Study Assessing the Long-term Effect of Dupilumab on Prevention of Lung Function Decline in Adult Patients With Uncontrolled Moderate to Severe Asthma

Asthma Clinical Trial

— ATLAS  

Official title:

A Randomized, Double-Blind, Placebo Controlled Study Assessing the Long-term Effect of Dupilumab on Prevention of Lung Function Decline in Patients With Uncontrolled Moderate to Severe Asthma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05097287
• Other study ID #: LPS16676
• Secondary ID: U1111-1266-28492
• Status: Recruiting
• Phase: Phase 4
• Start date: December 16, 2021
• Est. completion date: January 22, 2030

Study information

• Verified date: May 2024
• Source: Sanofi
• Contact: Trial Transparency email recommended (Toll free number for US &
• Phone: 800-633-1610
• Email: Contact-US[@]sanofi.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is an interventional, randomized, parallel group, treatment, Phase 3b/4, double blind, 2-arm study to assess the effect of dupilumab compared to standard of care therapy on preventing or slowing the rate of lung function decline in adult patients with uncontrolled moderate to severe asthma.

The estimated duration is 4±1 weeks of screening and run-in period, followed by a 3-year double blinded treatment period. There will be a post-treatment follow-up (FU) period up to 12 weeks.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1324
• Est. completion date: January 22, 2030
• Est. primary completion date: October 31, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Participant must be at least 18 (or the legal age of consent in the jurisdiction in which the study is taking place) years of age inclusive, at the time of signing the informed consent.

• Patients with a physician diagnosis of asthma (according to Global Initiative for Asthma (GINA) 2021) for =12 months

• Treatment with medium to high dose inhaled corticosteroids (ICS) in combination with a second controller (eg, long-acting beta-2 adrenergic receptor agonists (LABA), leukotriene receptor antagonists (LTRA) with a stable dose =1 month prior to Visit 1. Patients requiring a third controller for their asthma will be considered eligible for this study, and it should also be on stable dose =1 month prior to Visit 1. Patients requiring an additional controller as a fourth controller (Montelukast) for another type 2 comorbid condition such as allergic rhinitis will be considered eligible for this study, and should be on a stable dose for =1 month prior to Visit 1.

• Pre-bronchodilator forced expiratory volume (FEV1) = 80% of predicted normal for adults at Visits 1 and 2, prior to randomization

• Asthma Control Questionnaire 5-question version (ACQ-5) score =1.5 at Visits 1 and 2, prior to randomization.

• Variable airflow obstruction as documented by one or more of the following (at least 1 needs to be met):

i) Positive reversibility test: =12% and 200 mL improvement in FEV1 after SABA administration prior to randomization, or documented in the 24 months prior to Visit

1. OR, ii) Positive bronchial challenge test: fall in FEV1 of =20% with standard doses of methacholine, or =15% with standardized hyperventilation, hypertonic saline or mannitol challenge prior to randomization or documented in the 24 months prior to Visit 1 OR, iii) Average daily diurnal Peak flow variability of >10% over a 2-week period, documented in the past 24 months prior to Screening Visit 1. OR, iv) Airflow variability in clinic FEV1 >12% and 200 mL between visits outside of respiratory infections, documented in the past 24 months prior to Screening Visit 1. OR v) FEV1 increases by more than 12% and 200mL from baseline after 4 weeks of anti-inflammatory treatment.

• Reversibility test: Three attempts may be made during the Screening Period until the Baseline visit to meet the qualifying criteria for reversibility. This is only required if reversibility or other evidence of expiratory airflow limitation eligibility criteria was not performed within 24 months prior to Visit 1.

• FeNO =35 ppb at Visit 2, prior to randomization.

• History of =1 severe exacerbation(s) in the previous year before Visit1 defined as a deterioration of asthma requiring:

i) Use of systemic corticosteroids for =3 days; or ii) Hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids.

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

• History or clinical evidence of chronic obstructive pulmonary disease (COPD) including Asthma-COPD Overlap Syndrome (ACOS) or any other significant lung disease (eg, emphysema, lung fibrosis, sarcoidosis, interstitial lung disease, pulmonary hypertension, bronchiectasis, Churg-Strauss Syndrome).

