Nasal PolypsPhase 2E1416NCT02874144

Anti-Inflammatory Agent in Sinusitis

A Phase 2 study testing AZ compound, Collection of Biological Specimens and Intranasal corticosteroid in people with Nasal Polyps, run by Northwestern University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To evaluate the efficacy of an anti-inflammatory agent compared with placebo in relieving signs and symptoms of disease in patients with sinusitis. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Nasal Polyps
What is being tested?: AZ compound, Collection of Biological Specimens and Intranasal corticosteroid
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 43 participants
Where: No sites listed yet
Study dates: 20 Jun 2016to 10 Aug 2020
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

1. Females must have a negative urine pregnancy test at screening unless documented to have a hysterectomy or be postmenopausal.

Who cannot join

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.

About this study

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

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

Read the 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.

Conditions: Nasal Polyps
Being tested: AZ compound, Collection of Biological Specimens, Intranasal corticosteroid, Placebo
Medical subject headings: Nasal Polyps

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AZ compoundDrug
40 mg three times daily po for 12 weeks
Collection of Biological SpecimensOther
Also called Biomarkers
collection of biomarkers for analysis of nasal disease
Intranasal corticosteroidDrug
Also called Nasal Steroid (Nasonex, Flonase)
QD Nasal Spray
PlaceboDrug
looks like AZ compound, made by same company, double blind. 40 mg three times daily po for 12 weeks

Study groups in NCT02874144
Study group	Role	What they receive
AZ Compound	Experimental	40 mg 12 weeks TID po Receives: Drug: AZ compound; Other: Collection of Biological Specimens; Drug: Intranasal corticosteroid
Placebo	Placebo comparator	40 mg 12 weeks TID po Receives: Other: Collection of Biological Specimens; Drug: Intranasal corticosteroid; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: Baseline and Week 12

Secondary outcomes (2)

SNOT-22 (Sino-Nasal Outcome Test-22) Score
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.
Measured: Baseline and Week 12
Visual Analog Scale (VAS)
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.
Measured: Baseline and Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Jun 201610 Aug 2020

First posted22 Aug 2016 (estimated)
Study start20 Jun 2016
Primary completion7 Jan 2020
Study completion10 Aug 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Nasal PolypsStudies of the same condition, open and under way.
More trials run by Northwestern UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 43 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02874144
Sponsor's protocol ID: E1416 Sinus
Acronym: E1416
Status last verified: May 2022
First submitted: 26 Jul 2016
Last updated: 25 May 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

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.
PubMed 35524339

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingObservational study
Prospective, Non-interventional Single-arm Study With Tezepelumab to Investigate the Change in Clinical and Patient-reported Outcomes in Patients With CRSwNP in Real-world (PETRICHOR)
Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
Not yet recruiting
FESS With or Without Intranasal Desmopressin in Chronic Rhinosinusitis With Nasal Polyps
Chronic Sinusitis, Nasal Polyposis
Active, not recruitingPhase 3
A Phase 3 Study to Assess the Efficacy, Safety, and Tolerability of Itepekimab (Anti-IL-33 mAb) in Participants With Inadequately-controlled Chronic Rhinosinusitis With Nasal Polyps
Chronic Rhinosinusitis With Nasal Polyps
Active, not recruitingPhase 3
A Phase 3 Study to Assess the Efficacy, Safety, and Tolerability of Itepekimab (Anti-IL-33 mAb) in Participants With Inadequately-controlled Chronic Rhinosinusitis With Nasal Polyps
Chronic Rhinosinusitis With Nasal Polyps
RecruitingObservational study
Metabolic and Immunologic Biomarkers in Chronic Rhinosinusitis With Nasal Polyps
Chronic Rhinosinusitis With Nasal Polyps (CRSwNP), Nasal Polyps

All Nasal Polyps trials

Study at a glance

From the registry record, last updated by the sponsor on 25 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02874144
Acronym / sponsor ID: E1416 / E1416 Sinus
Conditions: Nasal Polyps
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 43 participants (actual)
Lead sponsor: Northwestern UniversityUniversity, hospital or other
Study start: 20 Jun 2016 (actual)
Primary completion: 7 Jan 2020 (actual)
Study completion: 10 Aug 2020 (actual)
First posted: 22 Aug 2016 (estimated)
Results: Posted 25 May 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
AZ Compound	Experimental	Drug: AZ compound, Other: Collection of Biological Specimens, Drug: Intranasal corticosteroid40 mg 12 weeks TID po
Placebo	Placebo comparator	Other: Collection of Biological Specimens, Drug: Intranasal corticosteroid, Drug: Placebo40 mg 12 weeks TID po

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

1. Females must have a negative urine pregnancy test at screening unless documented to have a hysterectomy or be postmenopausal.

