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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04718389
Other study ID # 206785
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date January 26, 2021
Est. completion date September 26, 2025

Study information

Verified date April 2024
Source GlaxoSmithKline
Contact US GSK Clinical Trials Call Center
Phone 877-379-3718
Email GSKClinicalSupportHD@gsk.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will assess whether switching participants who have benefitted from mepolizumab or benralizumab to GSK3511294 (Depemokimab) is non-inferior to maintaining current treatment on the annualized rate of clinically significant exacerbations in participants with severe asthma with an eosinophilic phenotype. Throughout the study, all participants will continue their non-biologic Baseline standard of care (SoC) asthma treatment.


Recruitment information / eligibility

Status Recruiting
Enrollment 1700
Est. completion date September 26, 2025
Est. primary completion date September 26, 2025
Accepts healthy volunteers No
Gender All
Age group 12 Years and older
Eligibility Key inclusion criteria for study: - Adult and adolescent participants more than or equal to (>=)12 years of age, at the time of signing the informed consent/assent. - Participants who have a documented physician diagnosis of asthma for >=2 years that meets the National Heart, Lung, and Blood Institute guidelines (NHLBI) or Global Initiative for Asthma (GINA) guidelines. - Participants receiving either mepolizumab 100 milligrams (mg) or benralizumab 30 mg for >=12 months prior to screening and have a documented benefit to therapy assessed by either: (i) >=50% reduction in exacerbation frequency since initiating treatment, or (ii) >=50% reduction in maintenance OCS use since initiating treatment, or (iii) No exacerbations in the past 6 months whilst receiving anti-IL-5/5R therapy and an Asthma Control Questionnaire (ACQ)-5 score of less than or equal to (<=)1.5 at screening. - A well-documented requirement for regular treatment with medium to high dose ICS in the 12 months prior to Visit 1 with or without maintenance OCS. The maintenance ICS dose must be >=440 micrograms (mcg) fluticasone propionate (FP) hydrofluoroalkane (HFA) product daily, or clinically comparable. Participants who are treated with medium dose ICS will also need to be treated with a LABA to qualify for inclusion. - Current treatment with at least one additional controller medication, besides ICS [for example (e.g.), LABA, LAMA, leukotriene receptor antagonist (LTRA), or theophylline]. Key exclusion criteria for study: - Participants with presence of a known pre-existing, clinically important lung condition other than asthma. This includes (but is not limited to) current infection, bronchiectasis, pulmonary fibrosis, bronchopulmonary aspergillosis, or diagnoses of emphysema or chronic bronchitis (chronic obstructive pulmonary disease other than asthma) or a history of lung cancer. - Participants with other conditions that could lead to elevated eosinophils such as hyper-eosinophilic syndromes including (but not limited to) Eosinophilic Granulomatosis with Polyangiitis (EGPA, formerly known as Churg-Strauss Syndrome) or Eosinophilic Esophagitis. - A current malignancy or previous history of cancer in remission for less than 12 months prior to screening (Participants that had localized carcinoma of the skin which was resected for cure will not be excluded). - Cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice. - Participants with current diagnosis of vasculitis. Participants with high clinical suspicion of vasculitis at screening will be evaluated and current vasculitis excluded prior to enrolment. - Participants who have received Omalizumab (Xolair), dupilumab (Dupixent) or reslizumab (Cinqair/Cinqaero) within 130 days prior to Visit 1. - Participants who have received any Monoclonal antibody (mAb) within 5 half-lives of Visit 1. - Corrected QT interval using Fridericia's formula (QTcF) >=450 milliseconds (msec) or QTcF >=480 msec for participants with Bundle Branch Block at screening Visit 1. - Current smokers or former smokers with a smoking history of >=10 pack years (number of pack years equal to [number of cigarettes per day/20] times number of years smoked). A former smoker is defined as a participant who quit smoking at least 6 months prior to Visit 1. - Participants with allergy/intolerance to a mAb or biologic. Key exclusion criteria for randomization: - Evidence of a clinically significant abnormality in the 12-lead electrocardiogram (ECG) over-read conducted at Screening Visit 1, based on the evaluation of the investigator, or QTcF >=450 msec or QTcF >=480 msec for participants with Bundle Branch Block, at randomization Visit 2. - Participants with a clinically significant asthma exacerbation in the 7 days prior to randomization should have their randomization visit delayed until the investigator considers the participant's asthma to be stable. If the 8-week screening period has elapsed, then the participant should be considered a run-in failure. - Any changes in the dose or regimen of Baseline ICS and/or additional controller medication (except for treatment of an exacerbation) during the run-in period.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
GSK3511294 (Depemokimab)
GSK3511294 (Depemokimab) will be provided in a single-use prefilled syringe (PFS).