• Severe asthma exacerbation requiring treatment with systemic corticosteroid (SCS) in the past month before visit 1 or during the screening period.

• Current acute bronchospasm or status asthmaticus.

• Diagnosed pulmonary (other than asthma) or systemic disease associated with elevated peripheral eosinophil counts.

• Severe concomitant illness(es) that, in the Investigator's judgment, would adversely affect the participant's participation in the study. Examples include, but are not limited to, participants with short life expectancy, uncontrolled diabetes, cardiovascular conditions, severe renal conditions (eg, participants on dialysis), or other severe endocrinological, gastrointestinal, metabolic, pulmonary, psychiatric, or lymphatic diseases. The specific justification for participants excluded under this criterion will be noted in the study documents (chart notes, case report forms [CRFs], etc).

• Patients with active tuberculosis (TB) or non-tuberculous mycobacterial infection, or a history of incompletely treated TB will be excluded from the study unless it is well documented by a specialist that the participant has been adequately treated and can now start treatment with a biologic agent, in the medical judgment of the Investigator and/or infectious disease specialist. Tuberculosis testing will be performed on a country by country basis, according to local guidelines if required by regulatory authorities or ethics boards, or if TB is suspected by the investigator

• Known or suspected immunodeficiency, including history of invasive opportunistic infections (eg, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, and aspergillosis) despite infection resolution, or otherwise recurrent infections of abnormal frequency or prolonged duration suggesting an immune-compromised status, as judged by the Investigator.

• Active malignancy or history of malignancy within 5 years before Visit 1 (screening visit), except completely treated in situ carcinoma of the cervix and completely treated and resolved non metastatic squamous or basal cell carcinoma of the skin.

• Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antifungals or receiving only symptomatic treatment (e.g. influenza or COVID-19) within 2 weeks before the screening visit (Visit 1) or during the screening period.

• History of human immunodeficiency virus (HIV) infection or positive HIV 1/2 serology at Visit 1 (screening visit).

• Diagnosed with, suspected of, or at high risk of endoparasitic infection, and/or use of antiparasitic drugs within 2 weeks before Visit 1 (screening visit) or during the screening and run-in period

• Current smoker (cigarette or e-cigarette) or cessation of smoking within 6 months prior to Visit 1.

• Previous smoker with a smoking history >10 pack-years.

• History of systemic hypersensitivity or anaphylaxis to dupilumab or any other biologic therapy, including any excipient.

• Any biologic therapy (including experimental treatments and dupilumab) or any other biologic therapy/immunosuppressant/immunomodulators within 4 weeks prior to V1 or 5 half-lives, whichever is longer.

• Treatment with a live (attenuated) vaccine within 4 weeks before Visit 1 (screening visit) or during the screening period.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Dupilumab
solution for injection subcutaneous
• Placebo
solution for injection subcutaneous

