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

Asthma Clinical Trial

— LOGOS  

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: NCT04609904
• Other study ID #: D5982C00008
• Secondary ID: 2023-505786-8820
• Status: Recruiting
• Phase: Phase 3
• Start date: March 1, 2021
• 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 > and/or = 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 halflives 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 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 LAMA, either alone or as part of an inhaled combination therapy, in the 12 weeks prior to Visit 1.

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
Austria	Research Site	Feldbach
Austria	Research Site	Linz
Austria	Research Site	Thalheim
Brazil	Research Site	Botucatu
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	São Paulo
Brazil	Research Site	Sorocaba
Brazil	Research Site	Uberlandia
China	Research Site	Anhui
China	Research Site	Baotou
China	Research Site	Beijing
China	Research Site	Beijing
China	Research Site	Beijing
China	Research Site	Changchun
China	Research Site	Changsha
China	Research Site	Changsha
China	Research Site	Changsha
China	Research Site	Changzhi
China	Research Site	Chengdu
China	Research Site	Chengdu
China	Research Site	Chengdu
China	Research Site	Chizhou
China	Research Site	Chongqing
China	Research Site	Chongqing
China	Research Site	Dongyang
China	Research Site	Fuzhou
China	Research Site	Gongguan
China	Research Site	Guangzhou
China	Research Site	Guangzhou
China	Research Site	Guangzhou
China	Research Site	Guangzhou
China	Research Site	Guangzhou
China	Research Site	Guangzhou
China	Research Site	Guiyang
China	Research Site	Haikou
China	Research Site	Haikou
China	Research Site	Hangzhou
China	Research Site	Hangzhou
China	Research Site	Hangzhou
China	Research Site	Hefei
China	Research Site	Hefei
China	Research Site	Hefei
China	Research Site	Hohhot
China	Research Site	Huai'an
China	Research Site	Huizhou
China	Research Site	Jinan
China	Research Site	Jinan
China	Research Site	Jinan
China	Research Site	Jinhua
China	Research Site	Kunming
China	Research Site	Kunming
China	Research Site	Lanzhou
China	Research Site	Liuzhou
China	Research Site	Luoyang
China	Research Site	Nan Chong
China	Research Site	Nanchang
China	Research Site	Nanjing
China	Research Site	Nanjing
China	Research Site	Nanjing
China	Research Site	Nanjing
China	Research Site	Nanning
China	Research Site	Qingdao
China	Research Site	Qingdao
China	Research Site	Shanghai
China	Research Site	Shanghai
China	Research Site	Shanghai
China	Research Site	Shanghai
China	Research Site	Shanghai
China	Research Site	Shanghai
China	Research Site	Shanghai
China	Research Site	Shanghai
China	Research Site	Shanghai
China	Research Site	Shanghai
China	Research Site	Shangrao
China	Research Site	Shantou
China	Research Site	Shaoxing
China	Research Site	Shengyang
China	Research Site	Shenyang
China	Research Site	Shenyang
China	Research Site	Shenzhen
China	Research Site	Shenzhen
China	Research Site	Shenzhen
China	Research Site	Shihezi
China	Research Site	Shijiazhuang
China	Research Site	Tai'an
China	Research Site	Taiyuan
China	Research Site	Taiyuan
China	Research Site	Taizhou
China	Research Site	Urumqi
China	Research Site	WeiFang
China	Research Site	Wenzhou
China	Research Site	Wuhan
China	Research Site	Wuhan
China	Research Site	Wuhu
China	Research Site	XI 'an
China	Research Site	Xi'an
China	Research Site	Xian
China	Research Site	Xinxiang
China	Research Site	Xuzhou
China	Research Site	Xuzhou
China	Research Site	Xuzhou
China	Research Site	Yangzhou
China	Research Site	Yantai
China	Research Site	Yinchuan
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China	Research Site	Yueyang