Mepolizumab
Mepolizumab will be provided in a single-use PFS.
Benralizumab
Benralizumab will be provided in a single-use PFS.
Placebo
Placebo will be a sterile liquid formulation.
Drug:
Standard of care (SoC)
Non-biologic SoC will include inhaled corticosteroid (ICS) plus at least one other controller, long-acting beta-2-agonist (LABA), long-acting muscarinic antagonist (LAMA), with or without maintenance oral corticosteroids (OCS).
Device:
Pre-filled Syringes (PFS)
PFS will include glass barrel with pre-staked needle and plunger.

Locations

Country Name City State
Australia GSK Investigational Site Adelaide South Australia
Australia GSK Investigational Site Bedford Park South Australia
Australia GSK Investigational Site Box Hill Victoria
Australia GSK Investigational Site Cairns Queensland
Australia GSK Investigational Site Clayton Victoria
Australia GSK Investigational Site Fitzroy Victoria
Australia GSK Investigational Site Frankston Victoria
Australia GSK Investigational Site Macquarie University New South Wales
Australia GSK Investigational Site Nedlands Western Australia
Australia GSK Investigational Site North Adelaide South Australia
Australia GSK Investigational Site Prahran Victoria
Australia GSK Investigational Site South Brisbane Queensland
Australia GSK Investigational Site South Brisbane Queensland
Australia GSK Investigational Site Sydney New South Wales
Australia GSK Investigational Site Toorak Gardens South Australia
Australia GSK Investigational Site Westmead New South Wales
Australia GSK Investigational Site Woodville South South Australia
Austria GSK Investigational Site Feldbach
Austria GSK Investigational Site Wien
Canada GSK Investigational Site Ajax Ontario
Canada GSK Investigational Site Calgary Alberta
Canada GSK Investigational Site Edmonton Alberta
Canada GSK Investigational Site Greenfield Park Quebec
Canada GSK Investigational Site Moncton New Brunswick
Canada GSK Investigational Site Ottawa Ontario
Canada GSK Investigational Site Pierrefonds Quebec
Canada GSK Investigational Site Quebec
Canada GSK Investigational Site Quebec City Quebec
Canada GSK Investigational Site Toronto Ontario
Canada GSK Investigational Site Toronto Ontario
Canada GSK Investigational Site Trois-Rivieres Quebec
Canada GSK Investigational Site Windsor Ontario
Finland GSK Investigational Site Tampere
Finland GSK Investigational Site Turku
France GSK Investigational Site Amiens
France GSK Investigational Site Annecy Cedex
France GSK Investigational Site Antony
France GSK Investigational Site Besançon
France GSK Investigational Site Brest Cedex
France GSK Investigational Site Brest cedex
France GSK Investigational Site Caen
France GSK Investigational Site Cannes Cedex
France GSK Investigational Site Cholet
France GSK Investigational Site Dijon Cedex
France GSK Investigational Site La Tronche
France GSK Investigational Site Le Mans Cedex
France GSK Investigational Site Lille Cedex
France GSK Investigational Site Lille cedex
France GSK Investigational Site Lyon cedex 04
France GSK Investigational Site Marseille
France GSK Investigational Site Marseille
France GSK Investigational Site Montfermeil
France GSK Investigational Site Montivilliers
France GSK Investigational Site Montpellier Cedex 5
France GSK Investigational Site Nantes cedex
France GSK Investigational Site Nice cedex 1
France GSK Investigational Site Paris
France GSK Investigational Site Paris
France GSK Investigational Site Paris cedex 15
France GSK Investigational Site Paris Cedex 18
France GSK Investigational Site Pontoise
France GSK Investigational Site Rouen cedex
France GSK Investigational Site Strasbourg
France GSK Investigational Site Suresnes
France GSK Investigational Site Toulouse
France GSK Investigational Site Tours cedex 9
Germany GSK Investigational Site Aschaffenburg Bayern
Germany GSK Investigational Site Berlin
Germany GSK Investigational Site Berlin
Germany GSK Investigational Site Berlin
Germany GSK Investigational Site Bonn
Germany GSK Investigational Site Bonn Nordrhein-Westfalen
Germany GSK Investigational Site Darmstadt Hessen