Locations

Country	Name	City	State
Belgium	Investigational Site Number : 0560001	Leuven
Belgium	Investigational Site Number : 0560003	Liège
Belgium	Investigational Site Number : 0560002	Sint-Lambrechts-Woluwe
Brazil	Santa Casa de Belo Horizonte - Hospital Emygdio Germano Site Number : 0760006	Belo Horizonte	Minas Gerais
Brazil	HOSPITAL DIA DO PULMAO Site Number : 0760002	Blumenau	Santa Catarina
Brazil	Hospital Sao Lucas da PUCRS Site Number : 0760005	Porto Alegre	Rio Grande Do Sul
Brazil	Irmandade da Santa Casa de Misericordia de Porto Alegre Site Number : 0760003	Porto Alegre	Rio Grande Do Sul
Brazil	Hospital Alemao Oswaldo Cruz Site Number : 0760007	Sao Paulo	São Paulo
Brazil	Hospital das Clinicas de Sao Paulo Site Number : 0760008	Sao Paulo	São Paulo
Brazil	Clinica de Alergia Martti Antila Site Number : 0760009	Sorocaba	São Paulo
Bulgaria	Investigational Site Number : 1000005	Dupnitsa
Bulgaria	Investigational Site Number : 1000003	Montana
Bulgaria	Investigational Site Number : 1000012	Plovdiv
Bulgaria	Investigational Site Number : 1000011	Ruse
Bulgaria	Investigational Site Number : 1000002	Sofia
Bulgaria	Investigational Site Number : 1000008	Sofia
Bulgaria	Investigational Site Number : 1000009	Sofia
Bulgaria	Investigational Site Number : 1000014	Sofia
Bulgaria	Investigational Site Number : 1000013	Vratsa
Canada	Investigational Site Number : 1240015	Ajax	Ontario
Canada	Investigational Site Number : 1240020	Kelowna	British Columbia
Canada	Investigational Site Number : 1240021	Mississauga	Ontario
Canada	Investigational Site Number : 1240010	Moncton	New Brunswick
Canada	Investigational Site Number : 1240014	Montreal	Quebec
Canada	Investigational Site Number : 1240017	Montreal	Quebec
Canada	Investigational Site Number : 1240023	Montreal	Quebec
Canada	Investigational Site Number : 1240018	Niagara Falls	Ontario
Canada	Investigational Site Number : 1240002	Quebec
Canada	Investigational Site Number : 1240025	Sherbrooke	Quebec
Canada	Investigational Site Number : 1240001	Toronto	Ontario
Canada	Investigational Site Number : 1240007	Toronto	Ontario
Canada	Investigational Site Number : 1240011	Toronto	Ontario
Canada	Investigational Site Number : 1240004	Vancouver	British Columbia
Canada	Investigational Site Number : 1240022	Vancouver	British Columbia
Canada	Investigational Site Number : 1240003	Windsor
Greece	Investigational Site Number : 3000003	Athens
Greece	Investigational Site Number : 3000004	Athens
Greece	Investigational Site Number : 3000005	Athens
Greece	Investigational Site Number : 3000006	Athens
Greece	Investigational Site Number : 3000007	Athens
Greece	Investigational Site Number : 3000010	Athens
Greece	Investigational Site Number : 3000002	Ioannina
Greece	Investigational Site Number : 3000008	N. Efkarpia
Greece	Investigational Site Number : 3000009	Palaio Faliro, Athens
Greece	Investigational Site Number : 3000001	Thessaloniki
Hungary	Investigational Site Number : 3480011	Budapest
Hungary	Investigational Site Number : 3480012	Budapest
Hungary	Investigational Site Number : 3480008	Debrecen
Hungary	Investigational Site Number : 3480005	Edelény
Hungary	Investigational Site Number : 3480004	Hajdunánás
Hungary	Investigational Site Number : 3480007	Mosonmagyaróvár
Hungary	Investigational Site Number : 3480003	Puspokladany
Hungary	Investigational Site Number : 3480001	Százhalombatta
Hungary	Investigational Site Number : 3480013	Szekszard
Hungary	Investigational Site Number : 3480006	Szombathely
India	Investigational Site Number : 3560011	Ahmedabad
India	Investigational Site Number : 3560003	Chandigarh
India	Investigational Site Number : 3560008	Coimbatore
India	Investigational Site Number : 3560016	Faridabad
India	Investigational Site Number : 3560001	Jaipur
India	Investigational Site Number : 3560019	Jodhpur
India	Investigational Site Number : 3560002	Kozhikode