China	Research Site	Zhangzhou
China	Research Site	Zhanjiang
China	Research Site	Zhengzhou
China	Research Site	Zhengzhou City
China	Research Site	Zhuji
Colombia	Research Site	Barranquilla
Colombia	Research Site	Bogota
Colombia	Research Site	Cartagena
Colombia	Research Site	Manizales
Colombia	Research Site	Medellin
Colombia	Research Site	Medellin
Colombia	Research Site	Rionegro
Colombia	Research Site	San Gil
Costa Rica	Research Site	San José
Costa Rica	Research Site	Santa Ana
Czechia	Research Site	Brandys nad Labem
Czechia	Research Site	Jindrichuv Hradec
Czechia	Research Site	Liberec
Czechia	Research Site	Lovosice
Czechia	Research Site	Mlada Boleslav
Czechia	Research Site	Novy Bor
Czechia	Research Site	Praha 11
Czechia	Research Site	Praha 9
Czechia	Research Site	Rokycany
Czechia	Research Site	Strakonice
Czechia	Research Site	Teplice
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Germany	Research Site	Bamberg
Germany	Research Site	Berlin
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Germany	Research Site	Berlin
Germany	Research Site	Berlin
Germany	Research Site	Berlin
Germany	Research Site	Berlin
Germany	Research Site	Berlin
Germany	Research Site	Berlin
Germany	Research Site	Berlin
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Germany	Research Site	Fürstenwalde/Spree
Germany	Research Site	Geesthacht
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Germany	Research Site	Hannover
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Germany	Research Site	Koblenz
Germany	Research Site	Landsberg
Germany	Research Site	Leipzig
Germany	Research Site	Leipzig
Germany	Research Site	Leipzig
Germany	Research Site	Leipzig
Germany	Research Site	Mainz
Germany	Research Site	München-Pasing
Germany	Research Site	Rodgau-Dudenhofen
Germany	Research Site	Witten
Greece	Research Site	Alexandroupolis
Greece	Research Site	Athens
Greece	Research Site	Athens
Greece	Research Site	Athens
Greece	Research Site	Athens
Greece	Research Site	Athens
Greece	Research Site	Athens
Greece	Research Site	Corfu
Greece	Research Site	Exohi Thessaloniki
Greece	Research Site	Heraklion
Greece	Research Site	Ioannina
Greece	Research Site	Patras
Greece	Research Site	Thessaloniki
Greece	Research Site	Thessaloniki
Greece	Research Site	Thessaloniki
Greece	Research Site	Thessaloniki
Israel	Research Site	Ashqelon
Israel	Research Site	Beer Sheva
Israel	Research Site	Haifa
Israel	Research Site	Haifa
Israel	Research Site	Holon
Israel	Research Site	Jerusalem
Israel	Research Site	Jerusalem
Israel	Research Site	Kfar Saba
Israel	Research Site	Petach-Tikva
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Israel	Research Site	Rehovot
Israel	Research Site	Tel Aviv
Mexico	Research Site	Ciudad de Mexico
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Portugal	Research Site	Lisboa
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Portugal	Research Site	Matosinhos
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Puerto Rico	Research Site	Ponce
Puerto Rico	Research Site	Ponce
Russian Federation	Research Site	Chelyabinsk
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Russian Federation	Research Site	Kazan
Russian Federation	Research Site	Kemerovo
Russian Federation	Research Site	Kirov
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Omsk
Russian Federation	Research Site	Penza
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Russian Federation	Research Site	Saint Petersburg
Russian Federation	Research Site	Saratov
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Russian Federation	Research Site	Saratov
Russian Federation	Research Site	Tomsk
Russian Federation	Research Site	Ulyanovsk
Saudi Arabia	Research Site	Ar Riya?