Germany GSK Investigational Site Frankfurt Hessen
Germany GSK Investigational Site Frankfurt Hessen
Germany GSK Investigational Site Fuerstenwalde Brandenburg
Germany GSK Investigational Site Geesthacht Schleswig-Holstein
Germany GSK Investigational Site Halle Sachsen-Anhalt
Germany GSK Investigational Site Halle Sachsen-Anhalt
Germany GSK Investigational Site Hamburg
Germany GSK Investigational Site Hannover Niedersachsen
Germany GSK Investigational Site Heidelberg Baden-Wuerttemberg
Germany GSK Investigational Site Koblenz Rheinland-Pfalz
Germany GSK Investigational Site Landsberg Bayern
Germany GSK Investigational Site Leipzig Sachsen
Germany GSK Investigational Site Leipzig Sachsen
Germany GSK Investigational Site Leipzig Sachsen
Germany GSK Investigational Site Luebeck Schleswig-Holstein
Germany GSK Investigational Site Luebeck Schleswig-Holstein
Germany GSK Investigational Site Magdeburg
Germany GSK Investigational Site Mainz Rheinland-Pfalz
Germany GSK Investigational Site München Bayern
Germany GSK Investigational Site Neu isenburg Hessen
Germany GSK Investigational Site Rheine Nordrhein-Westfalen
Germany GSK Investigational Site Schleswig Schleswig-Holstein
Germany GSK Investigational Site Weissenburg Bayern
Ireland GSK Investigational Site Cork
Ireland GSK Investigational Site Dublin
Ireland GSK Investigational Site Dublin
Israel GSK Investigational Site Beer Sheva
Israel GSK Investigational Site Haifa
Israel GSK Investigational Site Jerusalem
Israel GSK Investigational Site Jerusalem
Israel GSK Investigational Site Kfar Saba
Israel GSK Investigational Site Petah Tikva
Israel GSK Investigational Site Ramat-Gan
Israel GSK Investigational Site Tel Aviv
Israel GSK Investigational Site Zrifin
Italy GSK Investigational Site Ancona Marche
Italy GSK Investigational Site Bari Puglia
Italy GSK Investigational Site Bari Puglia
Italy GSK Investigational Site Bergamo Lombardia
Italy GSK Investigational Site Bologna Emilia-Romagna
Italy GSK Investigational Site Brescia Lombardia
Italy GSK Investigational Site Catania Sicilia
Italy GSK Investigational Site Cona Emilia-Romagna
Italy GSK Investigational Site Firenze Toscana
Italy GSK Investigational Site Genova Liguria
Italy GSK Investigational Site Mantova Lombardia
Italy GSK Investigational Site Milano Lombardia
Italy GSK Investigational Site Milano Lombardia
Italy GSK Investigational Site Milano Lombardia
Italy GSK Investigational Site Milano Lombardia
Italy GSK Investigational Site Modena Emilia-Romagna
Italy GSK Investigational Site Monserrato Sardegna
Italy GSK Investigational Site Napoli Campania
Italy GSK Investigational Site Padova
Italy GSK Investigational Site Palermo Sicilia
Italy GSK Investigational Site Pavia Lombardia
Italy GSK Investigational Site Perugia Umbria
Italy GSK Investigational Site Pisa Toscana
Italy GSK Investigational Site Reggio Emilia Emilia-Romagna
Italy GSK Investigational Site Roma Lazio
Italy GSK Investigational Site Salerno Campania
Italy GSK Investigational Site Salerno Campania
Italy GSK Investigational Site Sassari Sardegna
Italy GSK Investigational Site Siena Toscana
Italy GSK Investigational Site Torino Piemonte
Italy GSK Investigational Site Treviso Veneto
Italy GSK Investigational Site Trieste Friuli-Venezia-Giulia
Italy GSK Investigational Site Verona Veneto
Japan GSK Investigational Site Aichi
Japan GSK Investigational Site Aichi
Japan GSK Investigational Site Aichi
Japan GSK Investigational Site Akita
Japan GSK Investigational Site Ehime
Japan GSK Investigational Site Fukuoka
Japan GSK Investigational Site Fukuoka
Japan GSK Investigational Site Fukuoka
Japan GSK Investigational Site Fukuoka
Japan GSK Investigational Site Fukuoka
Japan GSK Investigational Site Fukuoka
Japan GSK Investigational Site Fukushima
Japan GSK Investigational Site Gifu
Japan GSK Investigational Site Hiroshima
Japan GSK Investigational Site Hiroshima
Japan GSK Investigational Site Hiroshima
Japan GSK Investigational Site Hokkaido
Japan GSK Investigational Site Hokkaido
Japan GSK Investigational Site Hyogo
Japan GSK Investigational Site Hyogo
Japan GSK Investigational Site Ibaraki
