A Study to Compare the Efficacy, Safety and Tolerability of FF/UMEC/VI With FF/VI in 12-17-year-olds With Asthma

Asthma Clinical Trial

Official title:

A Phase 3, 24-week, Randomized, Double-blind, Parallel-group Bayesian Dynamic Borrowing Study Comparing the Efficacy, Safety, Tolerability and Pharmacokinetics of FF/UMEC/VI With FF/VI in 12-17-year-old Participants With Inadequately Controlled Asthma on Stable Maintenance Therapy With ICS/LABA

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05757102
• Other study ID #: 206867
• Status: Recruiting
• Phase: Phase 3
• Start date: April 24, 2023
• Est. completion date: January 15, 2027

Study information

• Verified date: May 2024
• Source: GlaxoSmithKline
• Contact: US GSK Clinical Trials Call Center
• Phone: 877-379-3718
• Email: GSKClinicalSupportHD[@]gsk.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary purpose of this study is to evaluate the effects of Fluticasone Furoate (FF)/ Umeclidinium (UMEC)/ Vilanterol (VI) on lung function compared with FF/VI after 24 weeks of treatment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 292
• Est. completion date: January 15, 2027
• Est. primary completion date: January 15, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

Inclusion Criteria:

• Participant must be 12 to 17 years of age (inclusive), at the time of signing the informed consent/assent.
• Participants who have a diagnosis of asthma as defined by the National Institutes of Health [NIH, 2020] at least 1 year prior to Visit 0.
• Participants who have required daily Inhaled corticosteroids (ICS)/ Long-Acting Beta2-Agonist (LABA) treatment for at least 12 weeks prior to Visit 0 with no changes to maintenance asthma medications during the 6 weeks immediately prior to Visit 0 (including no changes to a stable total ICS dose of >250 to <=500 microgram (mcg)/day fluticasone propionate, or equivalent).
• In the 1 year prior to Visit 1: A documented healthcare contact for acute asthma symptoms; OR A documented temporary change in asthma therapy for acute asthma symptoms, according to a prespecified asthma action plan (or equivalent).
• Participants with inadequately controlled asthma (ACQ-6 score =1.5) at Visit 1, despite ICS/LABA maintenance therapy.
• A best pre-bronchodilator FEV1 >40% to <=90% of the predicted normal value and a =12% increase in FEV1 with albuterol/salbutamol at Visit 1. Predicted values will be based on the European Respiratory Society (ERS) Global Lung Function Initiative.

Exclusion Criteria:

• Chest X-ray documented pneumonia in the 6 weeks prior to Visit 1.
• Any asthma exacerbation requiring a change in maintenance asthma therapy and/or the use of systemic corticosteroids for at least 3 days in the 6 weeks prior to Visit 1. (Participants requiring a temporary change in asthma therapy (e.g., oral corticosteroids or increased dose of ICS) to treat an exacerbation in the 6 weeks prior to Visit 1 are not explicitly excluded at Visit 1 provided that, at the Investigator's discretion, the participant's condition is stable after they have resumed their pre-exacerbation maintenance asthma therapy (without modification), returned to their baseline asthma status and they are considered appropriate for enrollment into this study of up to 6 months duration)
• History of Life-threatening Asthma
• Participants with current evidence of active pulmonary diseases or abnormalities other than asthma (e.g., pneumonia, active tuberculosis, significant bronchiectasis, etc.).
• Current smokers and users of other inhaled products for recreation with or without nicotine (defined as participants who use cigarettes, e-cigarettes, other/vaping-related devices, cigars or pipe tobacco]) within 12 months prior to Visit 1.

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• FF/UMEC/VI
FF/UMEC/VI will be administered.

Device:
• ELLIPTA
FF/UMEC/VI and FF/VI will be administered via ELLIPTA inhaler

Drug:
• FF/VI
FF/VI will be administered.