India	Investigational Site Number : 3560014	Lucknow
India	Investigational Site Number : 3560006	Mangalore
India	Investigational Site Number : 3560018	Mysore
India	Investigational Site Number : 3560009	Nagpur
India	Investigational Site Number : 3560012	Nagpur
India	Investigational Site Number : 3560015	New Delhi
India	Investigational Site Number : 3560004	Vadodara
Ireland	Investigational Site Number : 3720003	Dublin 4	Dublin
Ireland	Investigational Site Number : 3720001	Wilton	Cork
Korea, Republic of	Investigational Site Number : 4100007	Busan	Busan-gwangyeoksi
Korea, Republic of	Investigational Site Number : 4100006	Daegu	Daegu-gwangyeoksi
Korea, Republic of	Investigational Site Number : 4100010	Incheon	Incheon-gwangyeoksi
Korea, Republic of	Investigational Site Number : 4100001	Seoul	Seoul-teukbyeolsi
Korea, Republic of	Investigational Site Number : 4100002	Seoul	Seoul-teukbyeolsi
Korea, Republic of	Investigational Site Number : 4100003	Seoul	Seoul-teukbyeolsi
Korea, Republic of	Investigational Site Number : 4100004	Seoul	Seoul-teukbyeolsi
Korea, Republic of	Investigational Site Number : 4100005	Seoul	Seoul-teukbyeolsi
Korea, Republic of	Investigational Site Number : 4100009	Seoul	Seoul-teukbyeolsi
Korea, Republic of	Investigational Site Number : 4100008	Wonju	Gangwon-do
Mexico	Investigational Site Number : 4840012	Chihuahua	Ciudad De Mexico
Mexico	Investigational Site Number : 4840001	Durango
Mexico	Investigational Site Number : 4840002	Guadalajara	Jalisco
Mexico	Investigational Site Number : 4840006	Mexico
Mexico	Investigational Site Number : 4840005	Monterrey	Nuevo León
Mexico	Investigational Site Number : 4840008	Monterrey	Nuevo León
Mexico	Investigational Site Number : 4840013	Oxaca	Ciudad De Mexico
Mexico	Investigational Site Number : 4840014	San Juan del Rio	Querétaro
Mexico	Investigational Site Number : 4840003	Veracruz
Mexico	Investigational Site Number : 4840010	Villahermosa	Tabasco
Oman	Investigational Site Number : 5120001	Muscat
Oman	Investigational Site Number : 5120002	Muscat
Puerto Rico	Cardiopulmonary Research Site Number : 8400126	Guaynabo
Puerto Rico	FDI Clinical Research Site Number : 8400121	San Juan
Puerto Rico	University of Puerto Rico Medical Sciences Campus Site Number : 8400128	San Juan
Romania	Investigational Site Number : 6420005	Bragadiru
Romania	Investigational Site Number : 6420002	Brasov
Romania	Investigational Site Number : 6420007	Brasov
Romania	Investigational Site Number : 6420004	Codlea
Romania	Investigational Site Number : 6420001	Deva
Romania	Investigational Site Number : 6420008	Pitesti
Romania	Investigational Site Number : 6420009	Timisoara
Saudi Arabia	Investigational Site Number : 6820008	Makkah
Slovakia	Investigational Site Number : 7030003	Levice
Slovakia	Investigational Site Number : 7030001	Poprad
Slovakia	Investigational Site Number : 7030002	Spisska Nova Ves
Slovakia	Investigational Site Number : 7030005	Topolcany
South Africa	Investigational Site Number : 7100006	Benoni
South Africa	Investigational Site Number : 7100001	Cape Town
South Africa	Investigational Site Number : 7100008	Cape Town
South Africa	Investigational Site Number : 7100012	Chatsworth
South Africa	Investigational Site Number : 7100003	Durban
South Africa	Investigational Site Number : 7100009	Durban
South Africa	Investigational Site Number : 7100004	Gatesville
South Africa	Investigational Site Number : 7100007	Gauteng
South Africa	Investigational Site Number : 7100002	Pretoria
Taiwan	Investigational Site Number : 1580001	Kaohsiung
Taiwan	Investigational Site Number : 1580005	New Taipei City
Taiwan	Investigational Site Number : 1580004	Taichung
Taiwan	Investigational Site Number : 1580002	Taipei
Taiwan	Investigational Site Number : 1580003	Yunlin
Turkey	Investigational Site Number : 7920007	Ankara
Turkey	Investigational Site Number : 7920008	Ankara