Japan GSK Investigational Site Ibaraki
Japan GSK Investigational Site Ishikawa
Japan GSK Investigational Site Iwate
Japan GSK Investigational Site Kagawa
Japan GSK Investigational Site Kagoshima
Japan GSK Investigational Site Kanagawa
Japan GSK Investigational Site Kanagawa
Japan GSK Investigational Site Kanagawa
Japan GSK Investigational Site Kanagawa
Japan GSK Investigational Site Kanagawa
Japan GSK Investigational Site Mie
Japan GSK Investigational Site Mie
Japan GSK Investigational Site Mie
Japan GSK Investigational Site Miyagi
Japan GSK Investigational Site Nagano
Japan GSK Investigational Site Niigata
Japan GSK Investigational Site Okayama
Japan GSK Investigational Site Okayama
Japan GSK Investigational Site Osaka
Japan GSK Investigational Site Osaka
Japan GSK Investigational Site Osaka
Japan GSK Investigational Site Osaka
Japan GSK Investigational Site Osaka
Japan GSK Investigational Site Osaka
Japan GSK Investigational Site Osaka
Japan GSK Investigational Site Osaka
Japan GSK Investigational Site Osaka
Japan GSK Investigational Site Shimane
Japan GSK Investigational Site Shizuoka
Japan GSK Investigational Site Shizuoka
Japan GSK Investigational Site Tochigi
Japan GSK Investigational Site Tokyo
Japan GSK Investigational Site Tokyo
Japan GSK Investigational Site Tokyo
Japan GSK Investigational Site Tokyo
Japan GSK Investigational Site Tokyo
Japan GSK Investigational Site Tokyo
Japan GSK Investigational Site Tokyo
Japan GSK Investigational Site Tokyo
Japan GSK Investigational Site Tokyo
Japan GSK Investigational Site Tokyo
Japan GSK Investigational Site Tokyo
Japan GSK Investigational Site Tokyo
Japan GSK Investigational Site Tokyo
Japan GSK Investigational Site Tokyo
Japan GSK Investigational Site Tokyo
Japan GSK Investigational Site Toyama
Japan GSK Investigational Site Wakayama
Netherlands GSK Investigational Site Arnhem
Netherlands GSK Investigational Site Breda
Netherlands GSK Investigational Site Deventer
Netherlands GSK Investigational Site Eindhoven
Netherlands GSK Investigational Site Enschede
Netherlands GSK Investigational Site Harderwijk
Netherlands GSK Investigational Site Leeuwarden
Netherlands GSK Investigational Site Nijmegen
Netherlands GSK Investigational Site Rotterdam
Netherlands GSK Investigational Site Zwolle
Norway GSK Investigational Site Bergen
Norway GSK Investigational Site Lørenskog
Portugal GSK Investigational Site Coimbra
Portugal GSK Investigational Site Guarda
Portugal GSK Investigational Site Lisboa
Portugal GSK Investigational Site Matosinhos
Portugal GSK Investigational Site Porto
Puerto Rico GSK Investigational Site Guaynabo
Slovenia GSK Investigational Site Golnik
Spain GSK Investigational Site Alcorcón (Madrid)
Spain GSK Investigational Site Almería
Spain GSK Investigational Site Badalona
Spain GSK Investigational Site Barcelona
Spain GSK Investigational Site Barcelona
Spain GSK Investigational Site Barcelona
Spain GSK Investigational Site Barcelona
Spain GSK Investigational Site Barcelona
Spain GSK Investigational Site Basurto/Bilbao
Spain GSK Investigational Site Benalmádena
Spain GSK Investigational Site Elche
Spain GSK Investigational Site Esplugues de Llobregat
Spain GSK Investigational Site Granada
Spain GSK Investigational Site Jerez de la Frontera
Spain GSK Investigational Site Madrid
Spain GSK Investigational Site Madrid
Spain GSK Investigational Site Madrid
Spain GSK Investigational Site Madrid
Spain GSK Investigational Site Madrid
Spain GSK Investigational Site Málaga
Spain GSK Investigational Site Málaga
Spain GSK Investigational Site Mérida (Badajoz)
Spain GSK Investigational Site Pamplona
Spain GSK Investigational Site Pozuelo De Alarcón Madrid
Spain GSK Investigational Site Salamanca
Spain GSK Investigational Site Sán Crístobál De Lá Láguná
Spain GSK Investigational Site Santander
Spain GSK Investigational Site Santiago De Compostela. La Coruña.
Spain GSK Investigational Site Valencia
Spain GSK Investigational Site Valencia
Spain GSK Investigational Site Via-Real (Castellón)
Spain GSK Investigational Site Vitoria - Gasteiz
Spain GSK Investigational Site Zaragoza
