Efficacy and Safety of Benralizumab in Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) With a History of Frequent Exacerbations

Chronic Obstructive Pulmonary Disease Clinical Trial

— RESOLUTE  

Official title:

A Multicenter, Randomized, Double-blind, Chronic-dosing, Parallel-group, Placebo-controlled Phase 3 Study to Evaluate the Efficacy and Safety of Benralizumab 100 mg in Patients With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) With a History of Frequent COPD Exacerbations and Elevated Peripheral Blood Eosinophils (RESOLUTE)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04053634
• Other study ID #: D3251C00014
• Secondary ID: 2019-001800-39
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: August 26, 2019
• Est. completion date: August 21, 2025

Study information

• Verified date: May 2024
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Phase 3 study to evaluate the efficacy and safety of a benralizumab in patients with moderate to very severe COPD with a history of frequent COPD exacerbations and elevated peripheral blood eosinophils (≥300/μL). Eligible patients must have a history of ≥2 moderate and/or severe COPD exacerbations in the previous year despite receiving triple (ICS/LABA/LAMA) background therapy for at least 3 months and ICS-based dual inhaled treatment for the remainder of the year. Eligible patients must also have an elevated blood eosinophil count. The treatment period will be of variable duration and will continue until the last patient has the opportunity to complete a minimum of 56 weeks, at which point all patients will complete the study. The primary endpoint will be analyzed at Week 56.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 645
• Est. completion date: August 21, 2025
• Est. primary completion date: August 21, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

Inclusion Criteria:

1. Provision of informed consent

2. Age 40 to 85 years

3. Male and/or female.

4. Current or former smoker with a tobacco history of =10 pack-years.

5. History of moderate to very severe COPD with a post-bronchodilator FEV1/FVC<0.70 and FEV1 =65% of predicted normal value.

6. Documented history of 2 or more COPD exacerbations that required treatment with systemic corticosteroids and/or hospitalization within 52 weeks prior to enrollment.

1. Exacerbations treated with antibiotics alone are excluded unless accompanied by treatment with systemic corticosteroids and/or hospitalization.

2. Hospitalization is defined as an inpatient admission =24 hours

3. Previous exacerbations should be confirmed to have occurred while on stable triple therapy for COPD.

4. At least one qualifying COPD exacerbation should occur while on stable uninterrupted triple therapy prior to enrolment.

7. Documented use of triple (ICS/LABA/LAMA) background therapy for COPD for =3 months immediately prior to enrollment.

1. Treatment with at least double inhaled therapy containing ICS (e.g. ICS/LABA or ICS/LAMA) for the remaining of 52 weeks prior to enrolment. Use of LABA/LAMA is allowed if ICS cannot be tolerated.

2. ICS in a dose approved for COPD or equivalent to =250 mcg of fluticasone propionate daily.

3. Total cumulative duration of not being on double or triple background therapy must not exceed 2 months.

4. Stable therapy/doses for the last 3 months prior to randomization.

8. Blood eosinophil count =300/µL at screening and documented historical eosinophil count of =150/µL within 52 weeks of enrollment (or repeated testing during run-in).

9. CAT total score =15 at Visit 1.

10. Negative pregnancy test for females of childbearing potential (WOCBP) at Visit 1.

11. Women of childbearing potential (WOCBP) must agree to use a highly effective method of birth control from enrollment throughout the study and within 12 weeks after last dose of IP. Women not of childbearing potential are defined as women who are either permanently sterilized or postmenopausal (confirmed by FSH test for women <50 years).

Exclusion Criteria:

1. Clinically important pulmonary disease other than COPD

2. Current diagnosis of asthma, prior history of asthma or asthma-COPD overlap according to GINA/GOLD. Childhood history of asthma is allowed and defined as asthma diagnosed and resolved before the age of 18.

3. Radiological findings of a respiratory disease other than COPD contributing to respiratory symptoms. Solitary pulmonary nodules without appropriate follow up or findings of acute infection.

4. Another pulmonary or systemic disease associated with elevated peripheral eosinophil counts.

5. Any unstable disorder that could affect patient safety, study findings or the patient's ability to complete the study.

