Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To evaluate the efficacy of an anti-inflammatory agent compared with placebo in relieving signs and symptoms of disease in patients with sinusitis.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AZ Compound | Experimental | 40 mg 12 weeks TID po |
|
| Placebo | Placebo Comparator | 40 mg 12 weeks TID po |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZ compound | Drug | 40 mg three times daily po for 12 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
1. Females must have a negative urine pregnancy test at screening unless documented to have a hysterectomy or be postmenopausal.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Anju T Peters, MD | Northwestern University | Principal Investigator |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35524339 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | AZD + INCS | AZD1981 40 mg 3 times a day orally, added to 2 sprays daily of intranasal corticosteroid (INCS) spray for 12 weeks. |
| BG001 | PLACEBO + INCS | Placebo 3 times a day orally added to 2 sprays daily of intranasal corticosteroid (INCS) spray for 12 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Mean | Standard Error | units on a scale | Baseline and Week 12 |
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.
AE and SAE information was collected under GCP and specific IRB guidelines. All patients were assessed for adverse effects every 2 weeks for the first month and then every 4 weeks during the 12-week study and during a 4 week washout period by means of adverse events reports, physical examination, and laboratory tests (complete blood counts and renal and hepatic chemistries).
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AZ+INCS | AZD1981 40 mg three times a day , added to 2 sprays daily of intranasal corticosteroid (INCS) spray for 12 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diverticulitis | Gastrointestinal disorders | NU IRB, MedDRASOC | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rash | Respiratory, thoracic and mediastinal disorders | MedDra 17.0 | Systematic Assessment | One subject in the AZ group had a hypersensitivity reaction associated with a rash. This stopped with study drug. |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anju Peters | Northwestern | 3126950513 | anju.peters@northwestern.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 8, 2021 | Apr 8, 2021 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D009298 | Nasal Polyps |
| ID | Term |
|---|---|
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D011127 | Polyps |
Not provided
Not provided
| ID | Term |
|---|---|
| C000622345 | MeRho-Az compound |
| D015415 | Biomarkers |
| D000068656 | Mometasone Furoate |
| D000068298 | Fluticasone |
| ID | Term |
|---|---|
| D001685 | Biological Factors |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Collection of Biological Specimens |
| Other |
collection of biomarkers for analysis of nasal disease |
|
|
| Intranasal corticosteroid | Drug | QD Nasal Spray |
|
|
| Placebo | Drug | looks like AZ compound, made by same company, double blind. 40 mg three times daily po for 12 weeks |
|
| Baseline and Week 12 |
| 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. | Baseline and Week 12 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | AZD + INCS | AZD1981 40 mg three times a day , added to 2 sprays daily of intranasal corticosteroid (INCS) spray for 12 weeks. |
| OG001 | PLACEBO + INCS | Matched Placebo (1:1 randomization) three times a day added to 2 sprays daily of intranasal corticosteroid (INCS) spray for 12 weeks. |
|
|
|
| Primary | 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. | 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. | Posted | Mean | Standard Error | units on a scale | Baseline and Week 12 |
|
|
|
| Primary | 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. | 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. | Posted | Mean | Standard Error | units on a scale | Baseline and Week 12 |
|
|
|
| Secondary | 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. | 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. | Posted | Mean | Standard Error | units on a scale | Baseline and Week 12 |
|
|
|
| Secondary | 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. | 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. | Posted | Mean | Standard Error | units on a scale | Baseline and Week 12 |
|
|
|
| 0 |
| 22 |
| 1 |
| 22 |
| 1 |
| 22 |
| EG001 | Placebo + INCS | Matched Placebo (1:1 randomization) three times a day added to 2 sprays daily of intranasal corticosteroid (INCS) spray for 12 weeks | 0 | 21 | 1 | 21 | 0 | 21 |
| Hypersensitivity | Respiratory, thoracic and mediastinal disorders | NU IRB, MedDRASOC | Systematic Assessment | Blood and lymphatic system disorders |
|
|
Not provided
Not provided
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013256 |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |