Study to Assess PT010 in Adult and Adolescent Participants With Inadequately Controlled Asthma (KALOS)

Asthma Clinical Trial

— KALOS  

Official title:

A Randomized, Double-Blind, Double Dummy, Parallel Group, Multicenter Variable Length Study to Assess the Efficacy and Safety of PT010 Relative to PT009 and Symbicort® in Adult and Adolescent Participants With Inadequately Controlled Asthma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04609878
• Other study ID #: D5982C00007
• Secondary ID: 2023-505787-1120
• Status: Recruiting
• Phase: Phase 3
• Start date: December 15, 2020
• Est. completion date: March 21, 2025

Study information

• Verified date: June 2024
• Source: AstraZeneca
• Contact: AstraZeneca Clinical Study Information Center
• Phone: 1-877-240-9479
• Email: information.center[@]astrazeneca.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a variable length study to evaluate the efficacy and safety of budesonide/glycopyrronium/formoterol inhaler in adults and adolescents with severe asthma inadequately controlled with standard of care

Description:

This is a randomized, double-blind, double dummy, parallel group, multicenter 24 to 52 week variable length study to assess the efficacy and safety of budesonide, glycopyrronium, and formoterol fumarate metered dose inhaler (MDI) relative to budesonide and formoterol fumarate MDI and Symbicort® pressurized MDI in adult and adolescent participants with inadequately controlled asthma. Approximately 2200 participants will be randomized globally.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2200
• Est. completion date: March 21, 2025
• Est. primary completion date: March 21, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 80 Years

Eligibility

Inclusion Criteria:

1. 12 to 80 years of age, male and female, BMI <40 kg/m2; females must be not of childbearing potential or using a form of highly effective birth control.

2. Documented history of physician-diagnosed asthma > and/or = 1 year prior to V1.

3. Regularly using a stable daily ICS/LABA regimen (including a stable ICS dose) with medium-to-high ICS doses for at least 4 weeks prior to V1.

4. ACQ-7 total score =1.5 at Visits 1, 3, and 5 (pre-randomization).

5. FEV1 % (assessed as an average of the 60 and 30 minute pre-dose assessments) predicted normal at V1, 2, 3, 4, and 5 (pre-randomization)

• Participants = 18 years of age: < 80%
• Participants 12 to <18 years of age: < 90%

6. FEV1 post-albuterol at V2 or V3 (if repeat needed).

• Participants > and/or = 18 years of age: Increase > and/or = 12% and > and/or = 200 mL.
• Participants 12 to <18 years of age: Increase =12% either in the 12 months prior to Visit 1 or at Visit 2, or at Visit 3.
• Note: Even if there is documented history of reversibility, all participants must be assessed for reversibility at Visit 2 (and Visit 3, if reversibility is not demonstrated at Visit 2) to provide reversibility baseline data for characterization.

7. Willing and, in the opinion of the Investigator, able to adjust current asthma therapy, as required by the protocol.

8. Demonstrate acceptable MDI/pMDI administration technique.

9. Received no asthma medication other than run-in BFF MDI BID and albuterol as needed during screening (except for allowed medications as defined in Table 9 and systemic corticosteroid or ICS for the treatment of an asthma exacerbation).

10. eDiary 14-day compliance =70% during screening (defined as completing the daily eDiary for any 10 mornings and any 10 evenings and answering "Yes" to taking 2 puffs of run-in BFF MDI for any 10 mornings and 10 evenings in the last 14 days prior to randomization).

11. No respiratory infection in the 4 weeks prior to randomization, or asthma exacerbation treated with systemic corticosteroid and/or additional ICS treatment in the 4 weeks prior to randomization.

Exclusion Criteria:

1. Completed treatment for respiratory infection or asthma exacerbation with systemic corticosteroids within 4 weeks of V1. 2a. Participants where, in the opinion of the Investigator, treatment with biological therapy for asthma would be appropriate. 2b. Any marketed or investigational biologics within 3 months or 5 half-lives of V1, whichever is longer and must not be used during study duration.

3. Current smokers, former smokers with >10 pack-years history, or former smokers who stopped smoking <6 months prior to V1 (including all forms of tobacco, e-cigarettes or other vaping devices, and marijuana).

4. Current evidence of Chronic Obstructive Pulmonary Disease (COPD). 5a. Oral and IV corticosteroid use (any dose) within 4 weeks of V1. 5b. Use of systemic corticosteroids for any other reason except for the acute treatment of severe asthma exacerbation is prohibited for the duration of the study. 5c. Depot corticosteroid use for any reason within 3 months of V1.

6. Use of Long-Acting Muscarinic Antagonist (LAMA), either alone or as part of an inhaled combination therapy, in the 12 weeks prior to V1.

7. Use of oral beta2-agonist within 3 months of V1.

8. Use of any immunomodulators or immunosuppressive medication within 3 months or 5 half-lives, whichever is longer, and must not be used during the study duration.

9. Narrow angle glaucoma not adequately treated and/or change in vision that may be relevant, in the opinion of the Investigator, within 3 months of Visit 1.

10. Life-threatening asthma defined as a history of significant asthma episode(s) requiring intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma-related syncopal episode(s).

11. Hospitalization for asthma within 2 months of Visit 1.

12. Known history of drug or alcohol abuse within 12 months of Visit 1.

13. Regular use of a nebulizer or a home nebulizer for receiving asthma medications.

14. Using any herbal products by inhalation or nebulizer within 4 weeks of Visit 1 and does not agree to stop during the study duration.

15. Participation in another clinical study with a study intervention administered in the last 30 days or 5 half-lives, whichever is longer. Any other study intervention that is not identified in the protocol is prohibited for use during study duration.

16. Participants with a known hypersensitivity to beta2-agonists, corticosteroids, anticholinergics, or any component of the MDI or pMDI.

17. Study Investigators, sub-Investigators, coordinators, and their employees or immediate family members.

18. For women only - currently pregnant (confirmed with positive highly sensitive pregnancy test), breast-feeding, or planned pregnancy during the study or not using acceptable contraception measures, as judged by the Investigator. Please refer to the study protocol for the complete inclusion and exclusion criteria list.

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• BGF MDI 320/28.8/9.6 µg
Budesonide, glycopyrronium, and formoterol fumarate metered dose inhaler
• BGF MDI 320/14.4/9.6 µg
Budesonide, glycopyrronium, and formoterol fumarate metered dose inhaler
• BFF MDI 320/9.6 µg
Budesonide and formoterol fumarate metered dose inhaler
• BFF pMDI 320/9 µg
Budesonide/formoterol fumarate pressurized metered dose inhaler