Sweden GSK Investigational Site Linköping
Sweden GSK Investigational Site Lund
Sweden GSK Investigational Site Östersund
Sweden GSK Investigational Site Stockholm
Sweden GSK Investigational Site Uppsala
Switzerland GSK Investigational Site Aarau
Switzerland GSK Investigational Site Basel
Switzerland GSK Investigational Site Liestal
Switzerland GSK Investigational Site St. Gallen
Taiwan GSK Investigational Site Changhua
Taiwan GSK Investigational Site Gueishan Township,Taoyuan County
Taiwan GSK Investigational Site Taichung
Taiwan GSK Investigational Site Taichung
Taiwan GSK Investigational Site Taipei
Taiwan GSK Investigational Site Taipei
United Kingdom GSK Investigational Site Airdrie Lanarkshire
United Kingdom GSK Investigational Site Belfast
United Kingdom GSK Investigational Site Birmingham
United Kingdom GSK Investigational Site Bradford
United Kingdom GSK Investigational Site Bristol Gloucestershire
United Kingdom GSK Investigational Site Cottingham, East Yorkshire
United Kingdom GSK Investigational Site Edinburgh
United Kingdom GSK Investigational Site Exeter.
United Kingdom GSK Investigational Site Glasgow
United Kingdom GSK Investigational Site Glasgow
United Kingdom GSK Investigational Site Liverpool Merseyside
United Kingdom GSK Investigational Site London
United Kingdom GSK Investigational Site Newcastle Upon Tyne
United Kingdom GSK Investigational Site Nottingham Nottinghamshire
United Kingdom GSK Investigational Site Oxford
United Kingdom GSK Investigational Site Portsmouth
United Kingdom GSK Investigational Site Preston
United Kingdom GSK Investigational Site Wakefield
United States GSK Investigational Site Albuquerque New Mexico
United States GSK Investigational Site Altoona Pennsylvania
United States GSK Investigational Site Amarillo Texas
United States GSK Investigational Site Amarillo Texas
United States GSK Investigational Site Ann Arbor Michigan
United States GSK Investigational Site Asheville North Carolina
United States GSK Investigational Site Aurora Colorado
United States GSK Investigational Site Aventura Florida
United States GSK Investigational Site Bakersfield California
United States GSK Investigational Site Baltimore Maryland
United States GSK Investigational Site Bangor Maine
United States GSK Investigational Site Bellingham Washington
United States GSK Investigational Site Bethlehem Pennsylvania
United States GSK Investigational Site Birmingham Alabama
United States GSK Investigational Site Boston Massachusetts
United States GSK Investigational Site Brick New Jersey
United States GSK Investigational Site Bronx New York
United States GSK Investigational Site Bronx New York
United States GSK Investigational Site Brooklyn New York
United States GSK Investigational Site Burlington Massachusetts
United States GSK Investigational Site Calhoun Georgia
United States GSK Investigational Site Chesterfield Missouri
United States GSK Investigational Site Chevy Chase Maryland
United States GSK Investigational Site Cincinnati Ohio
United States GSK Investigational Site Cincinnati Ohio
United States GSK Investigational Site Clearwater Florida
United States GSK Investigational Site Cleveland Ohio
United States GSK Investigational Site Colorado Springs Colorado
United States GSK Investigational Site Colorado Springs Colorado
United States GSK Investigational Site Columbia South Carolina
United States GSK Investigational Site Corvallis Oregon
United States GSK Investigational Site Cypress Texas
United States GSK Investigational Site Dallas Texas
United States GSK Investigational Site Dallas Texas
United States GSK Investigational Site Dallas Texas
United States GSK Investigational Site Dallas Texas
United States GSK Investigational Site Dearborn Michigan
United States GSK Investigational Site Denver Colorado
United States GSK Investigational Site DuBois Pennsylvania
United States GSK Investigational Site Encinitas California
United States GSK Investigational Site Evansville Indiana
United States GSK Investigational Site Flint Michigan
United States GSK Investigational Site Fort Lauderdale Florida