Turkey	Investigational Site Number : 7920003	Balcali Adana
Turkey	Investigational Site Number : 7920001	Istanbul
Turkey	Investigational Site Number : 7920006	Izmir
Turkey	Investigational Site Number : 7920009	Kayseri
Turkey	Investigational Site Number : 7920004	Kirikkale
Turkey	Investigational Site Number : 7920002	Mersin
United Arab Emirates	Investigational Site Number : 7840001	Abu Dhabi
United Kingdom	Investigational Site Number : 8260002	Bradford
United Kingdom	Investigational Site Number : 8260004	Cambridge	Cambridgeshire
United Kingdom	Investigational Site Number : 8260005	Liverpool
United Kingdom	Investigational Site Number : 8260001	Newcastle upon Tyne
United Kingdom	Investigational Site Number : 8260003	Oxford	Oxfordshire
United Kingdom	Investigational Site Number : 8260008	Wakefield	Leeds
United States	Appalachian Clinical Research Site Number : 8400129	Adairsville	Georgia
United States	Central Florida Pulmonary Group, PA Site Number : 8400035	Altamonte Springs	Florida
United States	University of Michigan Site Number : 8400030	Ann Arbor	Michigan
United States	Javara Inc Site Number : 8400087	Annapolis	Maryland
United States	Florida Center for Allergy and Asthma Research Site Number : 8400032	Aventura	Florida
United States	Kern Research, Inc Site Number : 8400037	Bakersfield	California
United States	REX Clinical Trials Site Number : 8400135	Beaumont	Texas
United States	Nebraska Medical Research Institute, Inc. Site Number : 8400055	Bellevue	Nebraska
United States	St. Luke's University Health Network Site Number : 8400099	Bethlehem	Pennsylvania
United States	Vitality Clinical Research Site Number : 8400142	Beverly Hills	California
United States	TTS Research Site Number : 8400009	Boerne	Texas
United States	Urban Health Plan Site Number : 8400144	Bronx	New York
United States	Burke Internal Medicine INC Site Number : 8400170	Burke	Virginia
United States	Chandler Clinical Trials (Elite Clinical Network) Site Number : 8400147	Chandler	Arizona
United States	National Allergy and ENT Site Number : 8400092	Charleston	South Carolina
United States	University of Virginia Site Number : 8400082	Charlottesville	Virginia
United States	Rush University Medical Center Site Number : 8400146	Chicago	Illinois
United States	Bogan Sleep Consultants Site Number : 8400102	Columbia	South Carolina
United States	Urgent Care Clinical Trials and KUR Research Site Number : 8400169	Columbia	Maryland
United States	Avant Research Associates LLC Site Number : 8400117	Crowley	Louisiana
United States	Cullman Research Center, LLC Site Number : 8400001	Cullman	Alabama
United States	Beautiful Minds Clinical Research Center Site Number : 8400141	Cutler Bay	Florida
United States	DCT-Baxter Research, LLC dba Discovery Clinical Trials Site Number : 8400123	Dallas	Texas
United States	Revival Research Institute, LLC Site Number : 8400097	Dearborn	Michigan
United States	Omega Research Site Number : 8400023	DeBary	Florida
United States	North Texas Allergy and Asthma Center Site Number : 8400139	Denton	Texas
United States	Alpha Clinical Research Georgia Site Number : 8400116	Dunwoody	Georgia
United States	Genesis Clinical Research & Consulting Site Number : 8400050	Fall River	Massachusetts
United States	ASCADA Research Site Number : 8400076	Fullerton	California
United States	Clinical Research of Gastonia Site Number : 8400012	Gastonia	North Carolina
United States	ADAC Research, PA Site Number : 8400026	Greenville	South Carolina
United States	Advanced Respiratory and Sleep Medicine Site Number : 8400151	Hickory	North Carolina
United States	C & R Research Services USA Site Number : 8400067	Houston	Texas
United States	Clear Brook Medical Associates Site Number : 8400080	Houston	Texas
United States	Advanced Respiratory and Sleep Medicine Site Number : 8400056	Huntersville	North Carolina