Locations

Country	Name	City	State
Argentina	Research Site	Buenos Aires
Argentina	Research Site	Buenos Aires
Argentina	Research Site	Buenos Aires
Argentina	Research Site	Caba
Argentina	Research Site	Caba
Argentina	Research Site	Caba
Argentina	Research Site	Ciudad Autonoma de Buenos Aire
Argentina	Research Site	Ciudad de Buenos Aires
Argentina	Research Site	Córdoba
Argentina	Research Site	Florida
Argentina	Research Site	Mar del Plata
Argentina	Research Site	Mendoza
Argentina	Research Site	Ranelagh
Argentina	Research Site	Rosario
Argentina	Research Site	Rosario
Argentina	Research Site	San Fernando
Australia	Research Site	Darlinghurst
Australia	Research Site	Melbourne
Australia	Research Site	South Brisbane
Australia	Research Site	Spearwood
Belgium	Research Site	Bruxelles
Belgium	Research Site	Edegem
Belgium	Research Site	Liège
Belgium	Research Site	Namur
Belgium	Research Site	Roeselare
Bulgaria	Research Site	Dupnitsa
Bulgaria	Research Site	Dupnitsa
Bulgaria	Research Site	Haskovo
Bulgaria	Research Site	Kozloduy
Bulgaria	Research Site	Lovech
Bulgaria	Research Site	Pazardzhik
Bulgaria	Research Site	Petrich
Bulgaria	Research Site	Pleven
Bulgaria	Research Site	Pleven
Bulgaria	Research Site	Ruse
Bulgaria	Research Site	Ruse
Bulgaria	Research Site	Sevlievo
Bulgaria	Research Site	Sliven
Bulgaria	Research Site	Smolyan
Bulgaria	Research Site	Sofia
Bulgaria	Research Site	Sofia
Bulgaria	Research Site	Sofia
Bulgaria	Research Site	Sofia
Bulgaria	Research Site	Sofia
Bulgaria	Research Site	Stara Zagora
Bulgaria	Research Site	Stara Zagora
Bulgaria	Research Site	Varna
Bulgaria	Research Site	Veliko Tarnovo
Bulgaria	Research Site	Vidin
Bulgaria	Research Site	Vratsa
Canada	Research Site	Ajax	Ontario
Canada	Research Site	Burlington	Ontario
Canada	Research Site	Calgary	Alberta
Canada	Research Site	Edmonton	Alberta
Canada	Research Site	Edmonton	Alberta
Canada	Research Site	Hamilton	Ontario
Canada	Research Site	Kelowna	British Columbia
Canada	Research Site	London	Ontario
Canada	Research Site	Lower Sackville	Nova Scotia
Canada	Research Site	Mount Pearl	Newfoundland and Labrador
Canada	Research Site	Newmarket	Ontario
Canada	Research Site	Niagara Falls	Ontario
Canada	Research Site	Niagara Falls	Ontario
Canada	Research Site	Quebec
Canada	Research Site	Quebec
Canada	Research Site	Quebec
Canada	Research Site	Sherwood Park	Alberta
Canada	Research Site	Toronto	Ontario
Canada	Research Site	Toronto	Ontario
Canada	Research Site	Toronto	Ontario
Canada	Research Site	Vancouver	British Columbia
Canada	Research Site	Vancouver	British Columbia
Canada	Research Site	Winnipeg	Manitoba
Canada	Research Site	Winnipeg	Manitoba
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	Santiago
Chile	Research Site	Talca
Chile	Research Site	Temuco
Chile	Research Site	Viña del Mar
Chile	Research Site	Viña del Mar
Denmark	Research Site	Aalborg
Denmark	Research Site	Hjørring
Denmark	Research Site	Hvidovre
Denmark	Research Site	Vejle
Hungary	Research Site	Balassagyarmat
Hungary	Research Site	Budapest
Hungary	Research Site	Budapest
Hungary	Research Site	Edelény
Hungary	Research Site	Encs
Hungary	Research Site	Farkasgyepü
Hungary	Research Site	Gödöllo
Hungary	Research Site	Hajdúnánás
Hungary	Research Site	Hódmezovásárhely
Hungary	Research Site	Komárom
Hungary	Research Site	Pécs
Hungary	Research Site	Siófok
Hungary	Research Site	Szeged
Hungary	Research Site	Szeged
Hungary	Research Site	Szigetvár
India	Research Site	Ahmedabad
India	Research Site	Aligarh
India	Research Site	Bangalore
India	Research Site	Belagavi
India	Research Site	Bengaluru