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Saudi Arabia	Research Site	Jeddah
Saudi Arabia	Research Site	Makkah
Saudi Arabia	Research Site	Riyadh
Saudi Arabia	Research Site	Riyadh
Saudi Arabia	Research Site	Riyadh
Saudi Arabia	Research Site	Riyadh
Slovakia	Research Site	Bardejov
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Slovakia	Research Site	Levice
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Slovakia	Research Site	Nove Zamky
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South Africa	Research Site	Durban
South Africa	Research Site	Durban
South Africa	Research Site	Durban
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Sweden	Research Site	Lund
Sweden	Research Site	Stockholm
Sweden	Research Site	Uppsala
Turkey	Research Site	Adana
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Turkey	Research Site	Ankara
Turkey	Research Site	Bursa
Turkey	Research Site	Istanbul
Turkey	Research Site	Istanbul
Turkey	Research Site	Istanbul
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Turkey	Research Site	Pamukkale
United Kingdom	Research Site	Blackpool
United Kingdom	Research Site	Bradford
United Kingdom	Research Site	Corby
United Kingdom	Research Site	Hull
United Kingdom	Research Site	Leicester
United Kingdom	Research Site	Rhyl
United States	Research Site	Abingdon	Virginia
United States	Research Site	Acworth	Georgia
United States	Research Site	Albuquerque	New Mexico
United States	Research Site	Alpharetta	Georgia
United States	Research Site	Amarillo	Texas
United States	Research Site	Anaheim	California
United States	Research Site	Andrews	Texas
United States	Research Site	Atlanta	Georgia
United States	Research Site	Atlanta	Georgia
United States	Research Site	Atlanta	Georgia
United States	Research Site	Austin	Texas
United States	Research Site	Bakersfield	California
United States	Research Site	Baltimore	Maryland
United States	Research Site	Boca Raton	Florida
United States	Research Site	Boise	Idaho
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	Bronx	New York
United States	Research Site	Brooklyn	New York
United States	Research Site	Buford	Georgia
United States	Research Site	Burke	Virginia
United States	Research Site	Carlsbad	California
United States	Research Site	Caro	Michigan
United States	Research Site	Cedar Park	Texas
United States	Research Site	Chandler	Arizona
United States	Research Site	Chandler	Arizona
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	Clearwater	Florida
United States	Research Site	Clearwater	Florida
United States	Research Site	Colorado Springs	Colorado
United States	Research Site	Colorado Springs	Colorado
United States	Research Site	Columbus	Ohio
United States	Research Site	Conroe	Texas
United States	Research Site	Conway	Arkansas
United States	Research Site	Corning	New York
United States	Research Site	Corsicana	Texas
United States	Research Site	Cutler Bay	Florida
United States	Research Site	Dallas	Texas
United States	Research Site	Dallas	Texas
United States	Research Site	Davenport	Florida
United States	Research Site	DeBary	Florida
United States	Research Site	Denison	Texas
United States	Research Site	Denison	Texas
United States	Research Site	Elizabeth City	North Carolina
United States	Research Site	Escondido	California
United States	Research Site	Evansville	Indiana
United States	Research Site	Fall River	Massachusetts
United States	Research Site	Farmington Hills	Michigan
United States	Research Site	Fayetteville	Georgia
United States	Research Site	Forney	Texas
United States	Research Site	Gilbert	Arizona
United States	Research Site	Greensboro	North Carolina
United States	Research Site	Guttenberg	New Jersey
United States	Research Site	Hatboro	Pennsylvania
United States	Research Site	Hendersonville	Tennessee
United States	Research Site	Hialeah	Florida
United States	Research Site	High Point	North Carolina
United States	Research Site	Hinesville	Georgia
United States	Research Site	Hot Springs National Park	Arkansas
United States	Research Site	Houston	Texas
United States	Research Site	Houston	Texas
United States	Research Site	Huntersville	North Carolina
United States	Research Site	Huntington Beach	California
United States	Research Site	Huntington Beach	California