6. Any clinically significant abnormal findings in physical examination, vital signs, ECG, laboratory tests could affect patient safety, study findings or the patient's ability to complete the study.

7. Cor pulmonale and/or right ventricular failure.

8. Long-term treatment with oxygen >4.0 L/min and/or oxyhemoglobin saturation <89% while breathing supplemental oxygen.

9. Use of any non-invasive positive pressure ventilation device (NIPPV). Note: use of CPAP for Sleep Apnea Syndrome is allowed.

10. Known immunodeficiency disorder, including positive HIV-1/2 testing.

11. Active liver disease. Chronic stable hepatitis B and C (including positive HBsAg or hepatitis C antibody testing), or other stable chronic liver disease are acceptable.

12. ALT or AST =3 times the upper limit of normal, confirmed by repeated testing during the run-in period.

13. Helminth parasitic infection within 24 weeks prior to enrollment, not treated or failed to respond to standard of care therapy.

14. Alcohol or drug abuse within the past year, which may compromise the study data.

15. Malignancy, current or within the past 5 years, except for adequately treated non invasive basal cell and squamous cell carcinoma of the skin and cervical carcinoma-in-situ treated with apparent success more than 1 year prior to Visit 1. Suspected malignancy or undefined neoplasms.

16. Evidence of active tuberculosis, as judged by investigator. Patients with a recent (within 2 years) first-time or newly positive PPD or Quantiferon test need to complete an appropriate course of treatment before enrollment. Evaluation will be according to the local standard of care.

17. Participation, or planned participation, in intensive COPD rehabilitation program (maintenance phase of a rehabilitation is allowed).

18. History of surgical or endoscopic lung volume reduction within the 6 months prior to enrollment. History of partial or total lung resection (single lobe or segmentectomy is acceptable).

19. Scheduled major surgical procedure during the study. Minor elective procedures are allowed.

20. History of anaphylaxis to any biologic therapy or vaccine.

21. Receipt of blood products or immunoglobulins within 30 days prior to randomization.

22. Receipt of marketed or investigational biologic product within 4 months or 5 half-lives prior to randomization, whichever is longer. Exception: Patients on stable therapy for 3 months before randomization who intend to stay on treatment throughout the study with marketed biologic products that are not likely to interfere with the safety assessment and/or efficacy of benralizumab, for example, for the treatment of osteoporosis, migraine, pain, diabetes, obesity, ocular, cardiovascular, or metabolic diseases, can participate in the study.

23. Receipt of live attenuated vaccines 30 days prior to randomization.

24. Chronic use of immunosuppressive medication or expected need for chronic use during the study.

25. Chronic use of antibiotics if duration of treatment is <9 months prior to randomization. Chronic macrolide or other antibiotic therapy is allowed provided the patient has been on stable dose/regimen for =9 months prior to randomization and has had =2 COPD exacerbations while on stable therapy.

26. Receipt of any investigational non-biologic product within 30 days or 5 half-lives prior to enrollment.

27. Receipt of benralizumab within 12 months prior to enrollment.

28. Known history of allergy or reaction to any component of the IP formulation.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Biological:
• Benralizumab
Benralizumab solution for injection in accessorized prefilled syringe (APFS) will be administered subcutaneously (SC) every 4 weeks for the first 3 doses - Weeks 0, 4 and 8, and then every 8 weeks until the end of treatment.
• Placebo
Matching placebo will be administered subcutaneously with accessorized prefilled syringe (APFS) every 4 weeks for the first 3 doses - Weeks 0, 4 and 8, and then every 8 weeks until the end of treatment.