India	Research Site	Coimbatore
India	Research Site	Dehradun
India	Research Site	Gurgaon
India	Research Site	Hyderabad
India	Research Site	Jaipur
India	Research Site	Jaipur
India	Research Site	Mohali
India	Research Site	Mumbai
India	Research Site	Nagpur
India	Research Site	New Delhi
India	Research Site	New Delhi
India	Research Site	New Delhi
India	Research Site	Noida
India	Research Site	Thane
India	Research Site	Vishakhapatnam
Italy	Research Site	Bari
Italy	Research Site	Battipaglia
Italy	Research Site	Biancavilla
Italy	Research Site	Casatenovo
Italy	Research Site	Catanzaro
Italy	Research Site	Cona
Italy	Research Site	Firenze
Italy	Research Site	Garbagnate Milanese
Italy	Research Site	Milano
Italy	Research Site	Monserrato
Italy	Research Site	Napoli
Italy	Research Site	Napoli
Italy	Research Site	Pisa
Italy	Research Site	Roma
Italy	Research Site	Roma
Italy	Research Site	Salerno
Italy	Research Site	Sassari
Japan	Research Site	Chino-shi
Japan	Research Site	Chuo-ku
Japan	Research Site	Chuo-ku
Japan	Research Site	Chuo-ku
Japan	Research Site	Chuo-ku
Japan	Research Site	Fukui-shi
Japan	Research Site	Fukuoka-shi
Japan	Research Site	Fukuoka-shi
Japan	Research Site	Fukuoka-shi
Japan	Research Site	Habikino-shi
Japan	Research Site	Hamamatsu-shi
Japan	Research Site	Higashiibaraki-gun
Japan	Research Site	Himeji-shi
Japan	Research Site	Hiroshima-shi, Naka-ku
Japan	Research Site	Hitachinaka-shi
Japan	Research Site	Ikoma-shi
Japan	Research Site	Kagoshima-shi
Japan	Research Site	Kanazawa-shi
Japan	Research Site	Kishiwada-shi
Japan	Research Site	Kitakyusyu
Japan	Research Site	Kiyose-shi
Japan	Research Site	Kokubunji-shi
Japan	Research Site	Kyoto-shi
Japan	Research Site	Kyoto-shi
Japan	Research Site	Meguro-ku
Japan	Research Site	Miyazaki-shi
Japan	Research Site	Nagaoka-shi
Japan	Research Site	Nagoya-shi
Japan	Research Site	Nankoku-shi
Japan	Research Site	Obihiro
Japan	Research Site	Oita-shi
Japan	Research Site	Omuta-shi
Japan	Research Site	Osaka-shi
Japan	Research Site	Osaka-shi
Japan	Research Site	Osaka-shi
Japan	Research Site	Saga-shi
Japan	Research Site	Sakaide-shi
Japan	Research Site	Sapporo-shi
Japan	Research Site	Sapporo-shi
Japan	Research Site	Setagaya-ku
Japan	Research Site	Setagaya-ku
Japan	Research Site	Shibuya-ku
Japan	Research Site	Shimotsuga-gun
Japan	Research Site	Shinagawa-ku
Japan	Research Site	Shinagawa-ku
Japan	Research Site	Shinjuku-ku
Japan	Research Site	Shinjuku-ku
Japan	Research Site	Shizuoka
Japan	Research Site	Takarazuka-shi
Japan	Research Site	Tanabe-shi
Japan	Research Site	Toon-shi
Japan	Research Site	Toshima-ku
Japan	Research Site	Toshima-ku
Japan	Research Site	Toshima-ku
Japan	Research Site	Toyama-shi
Japan	Research Site	Tsuchiura-shi
Japan	Research Site	Utsunomiya-shi
Japan	Research Site	Yanagawa-shi
Japan	Research Site	Yokohama-shi
Japan	Research Site	Yokohama-shi
Japan	Research Site	Yokohama-shi
Japan	Research Site	Yokohama-shi
Japan	Research Site	Yokohama-shi
Korea, Republic of	Research Site	Cheongju-si
Korea, Republic of	Research Site	Gangwon-do
Korea, Republic of	Research Site	Jeonju-si
Korea, Republic of	Research Site	Seongnam-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	Seoul
Korea, Republic of	Research Site	Suwon-si
Korea, Republic of	Research Site	Uijeongbu
Korea, Republic of	Research Site	Ulsan
Netherlands	Research Site	Deventer
Netherlands	Research Site	Eindhoven
Netherlands	Research Site	Heerlen
Netherlands	Research Site	Nijmegen
Netherlands	Research Site	Zutphen
New Zealand	Research Site	Auckland
New Zealand	Research Site	Auckland
New Zealand	Research Site	Grafton