United States	Orange County Allergy & Asthma Specialists Site Number : 8400162	Huntington Beach	California
United States	Brengle Family Medicine Site Number : 8400157	Indianapolis	Indiana
United States	Jersey City Breathing Center Site Number : 8400143	Jersey City	New Jersey
United States	Florida Lung, Asthma, and Sleep Specialists Site Number : 8400098	Kissimmee	Florida
United States	Revive Research Institute Site Number : 8400100	Lathrup Village	Michigan
United States	Main Street Physician's Care Site Number : 8400077	Little River	South Carolina
United States	Allergy And Asthma Research Institute Site Number : 8400160	Louisville	Kentucky
United States	Metroplex Pulmonary and Sleep Center Site Number : 8400014	McKinney	Texas
United States	Texas Institute of Cardiology Site Number : 8400003	McKinney	Texas
United States	Tandem Clinical Research, LLC Site Number : 8400163	Metairie	Louisiana
United States	Biotech Pharmaceutical Group, LLC Site Number : 8400073	Miami	Florida
United States	Ivetmar Medical Group LLC Site Number : 8400063	Miami	Florida
United States	Research Institute of South Florida Site Number : 8400079	Miami	Florida
United States	Floridian Clinical Research Site Number : 8400091	Miami Lakes	Florida
United States	Lapis Clinical Research Site Number : 8400112	Mooresville	North Carolina
United States	NewportNativeMD, Inc Site Number : 8400054	Newport Beach	California
United States	Pediatric Subspecialty Faculty Site Number : 8400137	Orange	California
United States	HMD Research LLC Site Number : 8400024	Orlando	Florida
United States	Allergy & Asthma Specialists, PSC Site Number : 8400007	Owensboro	Kentucky
United States	Temple Lung Center Site Number : 8400038	Philadelphia	Pennsylvania
United States	Pulmonary Associates Site Number : 8400155	Phoenix	Arizona
United States	Allergy & Clinical Immunology Associates Site Number : 8400042	Pittsburgh	Pennsylvania
United States	Prospective Research Innovations Inc. Site Number : 8400131	Rancho Cucamonga	California
United States	Health Concepts Site Number : 8400006	Rapid City	South Dakota
United States	Romedica, LLC Site Number : 8400043	Rochester	Michigan
United States	Mercy Medical Group - Midtown, Primary and Specialty Care Site Number : 8400164	Sacramento	California
United States	Andante Research Site Number : 8400140	San Antonio	Texas
United States	Aeroallergy Research Laboratories Of Savannah Inc Site Number : 8400114	Savannah	Georgia
United States	Syed Research Consultants, LLC Site Number : 8400015	Sheffield	Alabama
United States	NorthShore University HealthSystem Clinical Trials Center Site Number : 8400138	Skokie	Illinois
United States	Great Lakes Research Institute Site Number : 8400111	Southfield	Michigan
United States	JSV Clinical Research Study, Inc Site Number : 8400150	Tampa	Florida
United States	MACOA Site Number : 8400130	Tempe	Arizona
United States	Toledo Institute of Clinical Research Site Number : 8400051	Toledo	Ohio
United States	DM Clinical Research Site Number : 8400103	Tomball	Texas
United States	Del Sol Research Management, LLC Site Number : 8400017	Tucson	Arizona
United States	Vital Prospects Clinical Research Institute, P.C. Site Number : 8400093	Tulsa	Oklahoma
United States	Integrated Research of Inland, INC Site Number : 8400156	Upland	California
United States	Allianz Research Institute Site Number : 8400018	Westminster	California
United States	Allergy Asthma Specialists of Maryland Site Number : 8400119	White Marsh	Maryland
United States	Southeastern Research Center Site Number : 8400153	Winston-Salem	North Carolina
United States	WOODLAND CLINIC MEDICAL GROUP Site Number : 8400171	Woodland	California
United States	Respiratory Medicine Research Institute of Michigan, PLC Site Number : 8400107	Ypsilanti	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Sanofi	Regeneron Pharmaceuticals

