard Error 0.38	units on a scale
TOTAL POLYP SCORE (TPS)	PLACEBO + INCS		5.24	Standard Error 0.36	units on a scale
Sinus CT Scan Scores by Lund-Mackay Scores	AZD + INCS	Visit 1 (Baseline)	17.44	Standard Error 1.38	units on a scale
Sinus CT Scan Scores by Lund-Mackay Scores	PLACEBO + INCS	Visit 1 (Baseline)	15.53	Standard Error 1.43	units on a scale
Sinus CT Scan Scores by Lund-Mackay Scores	AZD + INCS	Visit 5 (12 weeks)	18.25	Standard Error 1.1	units on a scale
Sinus CT Scan Scores by Lund-Mackay Scores	PLACEBO + INCS	Visit 5 (12 weeks)	16.33	Standard Error 1.14	units on a scale
BSIT (Brief Smell Identification Test)	AZD + INCS	Visit 1 (Baseline)	5.75	Standard Error 0.81	units on a scale
BSIT (Brief Smell Identification Test)	PLACEBO + INCS	Visit 1 (Baseline)	5.20	Standard Error 0.88	units on a scale
BSIT (Brief Smell Identification Test)	AZD + INCS	Visit 5 (12 weeks)	6.92	Standard Error 1.12	units on a scale
BSIT (Brief Smell Identification Test)	PLACEBO + INCS	Visit 5 (12 weeks)	5.80	Standard Error 1.22	units on a scale

1 to 10 of 18Source ClinicalTrials.gov

See all 18 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	AZ Compound	22
Overall Study	STARTED	Placebo	21
Overall Study	COMPLETED	AZ Compound	19
Overall Study	COMPLETED	Placebo	16
Overall Study	NOT COMPLETED	AZ Compound	3
Overall Study	NOT COMPLETED	Placebo	5

Source ClinicalTrials.gov

Adverse events6

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Rash	Respiratory, thoracic and mediastinal disorders	AZ+INCS	1	22	1
other	Rash	Respiratory, thoracic and mediastinal disorders	Placebo + INCS	0	21	0
serious	Diverticulitis	Gastrointestinal disorders	AZ+INCS	0	22	0
serious	Diverticulitis	Gastrointestinal disorders	Placebo + INCS	1	21	1
serious	Hypersensitivity	Respiratory, thoracic and mediastinal disorders	AZ+INCS	1	22	1
serious	Hypersensitivity	Respiratory, thoracic and mediastinal disorders	Placebo + INCS	0	21	0

Source ClinicalTrials.gov

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	AZ+INCS	0	22
Total, all-cause mortality	Placebo + INCS	0	21
Total, other adverse events	AZ+INCS	1	22
Total, other adverse events	Placebo + INCS	0	21
Total, serious adverse events	AZ+INCS	1	22
Total, serious adverse events	Placebo + INCS	1	21

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
35524339	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
AZ+INCS vs Placebo + INCS: deaths from any cause	Trial comparisons
AZ+INCS vs Placebo + INCS: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02874144

GET https://conductscience.org/api/trials/v1/NCT02874144/registered

API reference For AI assistants