New Zealand	Research Site	Nawton
New Zealand	Research Site	Nelson
New Zealand	Research Site	Rotorua
New Zealand	Research Site	Wellington
Peru	Research Site	Cusco
Peru	Research Site	Lima
Peru	Research Site	Lima
Peru	Research Site	Lima
Peru	Research Site	Lima
Peru	Research Site	Lima
Peru	Research Site	Lima
Peru	Research Site	Lima
Peru	Research Site	Piura
Philippines	Research Site	Baguio
Philippines	Research Site	Baguio City
Philippines	Research Site	Caloocan City
Philippines	Research Site	Davao City
Philippines	Research Site	Davao City
Philippines	Research Site	Iloilo City
Philippines	Research Site	Iloilo City
Philippines	Research Site	Las Pinas
Philippines	Research Site	Lipa City
Philippines	Research Site	Los Baños
Philippines	Research Site	Manila
Philippines	Research Site	Manila
Philippines	Research Site	Marilao
Philippines	Research Site	Pasig City
Philippines	Research Site	Quezon City
Philippines	Research Site	Quezon City
Philippines	Research Site	Quezon City
Poland	Research Site	Bialystok
Poland	Research Site	Bialystok
Poland	Research Site	Bydgoszcz
Poland	Research Site	Czestochowa
Poland	Research Site	Karczew
Poland	Research Site	Katowice
Poland	Research Site	Kielce
Poland	Research Site	Krakow
Poland	Research Site	Kraków
Poland	Research Site	Kraków
Poland	Research Site	Lublin
Poland	Research Site	Piaseczno
Poland	Research Site	Poznan
Poland	Research Site	Poznan
Poland	Research Site	Poznan
Poland	Research Site	Poznan
Poland	Research Site	Poznan
Poland	Research Site	Poznan
Poland	Research Site	Rzeszow
Poland	Research Site	Rzeszów
Poland	Research Site	Rzeszów
Poland	Research Site	Sosnowiec
Poland	Research Site	Sosnowiec
Poland	Research Site	Strzelce Opolskie
Poland	Research Site	Szczecin
Poland	Research Site	Tarnów
Poland	Research Site	Wroclaw
Poland	Research Site	Wroclaw
Puerto Rico	Research Site	Caguas
Puerto Rico	Research Site	Guaynabo
Puerto Rico	Research Site	Ponce
Puerto Rico	Research Site	San Juan
Romania	Research Site	Bra?ov
Romania	Research Site	Brasov
Romania	Research Site	Brasov
Romania	Research Site	Bucharest
Romania	Research Site	Bucharest
Romania	Research Site	Ia?i
Romania	Research Site	Timisoara
Spain	Research Site	Barcelona
Spain	Research Site	Benalmádena
Spain	Research Site	Coslada
Spain	Research Site	Girona
Spain	Research Site	L'Hospitalet de Llobregat
Spain	Research Site	Madrid
Spain	Research Site	Madrid
Spain	Research Site	Málaga
Spain	Research Site	Marbella (Málaga)
Spain	Research Site	Pozuelo de Alarcón
Spain	Research Site	Santander
Spain	Research Site	Santiago De Compostela-Coruña
Spain	Research Site	Valencia
Spain	Research Site	Zaragoza
Spain	Research Site	Zaragoza
Taiwan	Research Site	Changhua
Taiwan	Research Site	Kaohsiung
Taiwan	Research Site	Kaohsiung
Taiwan	Research Site	Kaohsiung City
Taiwan	Research Site	New Taipei
Taiwan	Research Site	Taichung
Taiwan	Research Site	Taichung
Taiwan	Research Site	Tainan
Taiwan	Research Site	Taipei
Taiwan	Research Site	Taipei
Taiwan	Research Site	Taipei City
Taiwan	Research Site	Tao-Yuan
Thailand	Research Site	Bang Kra So
Thailand	Research Site	Bangkok
Thailand	Research Site	Bangkok
Thailand	Research Site	Bangkok
Thailand	Research Site	Hat Yai
Thailand	Research Site	Hatyai
Thailand	Research Site	Khon Kaen
Thailand	Research Site	Mae Rim
Thailand	Research Site	Muang
Thailand	Research Site	Muang
Thailand	Research Site	Mueang
Thailand	Research Site	Mueang Chanthaburi
United States	Research Site	Adairsville	Georgia
United States	Research Site	Albuquerque	New Mexico
United States	Research Site	Albuquerque	New Mexico