Key exclusion criteria (3 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AZ compound40 mg three times daily po for 12 weeks	Drug	AZ Compound
Collection of Biological SpecimensAlso: Biomarkerscollection of biomarkers for analysis of nasal disease	Other	AZ Compound, Placebo
Intranasal corticosteroidAlso: Nasal Steroid (Nasonex, Flonase)QD Nasal Spray	Drug	AZ Compound, Placebo
Placebolooks like AZ compound, made by same company, double blind. 40 mg three times daily po for 12 weeks	Drug	Placebo

Primary outcome

TOTAL POLYP SCORE (TPS)
Time frame: 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.
Sinus CT Scan Scores by Lund-Mackay Scores
Time frame: 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.
BSIT (Brief Smell Identification Test)
Time frame: 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.

2 secondary outcomes

SNOT-22 (Sino-Nasal Outcome Test-22) Score
Time frame: Baseline and Week 12
Visual Analog Scale (VAS)
Time frame: Baseline and Week 12

Results and safety

Results posted to the registry on 25 May 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AZ Compound	22	19
Placebo	21	16

Primary outcome: TOTAL POLYP SCORE (TPS)

Time frame: Baseline and Week 12. Mean (Standard Error). Unit: units on a scale

Measure	AZD + INCS n = 22	PLACEBO + INCS n = 21
Value	4.67 (0.38)	5.24 (0.36)

AZD + INCS vs PLACEBO + INCS: Slope: 0, p <0.05, Regression, Linear
AZD + INCS vs PLACEBO + INCS: Mean Difference (Final Values): -20, p <0.05, repeated-measures linear regression

Population analysed: 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.

Primary outcome: Sinus CT Scan Scores by Lund-Mackay Scores

Time frame: Baseline and Week 12. Mean (Standard Error). Unit: units on a scale

Measure	AZD + INCS n = 22	PLACEBO + INCS n = 21
Visit 1 (Baseline)	17.44 (1.38)	15.53 (1.43)
Visit 5 (12 weeks)	18.25 (1.1)	16.33 (1.14)

Population analysed: 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.

Primary outcome: BSIT (Brief Smell Identification Test)

Time frame: Baseline and Week 12. Mean (Standard Error). Unit: units on a scale

Measure	AZD + INCS n = 22	PLACEBO + INCS n = 21
Visit 1 (Baseline)	5.75 (0.81)	5.20 (0.88)
Visit 5 (12 weeks)	6.92 (1.12)	5.80 (1.22)

Population analysed: 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.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Events were assessed every 2 weeks for the first month, then every 4 weeks for 12 weeks and during a 4 week washout period, an average of 5 months.. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AZ+INCS	1 of 22 (4.5%)	1 of 22 (4.5%)	0 of 22
Placebo + INCS	1 of 21 (4.8%)	0 of 21 (0%)	0 of 21

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35524339Price 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.
Individual participant dataSharing planned: No

Related trials for Nasal Polyps

RecruitingObservational study
Prospective, Non-interventional Single-arm Study With Tezepelumab to Investigate the Change in Clinical and Patient-reported Outcomes in Patients With CRSwNP in Real-world (PETRICHOR)
Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
Not yet recruiting
FESS With or Without Intranasal Desmopressin in Chronic Rhinosinusitis With Nasal Polyps
Chronic Sinusitis, Nasal Polyposis
Active, not recruitingPhase 3
A Phase 3 Study to Assess the Efficacy, Safety, and Tolerability of Itepekimab (Anti-IL-33 mAb) in Participants With Inadequately-controlled Chronic Rhinosinusitis With Nasal Polyps
Chronic Rhinosinusitis With Nasal Polyps
Active, not recruitingPhase 3
A Phase 3 Study to Assess the Efficacy, Safety, and Tolerability of Itepekimab (Anti-IL-33 mAb) in Participants With Inadequately-controlled Chronic Rhinosinusitis With Nasal Polyps
Chronic Rhinosinusitis With Nasal Polyps
RecruitingObservational study
Metabolic and Immunologic Biomarkers in Chronic Rhinosinusitis With Nasal Polyps
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Anju T Peters, MD principal investigator

Northwestern University

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AZ compound, Collection of Biological Specimens and Intranasal corticosteroid in people with Nasal Polyps, run by Northwestern University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 May 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 May 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

TOTAL POLYP SCORE (TPS) (time frame: Baseline and Week 12). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02874144, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2022; AzTrials last refreshed its copy on 27 Oct 2026.