Locations

Country	Name	City	State
Argentina	GSK Investigational Site	Almagro	Caba
Argentina	GSK Investigational Site	Buenos Aires
Argentina	GSK Investigational Site	Buenos Aires
Argentina	GSK Investigational Site	Ciudad Autonoma Buenos aires	Buenos Aires
Argentina	GSK Investigational Site	Florencio Varela	Buenos Aires
Argentina	GSK Investigational Site	Florida	Buenos Aires
Argentina	GSK Investigational Site	Lanús	Buenos Aires
Argentina	GSK Investigational Site	Lobos	Buenos Aires
Argentina	GSK Investigational Site	Mar del Plata	Buenos Aires
Argentina	GSK Investigational Site	Rosario	Santa Fe
Argentina	GSK Investigational Site	Rosario	Santa Fe
Argentina	GSK Investigational Site	San Miguel de Tucuman	Tucuman
Argentina	GSK Investigational Site	San Rafael	Mendoza
Argentina	GSK Investigational Site	Santa Fe
Argentina	GSK Investigational Site	Vistalba	Mendoza
Australia	GSK Investigational Site	Burnie	Tasmania
Australia	GSK Investigational Site	Joondalup	Western Australia
Australia	GSK Investigational Site	Melbourne	Victoria
Australia	GSK Investigational Site	North Adelaide	South Australia
Australia	GSK Investigational Site	South Brisbane	Queensland
Chile	GSK Investigational Site	Santiago	Región Metro De Santiago
Chile	GSK Investigational Site	Santiago
Korea, Republic of	GSK Investigational Site	Cheongju-si	Chungcheongbuk-do
Korea, Republic of	GSK Investigational Site	Gwangju
Korea, Republic of	GSK Investigational Site	Incheon
Korea, Republic of	GSK Investigational Site	Seongnam
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Mexico	GSK Investigational Site	Chihuahua
Mexico	GSK Investigational Site	Ciudad de Mexico
Mexico	GSK Investigational Site	Guadalajara	Jalisco
Mexico	GSK Investigational Site	Mexico City
Mexico	GSK Investigational Site	Monterrey	Nuevo León
Mexico	GSK Investigational Site	San Juan del Río	Querétaro
Mexico	GSK Investigational Site	Zapopan	Jalisco
Turkey	GSK Investigational Site	Adana	Cukurova
Turkey	GSK Investigational Site	Ankara
Turkey	GSK Investigational Site	Istanbul
Turkey	GSK Investigational Site	Istanbul
Turkey	GSK Investigational Site	Konyaalti
United States	GSK Investigational Site	Albany	New York
United States	GSK Investigational Site	Aventura	Florida
United States	GSK Investigational Site	Bakersfield	California
United States	GSK Investigational Site	Birmingham	Alabama
United States	GSK Investigational Site	Boerne	Texas
United States	GSK Investigational Site	Bronx	New York
United States	GSK Investigational Site	Cincinnati	Ohio
United States	GSK Investigational Site	Cleveland	Ohio
United States	GSK Investigational Site	Colorado Springs	Colorado
United States	GSK Investigational Site	Columbia	Missouri
United States	GSK Investigational Site	Dallas	Texas
United States	GSK Investigational Site	Dayton	Ohio
United States	GSK Investigational Site	Denver	Colorado
United States	GSK Investigational Site	E. Amherst	New York
United States	GSK Investigational Site	Frisco	Texas
United States	GSK Investigational Site	Huntington Beach	California
United States	GSK Investigational Site	Kerrville	Texas
United States	GSK Investigational Site	Louisville	Kentucky
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	Milwaukee	Wisconsin
United States	GSK Investigational Site	Mission Viejo	California
United States	GSK Investigational Site	Missoula	Montana
United States	GSK Investigational Site	Mobile	Alabama
United States	GSK Investigational Site	Normal	Illinois
United States	GSK Investigational Site	North Charleston	South Carolina
United States	GSK Investigational Site	Ocean City	New Jersey
United States	GSK Investigational Site	Oklahoma City	Oklahoma
United States	GSK Investigational Site	Oklahoma City	Oklahoma
United States	GSK Investigational Site	Orlando	Florida
United States	GSK Investigational Site	Owensboro	Kentucky
United States	GSK Investigational Site	Paradise Valley	Arizona
United States	GSK Investigational Site	Phoenix	Arizona
United States	GSK Investigational Site	Rolling Hills Estates	California
United States	GSK Investigational Site	Savannah	Georgia
United States	GSK Investigational Site	Waco	Texas
United States	GSK Investigational Site	Walnut Creek	California