United States	Research Site	Amarillo	Texas
United States	Research Site	Anderson	South Carolina
United States	Research Site	Atlanta	Georgia
United States	Research Site	Austin	Texas
United States	Research Site	Bangor	Maine
United States	Research Site	Baytown	Texas
United States	Research Site	Beaumont	Texas
United States	Research Site	Bellevue	Nebraska
United States	Research Site	Birmingham	Alabama
United States	Research Site	Boerne	Texas
United States	Research Site	Boston	Massachusetts
United States	Research Site	Brandon	Florida
United States	Research Site	Brick	New Jersey
United States	Research Site	Bronx	New York
United States	Research Site	Bronx	New York
United States	Research Site	Brownsburg	Indiana
United States	Research Site	Burlington	Vermont
United States	Research Site	Champaign	Illinois
United States	Research Site	Charlotte	North Carolina
United States	Research Site	Charlotte	North Carolina
United States	Research Site	Chesterfield	Missouri
United States	Research Site	Chicago	Illinois
United States	Research Site	Chicago	Illinois
United States	Research Site	Chicago	Illinois
United States	Research Site	Cincinnati	Ohio
United States	Research Site	Cincinnati	Ohio
United States	Research Site	Clarksville	Tennessee
United States	Research Site	Clinton	South Carolina
United States	Research Site	Colorado Springs	Colorado
United States	Research Site	Columbia	Maryland
United States	Research Site	Columbus	Georgia
United States	Research Site	Covina	California
United States	Research Site	Crowley	Louisiana
United States	Research Site	Cudahy	Wisconsin
United States	Research Site	Cypress	Texas
United States	Research Site	Dallas	Texas
United States	Research Site	Denver	North Carolina
United States	Research Site	DuBois	Pennsylvania
United States	Research Site	Duluth	Georgia
United States	Research Site	East Providence	Rhode Island
United States	Research Site	Edmond	Oklahoma
United States	Research Site	El Paso	Texas
United States	Research Site	Encinitas	California
United States	Research Site	Fargo	North Dakota
United States	Research Site	Flint	Michigan
United States	Research Site	Franklin	Tennessee
United States	Research Site	Fresno	California
United States	Research Site	Gastonia	North Carolina
United States	Research Site	Georgetown	Texas
United States	Research Site	Georgetown	Kentucky
United States	Research Site	Grants Pass	Oregon
United States	Research Site	Greenville	South Carolina
United States	Research Site	Hampton	Georgia
United States	Research Site	Hannibal	Missouri
United States	Research Site	Harlingen	Texas
United States	Research Site	Houston	Texas
United States	Research Site	Houston	Texas
United States	Research Site	Houston	Texas
United States	Research Site	Huntsville	Alabama
United States	Research Site	Indianapolis	Indiana
United States	Research Site	Kerrville	Texas
United States	Research Site	Kingwood	West Virginia
United States	Research Site	Lafayette	Louisiana
United States	Research Site	Laguna Hills	California
United States	Research Site	Lake Charles	Louisiana
United States	Research Site	Lakewood	Colorado
United States	Research Site	Lampasas	Texas
United States	Research Site	Las Vegas	Nevada
United States	Research Site	Lawrenceville	Georgia
United States	Research Site	Lincoln	Nebraska
United States	Research Site	Little Rock	Arkansas
United States	Research Site	Long Beach	California
United States	Research Site	Los Angeles	California
United States	Research Site	Los Angeles	California
United States	Research Site	Louisville	Kentucky
United States	Research Site	Manassas	Virginia