United States	Research Site	Inglewood	California
United States	Research Site	Jenkintown	Pennsylvania
United States	Research Site	Johnston	Rhode Island
United States	Research Site	Kissimmee	Florida
United States	Research Site	Knoxville	Tennessee
United States	Research Site	Lakeland	Florida
United States	Research Site	Lancaster	California
United States	Research Site	Lewisville	Texas
United States	Research Site	Little Rock	Arkansas
United States	Research Site	Little Rock	Arkansas
United States	Research Site	Long Beach	California
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	Marrero	Louisiana
United States	Research Site	Massapequa	New York
United States	Research Site	McAllen	Texas
United States	Research Site	McKinney	Texas
United States	Research Site	McKinney	Texas
United States	Research Site	McKinney	Texas
United States	Research Site	Mesquite	Texas
United States	Research Site	Miami	Florida
United States	Research Site	Milwaukee	Wisconsin
United States	Research Site	Milwaukee	Wisconsin
United States	Research Site	Mission Viejo	California
United States	Research Site	Monroe	North Carolina
United States	Research Site	Muscle Shoals	Alabama
United States	Research Site	Newark	Delaware
United States	Research Site	Newnan	Georgia
United States	Research Site	Normal	Illinois
United States	Research Site	North Dartmouth	Massachusetts
United States	Research Site	North Hollywood	California
United States	Research Site	North Las Vegas	Nevada
United States	Research Site	North Little Rock	Arkansas
United States	Research Site	North Port	Florida
United States	Research Site	North Richland Hills	Texas
United States	Research Site	Northridge	California
United States	Research Site	Ocean City	New Jersey
United States	Research Site	Oklahoma City	Oklahoma
United States	Research Site	Orange	California
United States	Research Site	Orlando	Florida
United States	Research Site	Palmdale	California
United States	Research Site	Peachtree City	Georgia
United States	Research Site	Pearland	Texas
United States	Research Site	Peoria	Illinois
United States	Research Site	Pflugerville	Texas
United States	Research Site	Pharr	Texas
United States	Research Site	Philadelphia	Pennsylvania
United States	Research Site	Philadelphia	Pennsylvania
United States	Research Site	Phoenix	Arizona
United States	Research Site	Pittsburgh	Pennsylvania
United States	Research Site	Plano	Texas
United States	Research Site	Port Jefferson	New York
United States	Research Site	Portland	Oregon
United States	Research Site	Portsmouth	New Hampshire
United States	Research Site	Rancho Cucamonga	California
United States	Research Site	Rochester	Michigan
United States	Research Site	Rochester	New York
United States	Research Site	Rock Hill	South Carolina
United States	Research Site	Roy	Utah
United States	Research Site	Sacramento	California
United States	Research Site	Sacramento	California
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 Diego	California
United States	Research Site	San Diego	California
United States	Research Site	San Diego	California
United States	Research Site	San Jose	California
United States	Research Site	Snellville	Georgia
United States	Research Site	Spartanburg	South Carolina
United States	Research Site	Stone Mountain	Georgia
United States	Research Site	Sugar Land	Texas
United States	Research Site	Sugar Land	Texas
United States	Research Site	Tampa	Florida
United States	Research Site	Troy	Michigan
United States	Research Site	Tucson	Arizona
United States	Research Site	Tucson	Arizona
United States	Research Site	Ventura	California
United States	Research Site	Victoria	Texas
United States	Research Site	Walnut Creek	California
United States	Research Site	Warrensburg	Missouri
United States	Research Site	Wheat Ridge	Colorado
United States	Research Site	White Marsh	Maryland
United States	Research Site	Williamsburg	Virginia
United States	Research Site	Zachary	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Austria,  Brazil,  China,  Colombia,  Costa Rica,  Czechia,  Germany,  Greece,  Israel,  Mexico,  Portugal,  Puerto Rico,  Russian Federation,  Saudi Arabia,  Slovakia,  South Africa,  Sweden,  Turkey,  United Kingdom, 

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