Locations

Country	Name	City	State
Argentina	Research Site	Buenos Aires
Argentina	Research Site	Caba
Argentina	Research Site	Ciudad Autónoma de Buenos Aire
Argentina	Research Site	Ciudad de Buenos Aires
Argentina	Research Site	Córdoba
Argentina	Research Site	Florencio Varela
Argentina	Research Site	Florida
Argentina	Research Site	Mar del Plata
Argentina	Research Site	Mendoza
Argentina	Research Site	San Fernando
Argentina	Research Site	San Miguel de Tucuman
Australia	Research Site	Caringbah
Australia	Research Site	Melbourne
Australia	Research Site	South Brisbane
Australia	Research Site	Southport
Australia	Research Site	Spearwood
Austria	Research Site	Bad Ischl
Austria	Research Site	Bludenz
Austria	Research Site	Feldbach
Austria	Research Site	Grieskirchen
Austria	Research Site	Linz
Austria	Research Site	Thalheim
Belgium	Research Site	Edegem
Belgium	Research Site	Erpent
Brazil	Research Site	Blumenau
Brazil	Research Site	Botucatu
Brazil	Research Site	Florianópolis
Brazil	Research Site	Maringa
Brazil	Research Site	Porto Alegre
Brazil	Research Site	Porto Alegre
Brazil	Research Site	Porto Alegre
Brazil	Research Site	Porto Alegre
Brazil	Research Site	Santo Andre
Brazil	Research Site	Sao Bernardo do Campo
Brazil	Research Site	Sao Paulo
Brazil	Research Site	Sorocaba
Bulgaria	Research Site	Kozloduy
Bulgaria	Research Site	Ruse
Bulgaria	Research Site	Stara Zagora
Canada	Research Site	Ajax	Ontario
Canada	Research Site	Barrie	Ontario
Canada	Research Site	Calgary	Alberta
Canada	Research Site	Chicoutimi
Canada	Research Site	Montreal	Quebec
Canada	Research Site	Quebec
Canada	Research Site	Quebec
Canada	Research Site	Quebec
Canada	Research Site	Sarnia	Ontario
Canada	Research Site	Saskatoon	Saskatchewan
Canada	Research Site	St. John's	NF
Canada	Research Site	Stouffville	Ontario
Canada	Research Site	Toronto	Ontario
Canada	Research Site	Toronto	Ontario
Chile	Research Site	Curico
Chile	Research Site	Quillota
Chile	Research Site	Santiago
Chile	Research Site	Santiago
Chile	Research Site	Santiago
Chile	Research Site	Santiago
Chile	Research Site	Talca
China	Research Site	Baotou
China	Research Site	Beijing
China	Research Site	Beijing
China	Research Site	Changsha
China	Research Site	Changsha
China	Research Site	Changsha
China	Research Site	Chengdu
China	Research Site	Chongqing
China	Research Site	Ganzhou
China	Research Site	Guangzhou
China	Research Site	Guangzhou
China	Research Site	Guiyang
China	Research Site	Haikou
China	Research Site	Hebei
China	Research Site	Hefei
China	Research Site	Hohhot
China	Research Site	Hohhot
China	Research Site	Linhai
China	Research Site	Nanchang
China	Research Site	Shanghai
China	Research Site	Shanghai
China	Research Site	Shanghai
China	Research Site	Shenyang
China	Research Site	Shenzhen
China	Research Site	Suzhou
China	Research Site	Urumqi
China	Research Site	Wenzhou
China	Research Site	Wuhan
China	Research Site	Wuhan
China	Research Site	Xi'an
China	Research Site	Yinchuan
China	Research Site	Zhanjiang
China	Research Site	Zhengzhou
Colombia	Research Site	Barranquilla
Colombia	Research Site	Cali
Colombia	Research Site	Floridablanca
Colombia	Research Site	Medellin
Colombia	Research Site	Pereira
Colombia	Research Site	Zipaquira
Czechia	Research Site	Brandys nad Labem
Czechia	Research Site	Jindrichuv Hradec
Czechia	Research Site	Ostrava
Czechia	Research Site	Rokycany
Czechia	Research Site	Teplice
Denmark	Research Site	Ålborg
Denmark	Research Site	Hvidovre
Denmark	Research Site	København NV
Denmark	Research Site	Odense C
Denmark	Research Site	Roskilde
Denmark	Research Site	Vejle
Germany	Research Site	Bamberg
Germany	Research Site	Berlin
Germany	Research Site	Berlin
Germany	Research Site	Berlin
Germany	Research Site	Darmstadt
Germany	Research Site	Hamburg
Germany	Research Site	Hannover
Germany	Research Site	Koblenz
Germany	Research Site	Köln
Germany	Research Site	Leipzig
Germany	Research Site	Leipzig
Germany	Research Site	Leipzig
Germany	Research Site	Marburg
Germany	Research Site	Neu-Isenburg
Germany	Research Site	Peine
Germany	Research Site	Potsdam
Germany	Research Site	Rheine
Germany	Research Site	Warendorf
Greece	Research Site	Athens