United States	Research Site	Maumee	Ohio
United States	Research Site	Medford	Oregon
United States	Research Site	Mesquite	Texas
United States	Research Site	Miami	Florida
United States	Research Site	Mission Hills	California
United States	Research Site	Missoula	Montana
United States	Research Site	Mooresville	North Carolina
United States	Research Site	Morgantown	West Virginia
United States	Research Site	New Hyde Park	New York
United States	Research Site	New Windsor	New York
United States	Research Site	New York	New York
United States	Research Site	New York	New York
United States	Research Site	Newport Beach	California
United States	Research Site	Newport News	Virginia
United States	Research Site	North Charleston	South Carolina
United States	Research Site	Northridge	California
United States	Research Site	Ocala	Florida
United States	Research Site	Ogden	Utah
United States	Research Site	Oklahoma City	Oklahoma
United States	Research Site	Orangeburg	South Carolina
United States	Research Site	Palm Harbor	Florida
United States	Research Site	Pearland	Texas
United States	Research Site	Phoenix	Arizona
United States	Research Site	Phoenix	Arizona
United States	Research Site	Pittsburgh	Pennsylvania
United States	Research Site	Pittsburgh	Pennsylvania
United States	Research Site	Plano	Texas
United States	Research Site	Potomac	Maryland
United States	Research Site	Raleigh	North Carolina
United States	Research Site	Reading	Pennsylvania
United States	Research Site	Red Oak	Texas
United States	Research Site	Rincon	Georgia
United States	Research Site	River Forest	Illinois
United States	Research Site	Saint Louis	Missouri
United States	Research Site	Saint Louis	Missouri
United States	Research Site	Saint Petersburg	Florida
United States	Research Site	San Antonio	Texas
United States	Research Site	San Antonio	Texas
United States	Research Site	San Antonio	Texas
United States	Research Site	San Diego	California
United States	Research Site	Saraland	Alabama
United States	Research Site	Savannah	Georgia
United States	Research Site	Scottdale	Pennsylvania
United States	Research Site	Scottsdale	Arizona
United States	Research Site	Smithfield	Pennsylvania
United States	Research Site	Staten Island	New York
United States	Research Site	Stockbridge	Georgia
United States	Research Site	Stockton	California
United States	Research Site	Sugar Land	Texas
United States	Research Site	Sun City West	Arizona
United States	Research Site	Tallahassee	Florida
United States	Research Site	Tampa	Florida
United States	Research Site	Thousand Oaks	California
United States	Research Site	Toledo	Ohio
United States	Research Site	Tomball	Texas
United States	Research Site	Tomball	Texas
United States	Research Site	Toms River	New Jersey
United States	Research Site	Tucson	Arizona
United States	Research Site	Tucson	Arizona
United States	Research Site	Tulsa	Oklahoma
United States	Research Site	Tulsa	Oklahoma
United States	Research Site	Tyrone	Georgia
United States	Research Site	Upland	California
United States	Research Site	Valdosta	Georgia
United States	Research Site	Waldorf	Maryland
United States	Research Site	Waterbury	Connecticut
United States	Research Site	West Des Moines	Iowa
United States	Research Site	West Valley City	Utah
United States	Research Site	Westminster	California
United States	Research Site	Winter Garden	Florida
Vietnam	Research Site	Ha Noi
Vietnam	Research Site	Hanoi
Vietnam	Research Site	Ho Chi Minh
Vietnam	Research Site	Ho Chi Minh
Vietnam	Research Site	Ho Chi Minh
Vietnam	Research Site	Ho Chi Minh City
Vietnam	Research Site	Hochiminh