Countries where clinical trial is conducted

United States,  Belgium,  Brazil,  Bulgaria,  Canada,  Greece,  Hungary,  India,  Ireland,  Korea, Republic of,  Mexico,  Oman,  Puerto Rico,  Romania,  Saudi Arabia,  Slovakia,  South Africa,  Taiwan,  Turkey,  United Arab Emirates,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of change from week 8 to week 52 on post-BD FEV1 slope in FeNO population	Rate of change from week 8 to week 52 on post-bronchodilator (BD) forced expiratory volume in one second (FEV1) slope in FeNO population.	Week 8 to Week 52
Secondary	Rate of change from week 8 to week 52 on post-BD FEV1 slope in the Total population	Rate of change from week 8 to week 52 on post-BD FEV1 slope in the Total population.	Week 8 to Week 52
Secondary	Rate of change from week 8 to week 104 on post-BD FEV1 slope in the FeNO population	Rate of change from week 8 to week 104 on post-BD FEV1 slope in the FeNO population.	Week 8 to Week 104
Secondary	Change from baseline to week 52 in pre-BD FEV1 in FeNO and Total populations	Change from baseline to week 52 in pre-BD FEV1 in FeNO and Total populations.	Baseline to Week 52
Secondary	Change from baseline to week 52 in post-BD FEV1 in FeNO and Total populations	Change from baseline to week 52 in post-BD FEV1 in FeNO and Total populations.	Baseline to Week 52
Secondary	Annualized severe exacerbation rate during the 52-week period in FeNO and Total populations	Exacerbation defined as a deterioration of asthma requiring use of systemic corticosteroids for =3 days; or hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids.	Baseline to Week 52
Secondary	Change from baseline to week 52 in fractional exhaled nitric oxide (FeNO) levels in FeNO and Total populations	Change from baseline to week 52 in FeNO levels in FeNO and Total populations.	Baseline to Week 52
Secondary	Change from baseline to week 52 in Asthma Control Questionnaire 7 items (ACQ-7) in FeNO and Total populations	ACQ-7 was designed to measure both the adequacy of asthma control and change in asthma control. A global score ranges between 0 (totally controlled) and 6 (severely uncontrolled). Higher score indicates lower asthma control.	Baseline to Week 52
Secondary	Change from baseline to week 52 in pre-BD FEV1 % predicted in FeNO and Total populations	Change from baseline to week 52 in pre-BD FEV1 % predicted in FeNO and Total populations.	Baseline to Week 52
Secondary	Change from baseline to week 52 in Forced Vital Capacity (FVC) in FeNO and Total populations	Change from baseline to week 52 in FVC in FeNO and Total populations.	Baseline to Week 52
Secondary	Rate of change from week 8 to week 104 on post-BD FEV1 slope in Total Population	Rate of change from week 8 to week 104 on post-BD FEV1 slope in Total Population.	Week 8 to Week 104
Secondary	Change from baseline to week 104 in pre-BD FEV1 in FeNO and Total populations	Change from baseline to week 104 in pre-BD FEV1 in FeNO and Total populations.	Baseline to Week 104
Secondary	Change from baseline to week 104 in post-BD FEV1 in FeNO and Total populations	Change from baseline to week 104 in post-BD FEV1 in FeNO and Total populations.	Baseline to Week 104
Secondary	Annualized severe exacerbation rate during the 104-week period in FeNO and Total populations	Exacerbation defined as a deterioration of asthma requiring use of systemic corticosteroids for =3 days; or hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids.	Baseline to Week 104
Secondary	Change from baseline to week 104 in FeNO levels in FeNO and Total populations	Change from baseline to week 104 in FeNO levels in FeNO and Total populations.	Baseline to Week 104
Secondary	Change from baseline to week 104 in ACQ-7 in FeNO and Total populations	ACQ-7 was designed to measure both the adequacy of asthma control and change in asthma control. A global score ranges between 0 (totally controlled) and 6 (severely uncontrolled). Higher score indicates lower asthma control.	Baseline to Week 104
Secondary	Change from baseline to week 104 in pre-BD FEV1 % predicted in FeNO and Total populations	Change from baseline to week 104 in pre-BD FEV1 % predicted in FeNO and Total populations.	Baseline to Week 104
Secondary	Change from baseline to week 104 FVC in FeNO and Total populations	Change from baseline to week 104 FVC in FeNO and Total populations.	Baseline to Week 104
Secondary	Change from baseline to week 52 in Asthma Quality Of Life Questionnaire with Standardized Activities (AQLQ(S)) in FeNO and Total populations	The AQLQ (S) was designed as a self-administered patient reported outcome to measure the functional impairments that are most troublesome to patients as a result of their asthma. A global score is calculated ranging from 1 to 7. Higher scores indicate better quality of life.	Baseline to Week 52
Secondary	Change from baseline to week 104 in AQLQ(S) in FeNO and Total populations	The AQLQ (S) was designed as a self-administered patient reported outcome to measure the functional impairments that are most troublesome to patients as a result of their asthma. A global score is calculated ranging from 1 to 7. Higher scores indicate better quality of life.	Baseline to Week 104
Secondary	Rate of change from week 8 to week 156 on post-BD FEV1 slope in FeNO and Total populations	Rate of change from week 8 to week 156 on post-BD FEV1 slope in FeNO and Total populations.	Week 8 to Week 156
Secondary	Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)	Incidence of TEAEs and SAEs.	Baseline to Week 168
Secondary	Incidence of adverse events of special interest (AESIs)	Incidence of AESIs.	Baseline to Week 168

External Links

•   LPS16676 Asthma clinical study website