Greece	Research Site	Exohi Thessaloniki
Greece	Research Site	Ioannina
Greece	Research Site	Thessaloniki
Greece	Research Site	Thessaloniki
Hungary	Research Site	Balassagyarmat
Hungary	Research Site	Budapest
Hungary	Research Site	Edelény
Hungary	Research Site	Encs
Hungary	Research Site	Gödöllo
Hungary	Research Site	Hajdúnánás
Hungary	Research Site	Komárom
Hungary	Research Site	Pécs
Hungary	Research Site	Siófok
Hungary	Research Site	Százhalombatta
Hungary	Research Site	Szeged
Hungary	Research Site	Törökbálint
India	Research Site	Calicut
India	Research Site	Chennai
India	Research Site	Coimbatore
India	Research Site	Guntur
India	Research Site	Hyderabad
India	Research Site	Jaipur
India	Research Site	Thane
India	Research Site	Vijayawada
Italy	Research Site	Cona
Italy	Research Site	Genova
Italy	Research Site	Milano
Italy	Research Site	Milano
Italy	Research Site	Napoli
Italy	Research Site	Reggio Emilia
Italy	Research Site	Roma
Italy	Research Site	Rozzano
Japan	Research Site	Chuo-ku
Japan	Research Site	Chuo-ku
Japan	Research Site	Fukuoka-shi
Japan	Research Site	Himeji-shi
Japan	Research Site	Hitachinaka-shi
Japan	Research Site	Joyo-shi
Japan	Research Site	Kawachinagano-shi
Japan	Research Site	Kishiwada-shi
Japan	Research Site	Kobe-shi
Japan	Research Site	Koto-ku
Japan	Research Site	Kure-shi
Japan	Research Site	Matsusaka-shi
Japan	Research Site	Mizunami-shi
Japan	Research Site	Nagaoka-shi
Japan	Research Site	Nagoya-shi
Japan	Research Site	Nishinomiya-shi
Japan	Research Site	Okayama-shi
Japan	Research Site	Osaka-shi
Japan	Research Site	Sagamihara-shi
Japan	Research Site	Sakai-shi
Japan	Research Site	Sakaide-shi
Japan	Research Site	Seto-shi
Japan	Research Site	Shinagawa-ku
Japan	Research Site	Shinagawa-ku
Japan	Research Site	Toshima-ku
Japan	Research Site	Toshima-ku
Japan	Research Site	Toshima-ku
Japan	Research Site	Toyonaka-shi
Japan	Research Site	Ueda-shi
Japan	Research Site	Yanagawa-shi
Japan	Research Site	Yokohama-shi
Korea, Republic of	Research Site	Daegu
Korea, Republic of	Research Site	Jeonju-si
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Wonju-si
Mexico	Research Site	Guadalajara
Mexico	Research Site	Guadalajara
Mexico	Research Site	Guadalajara
Mexico	Research Site	Mérida
Mexico	Research Site	Monterrey
Mexico	Research Site	Veracruz
Netherlands	Research Site	Breda
Netherlands	Research Site	Leeuwarden
New Zealand	Research Site	Auckland
New Zealand	Research Site	Auckland
New Zealand	Research Site	Christchurch
New Zealand	Research Site	Dunedin
New Zealand	Research Site	Hamilton
Philippines	Research Site	Iloilo City
Philippines	Research Site	Los Baños
Philippines	Research Site	Marilao
Philippines	Research Site	Quezon City
Poland	Research Site	Bialystok
Poland	Research Site	Checiny
Poland	Research Site	Grodzisk Mazowiecki
Poland	Research Site	Katowice
Poland	Research Site	Lódz
Poland	Research Site	Ostrowiec Swietokrzyski
Poland	Research Site	Poznan
Poland	Research Site	Poznan
Poland	Research Site	Proszowice
Poland	Research Site	Rzeszów
Poland	Research Site	Warszawa
Poland	Research Site	Wielun
Spain	Research Site	Barcelona
Spain	Research Site	Hospitalet de Llobregat(Barcel
Spain	Research Site	Laredo
Spain	Research Site	Madrid
Spain	Research Site	Madrid
Spain	Research Site	Madrid
Spain	Research Site	Málaga
Spain	Research Site	Santander
Sweden	Research Site	Go¨teborg
Sweden	Research Site	Göteborg
Sweden	Research Site	Lund
Sweden	Research Site	Malmö
Sweden	Research Site	Stockholm
Turkey	Research Site	Adana
Turkey	Research Site	Istanbul
Turkey	Research Site	Istanbul
Turkey	Research Site	Izmir
Turkey	Research Site	Kocaeli
Turkey	Research Site	Mersin
United Kingdom	Research Site	Barnsley
United Kingdom	Research Site	Birmingham
United Kingdom	Research Site	Blackpool
United Kingdom	Research Site	Bradford
United Kingdom	Research Site	Chertsey
United Kingdom	Research Site	Cottingham
United Kingdom	Research Site	Leicester
United Kingdom	Research Site	Manchester
United Kingdom	Research Site	Oxford
United Kingdom	Research Site	Perth
United Kingdom	Research Site	Southampton
United Kingdom	Research Site	Stockton-on-Tees
United Kingdom	Research Site	Wishaw
United States	Research Site	Abingdon	Virginia