United States GSK Investigational Site Gainesville Florida
United States GSK Investigational Site Greenfield Wisconsin
United States GSK Investigational Site Happy Valley Oregon
United States GSK Investigational Site Hendersonville Tennessee
United States GSK Investigational Site Hershey Pennsylvania
United States GSK Investigational Site Horseheads New York
United States GSK Investigational Site Houston Texas
United States GSK Investigational Site Houston Texas
United States GSK Investigational Site Huntersville North Carolina
United States GSK Investigational Site Huntington Beach California
United States GSK Investigational Site Jackson Mississippi
United States GSK Investigational Site Jacksonville Florida
United States GSK Investigational Site Kerrville Texas
United States GSK Investigational Site Kissimmee Florida
United States GSK Investigational Site Knoxville Tennessee
United States GSK Investigational Site La Jolla California
United States GSK Investigational Site Lakewood Colorado
United States GSK Investigational Site Lexington Kentucky
United States GSK Investigational Site Lincoln Nebraska
United States GSK Investigational Site Litchfield Park Arizona
United States GSK Investigational Site Long Beach California
United States GSK Investigational Site Los Angeles California
United States GSK Investigational Site Loxahatchee Groves Florida
United States GSK Investigational Site McAllen Texas
United States GSK Investigational Site Miami Florida
United States GSK Investigational Site Miami Florida
United States GSK Investigational Site Miami Florida
United States GSK Investigational Site Miami Florida
United States GSK Investigational Site Miami Florida
United States GSK Investigational Site Miami Florida
United States GSK Investigational Site Miami Florida
United States GSK Investigational Site Miami Lakes Florida
United States GSK Investigational Site Miami Lakes Florida
United States GSK Investigational Site Miami Lakes Florida
United States GSK Investigational Site Miami Lakes Florida
United States GSK Investigational Site Miami Springs Florida
United States GSK Investigational Site Milwaukee Wisconsin
United States GSK Investigational Site Minneapolis Minnesota
United States GSK Investigational Site Mobile Alabama
United States GSK Investigational Site Murray Utah
United States GSK Investigational Site New Bedford Massachusetts
United States GSK Investigational Site New Haven Connecticut
United States GSK Investigational Site New Hyde Park New York
United States GSK Investigational Site Newport Beach California
United States GSK Investigational Site North Dartmouth Massachusetts
United States GSK Investigational Site North Palm Beach Florida
United States GSK Investigational Site Northfield Illinois
United States GSK Investigational Site Northfield New Jersey
United States GSK Investigational Site Northridge California
United States GSK Investigational Site Oak Park Illinois
United States GSK Investigational Site Omaha Nebraska
United States GSK Investigational Site Orlando Florida
United States GSK Investigational Site Orlando Florida
United States GSK Investigational Site Orlando Florida
United States GSK Investigational Site Orlando Florida
United States GSK Investigational Site Overland Park Kansas
United States GSK Investigational Site Owensboro Kentucky
United States GSK Investigational Site Oxnard California
United States GSK Investigational Site Pensacola Florida
United States GSK Investigational Site Philadelphia Pennsylvania
United States GSK Investigational Site Phoenix Arizona
United States GSK Investigational Site Pittsburgh Pennsylvania
United States GSK Investigational Site Rancho Cucamonga California
United States GSK Investigational Site Redondo Beach California
United States GSK Investigational Site Redwood City California
United States GSK Investigational Site Richmond Virginia
United States GSK Investigational Site Rio Rancho New Mexico
United States GSK Investigational Site Riverdale New Jersey
United States GSK Investigational Site Rock Hill South Carolina
United States GSK Investigational Site Saint Charles Missouri