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Vietnam,  Argentina,  Australia,  Belgium,  Bulgaria,  Canada,  Chile,  Denmark,  Hungary,  India,  Italy,  Japan,  Korea, Republic of,  Netherlands,  New Zealand,  Peru,  Philippines,  Poland,  Puerto Rico,  Romania,  Spain,  Taiwan,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in forced expiratory volume in 1 second (FEV1) area under the curve 0 to 3 hours (AUC0-3) at Week 24	Change from baseline in forced expiratory volume in 1 second (FEV1) area under the curve 0 to 3 hours (AUC0-3) at Week 24	24 Weeks
Primary	Rate of severe asthma exacerbations	Primary end point(s) of Pooled Studies D5982C00007 and D5982C00008: Rate of severe asthma exacerbations	Up to 52 weeks
Secondary	Change from baseline in morning pre-dose trough FEV1 at Week 24	Change from baseline in morning pre-dose trough FEV1 at Week 24	24 Weeks
Secondary	Percentage of responders in Asthma Control Questionnaire (ACQ)-7 (=0.5 decrease equals response) at Week 24	Percentage of responders in ACQ-7 (=0.5 decrease equals response) at Week 24. Additional analysis will be conducted using pooled data from studies D5982C00007 and D5982C00008	24 weeks
Secondary	Percentage of responders in ACQ-5 (=0.5 decrease equals response) at Week 24	Percentage of responders in ACQ-5 (=0.5 decrease equals response) at Week 24. Additional analysis will be conducted using pooled data from studies D5982C00007 and D5982C00008	24 Weeks
Secondary	Percentage of responders in the Asthma Quality of Life Questionnaire for 12 years and older (AQLQ +12) (=0.5 increase equals response) at Week 24	Percentage of responders in the Asthma Quality of Life Questionnaire for 12 years and older (AQLQ(s) +12) (=0.5 increase equals response) at Week 24. Additional analysis will be conducted using pooled data from studies D5982C00007 and D5982C00008	24 weeks
Secondary	Percentage of responders in the St. George's Respiratory Questionnaire (SGRQ) (=4.0 unit decrease equals response) at Week 24	Percentage of responders in the St. George's Respiratory Questionnaire (SGRQ) (=4.0 unit decrease equals response) at Week 24	24 Weeks
Secondary	Onset of action on Day 1: Absolute change in FEV1 at 5 minutes on Day 1	Onset of action on Day 1: Absolute change in FEV1 at 5 minutes on Day 1	Day 1
Secondary	Time to first severe asthma exacerbation	Secondary end point(s) of Pooled Studies D5982C00007 and D5982C00008: Time to first severe asthma exacerbation	Up to 52 Weeks
Secondary	Rate of moderate/severe asthma exacerbations	Secondary end point(s) of Pooled Studies D5982C00007 and D5982C00008: Rate of moderate/severe asthma exacerbations	Up to 52 Weeks
Secondary	Time to first moderate/severe asthma exacerbation	Secondary end point(s) of Pooled Studies D5982C00007 and D5982C00008: Time to first moderate/severe asthma exacerbation	Up to 52 Weeks
Secondary	Rate of severe asthma exacerbations for participants with percent predicted FEV1 = 55% at baseline.	Secondary end point(s) of Pooled Studies D5982C00007 and D5982C00008: Rate of severe asthma exacerbations for participants with percent predicted FEV1 = 55% at baseline.	Up to 52 Weeks
Secondary	Rate of severe asthma exacerbations for participants with = 1 severe exacerbation in the 12 months prior to Visit 1.	Secondary end point(s) of Pooled Studies D5982C00007 and D5982C00008: Rate of severe asthma exacerbations for participants with = 1 severe exacerbation in the 12 months prior to Visit 1.	Up to 52 Weeks