United States	Research Site	Amarillo	Texas
United States	Research Site	Amarillo	Texas
United States	Research Site	Baltimore	Maryland
United States	Research Site	Boston	Massachusetts
United States	Research Site	Bronx	New York
United States	Research Site	Buffalo	New York
United States	Research Site	Burlington	North Carolina
United States	Research Site	Charlotte	North Carolina
United States	Research Site	Chattanooga	Tennessee
United States	Research Site	Chicago	Illinois
United States	Research Site	Clearwater	Florida
United States	Research Site	Cleveland	Ohio
United States	Research Site	Columbia	Maryland
United States	Research Site	Columbus	Ohio
United States	Research Site	Cudahy	Wisconsin
United States	Research Site	Cypress	Texas
United States	Research Site	Dallas	Texas
United States	Research Site	Daytona Beach	Florida
United States	Research Site	DuBois	Pennsylvania
United States	Research Site	Edgewater	Florida
United States	Research Site	Elizabeth City	North Carolina
United States	Research Site	Everett	Washington
United States	Research Site	Farmington Hills	Michigan
United States	Research Site	Fort Worth	Texas
United States	Research Site	Franklin	Tennessee
United States	Research Site	Gastonia	North Carolina
United States	Research Site	Georgetown	Kentucky
United States	Research Site	Hendersonville	Tennessee
United States	Research Site	Houston	Texas
United States	Research Site	Iowa City	Iowa
United States	Research Site	Jacksonville	Florida
United States	Research Site	Jacksonville	Florida
United States	Research Site	Johnson City	Tennessee
United States	Research Site	Kansas City	Kansas
United States	Research Site	Kerrville	Texas
United States	Research Site	Kissimmee	Florida
United States	Research Site	Kissimmee	Florida
United States	Research Site	Lawrenceville	Georgia
United States	Research Site	Leesburg	Florida
United States	Research Site	Lincoln	Nebraska
United States	Research Site	Little Rock	Arkansas
United States	Research Site	Los Angeles	California
United States	Research Site	Los Angeles	California
United States	Research Site	Medford	Oregon
United States	Research Site	Miami	Florida
United States	Research Site	Michigan City	Indiana
United States	Research Site	Mooresville	North Carolina
United States	Research Site	Morgantown	West Virginia
United States	Research Site	Mount Pleasant	South Carolina
United States	Research Site	New Bern	North Carolina
United States	Research Site	New Windsor	New York
United States	Research Site	Newport Beach	California
United States	Research Site	North Charleston	South Carolina
United States	Research Site	North Dartmouth	Massachusetts
United States	Research Site	Northridge	California
United States	Research Site	O'Fallon	Illinois
United States	Research Site	Oklahoma City	Oklahoma
United States	Research Site	Omaha	Nebraska
United States	Research Site	Orlando	Florida
United States	Research Site	Palm Springs	California
United States	Research Site	Pensacola	Florida
United States	Research Site	Peoria	Illinois
United States	Research Site	Philadelphia	Pennsylvania
United States	Research Site	Pittsburgh	Pennsylvania
United States	Research Site	Rapid City	South Dakota
United States	Research Site	Rincon	Georgia
United States	Research Site	Rock Hill	South Carolina
United States	Research Site	Saint Petersburg	Florida
United States	Research Site	Salem	Virginia
United States	Research Site	Salt Lake City	Utah
United States	Research Site	San Antonio	Texas
United States	Research Site	Smithfield	Pennsylvania
United States	Research Site	Spokane	Washington
United States	Research Site	Stamford	Connecticut
United States	Research Site	Surprise	Arizona
United States	Research Site	Tampa	Florida
United States	Research Site	Tomball	Texas
United States	Research Site	Toms River	New Jersey
United States	Research Site	Westminster	California
United States	Research Site	Williamsburg	Virginia
United States	Research Site	Wilmington	North Carolina
United States	Research Site	Winston-Salem	North Carolina
United States	Research Site	Winter Park	Florida
Vietnam	Research Site	Hanoi
Vietnam	Research Site	Ho Chi Minh
Vietnam	Research Site	Ho Chi Minh city