United States GSK Investigational Site Saint Louis Missouri
United States GSK Investigational Site San Antonio Texas
United States GSK Investigational Site San Antonio Texas
United States GSK Investigational Site San Antonio Texas
United States GSK Investigational Site San Antonio Texas
United States GSK Investigational Site San Diego California
United States GSK Investigational Site Santa Monica California
United States GSK Investigational Site Scottsboro Alabama
United States GSK Investigational Site Scottsdale Arizona
United States GSK Investigational Site Seattle Washington
United States GSK Investigational Site Sebring Florida
United States GSK Investigational Site Shreveport Louisiana
United States GSK Investigational Site Skokie Illinois
United States GSK Investigational Site Spartanburg South Carolina
United States GSK Investigational Site Stafford Texas
United States GSK Investigational Site Stonecrest Georgia
United States GSK Investigational Site Tallahassee Florida
United States GSK Investigational Site Tarzana California
United States GSK Investigational Site Toms River New Jersey
United States GSK Investigational Site Upland California
United States GSK Investigational Site Warren Michigan
United States GSK Investigational Site Warwick Rhode Island
United States GSK Investigational Site Waxahachie Texas
United States GSK Investigational Site West Bloomfield Michigan
United States GSK Investigational Site Wheat Ridge Colorado
United States GSK Investigational Site White Marsh Maryland
United States GSK Investigational Site Williamsburg Virginia
United States GSK Investigational Site Wilmington North Carolina
United States GSK Investigational Site Winston-Salem North Carolina
United States GSK Investigational Site Winston-Salem North Carolina
United States GSK Investigational Site Woodland California
United States GSK Investigational Site Wyomissing Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
GlaxoSmithKline Iqvia Pty Ltd

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Canada,  Finland,  France,  Germany,  Ireland,  Israel,  Italy,  Japan,  Netherlands,  Norway,  Portugal,  Puerto Rico,  Slovenia,  Spain,  Sweden,  Switzerland,  Taiwan,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Annualized rate of clinically significant exacerbations over 52 weeks Clinically significant exacerbations of asthma are defined by worsening of asthma which requires use of systemic corticosteroids and/or hospitalization and/or Emergency Department (ED) visit. Annualized rate of exacerbations will be calculated as number of exacerbations experienced by the participant divided by the length of time the participant is measured on. Up to Week 52
Secondary Weighted mean change from Baseline in St. George's Respiratory Questionnaire (SGRQ) total score The SGRQ is a well-established instrument, comprising 51 questions designed to measure Quality of Life in participants with diseases of airway obstruction. Higher score indicates worse quality of life. Baseline (Day 1) and up to Week 52
Secondary Weighted mean change from Baseline in Asthma Control Questionnaire-5 (ACQ-5) score The ACQ-5 is a five-item questionnaire, which has been developed as a measure of participants' asthma control that can be quickly and easily completed. The five questions enquire about the frequency and/or severity of symptoms (nocturnal awakening on waking in the morning, activity limitation, and shortness of breath, wheeze) over the previous week. The response options for all these questions consist of a zero (no impairment/limitation) to six (total impairment/ limitation) scale. Higher score indicates more limitations. Baseline (Day 1) and up to Week 52
Secondary Weighted mean change from Baseline in pre-bronchodilator forced expiratory volume in one second (FEV1) FEV1 is a measure of pulmonary function and is the maximum amount of air that can be forced out in one second after taking a deep breath. FEV1 will be measured using spirometry. Baseline (Day 1) and up to Week 52
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