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Vietnam,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Bulgaria,  Canada,  Chile,  China,  Colombia,  Czechia,  Denmark,  Germany,  Greece,  Hungary,  India,  Italy,  Japan,  Korea, Republic of,  Mexico,  Netherlands,  New Zealand,  Philippines,  Poland,  Spain,  Sweden,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety and tolerability of benralizumab in patients with moderate to very severe COPD	AEs, vital signs, clinical laboratory, and ECG	Minimum of 1 year and average of 2 years
Primary	Annualized rate of moderate or severe COPD exacerbations	Moderate or severe COPD exacerbation is defined by symptomatic worsening of COPD requiring: Use of systemic corticosteroids for at least 3 days; and/or; Use of antibiotics; and/or; An inpatient hospitalization or death due to COPD	Over first 56 weeks
Secondary	Annualized rate of severe COPD exacerbations	A severe COPD exacerbation is defined by symptomatic worsening of COPD requiring an inpatient hospitalization or results in death due to COPD	Minimum of 1 year and an average of 2 years
Secondary	Annualized rate of COPD exacerbations that are associated with an emergency room/emergency department visit or a hospitalization		Minimum of 1 year and an average of 2 years
Secondary	Time to first COPD exacerbation		During first 56 weeks
Secondary	Change from baseline in SGRQ total and domain scores	St. George's Respiratory Questionnaire (SGRQ)	up to 56 weeks
Secondary	Change from baseline in E-RS:COPD total and domain scores	Evaluating Respiratory Symptoms in COPD (E-RS:COPD)	up to 56 weeks
Secondary	Change from baseline in pre-dose/pre-bronchodilator FEV1	FEV1 is the Forced expiratory volume in one second at study site	up to 56 weeks
Secondary	All cause and respiratory-related mortality rate		Minimum of 1 year and an average of 2 years
Secondary	Annual rate of hospitalizations due to COPD		Minimum of 1 year and an average of 2 years
Secondary	Serum benralizumab concentration as a measure of pharmacokinetics		up to 56 weeks
Secondary	Anti-drug antibodies (ADA) as a measure of immunogenicity		up to 56 weeks
Secondary	Change from baseline in CAT total score	Chronic Obstructive Pulmonary Disease assessment tool (CAT)	up to 56 weeks
Secondary	Length of hospital stay		Minimum of 1 year and an average of 2 years
Secondary	ICU (Intensive Care Unit) days		Minimum of 1 year and an average of 2 years
Secondary	Annual rate of hospitalizations and emergency department visits combined		Minimum of 1 year and an average of 2 years
Secondary	Annual rate of unscheduled outpatient visits including unscheduled visits to study sites		Minimum of 1 year and an average of 2 years
Secondary	Annual rate of unscheduled healthcare encounters		Minimum of 1 year and and average of 2 years

External Links

•   This is a poster on the Resolute study.