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Chile,  Korea, Republic of,  Mexico,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in trough forced expiratory volume in 1 second (FEV1) (Liters) at Week 24	FEV1 will be measured using spirometry.	Baseline (Week 0) and Week 24
Secondary	Change from Baseline in Asthma Control Questionnaire (7 items) (ACQ-7) (Scores on a scale)	ACQ-7 consists of 5 symptom related questions (nocturnal awakening, symptoms on waking in the morning, activity limitation, shortness of breath and wheeze with response options ranging from zero (no impairment/limitation) to 6 (total impairment/ limitation)), a question on rescue use and an additional item relating to lung function which is calculated based on FEV1. A score of less than or equal to (<=) 0.75 indicates well-controlled asthma and a score greater than or equal to (>=)1.5 indicates poorly controlled asthma.	Baseline (Week 0) and Week 24
Secondary	Change from Baseline in Asthma Control Questionnaire (6 items) (ACQ-6) (Scores on a scale)	ACQ-6 consists of 5 symptom related questions (nocturnal awakening, symptoms on waking in the morning, activity limitation, shortness of breath and wheeze with response options ranging from zero (no impairment/limitation) to 6 (total impairment/ limitation)) and a question on rescue bronchodilator use. A score of less than or equal to (<=) 0.75 indicates well-controlled asthma and a score greater than or equal to (>=)1.5 indicates poorly controlled asthma.	Baseline (Week 0) and Week 24
Secondary	Change from Baseline in Asthma Control Questionnaire (5 items) (ACQ-5) (Scores on a scale)	ACQ-5 consists of 5 symptom related questions (nocturnal awakening, symptoms on waking in the morning, activity limitation, shortness of breath and wheeze with response options ranging from zero (no impairment/limitation) to 6 (total impairment/ limitation). A score of less than or equal to (<=) 0.75 indicates well-controlled asthma and a score greater than or equal to (>=)1.5 indicates poorly controlled asthma.	Baseline (Week 0) and Week 24
Secondary	Number of Participants with a clinically important change from baseline in ACQ-7 Score	ACQ-7 consists of 5 symptom related questions (nocturnal awakening, symptoms on waking in the morning, activity limitation, shortness of breath and wheeze with response options ranging from zero (no impairment/limitation) to 6 (total impairment/ limitation)), a question on rescue use and an additional item relating to lung function which is calculated based on FEV1. A score of less than or equal to (<=) 0.75 indicates well-controlled asthma and a score greater than or equal to (>=)1.5 indicates poorly controlled asthma. A change of 0.5 in score suggests a clinically important change in score.	Week 24
Secondary	Number of Participants with a clinically important change from baseline in ACQ-6 Score	ACQ-6 consists of 5 symptom related questions (nocturnal awakening, symptoms on waking in the morning, activity limitation, shortness of breath and wheeze with response options ranging from zero (no impairment/limitation) to 6 (total impairment/ limitation)) and a question on rescue bronchodilator use. A score of less than or equal to (<=) 0.75 indicates well-controlled asthma and a score greater than or equal to (>=)1.5 indicates poorly controlled asthma. A change of 0.5 in score suggests a clinically important change in score.	Week 24
Secondary	Number of Participants with a clinically important change from baseline in ACQ-5 Score	ACQ-5 consists of 5 symptom related questions (nocturnal awakening, symptoms on waking in the morning, activity limitation, shortness of breath and wheeze with response options ranging from zero (no impairment/limitation) to 6 (total impairment/ limitation). A score of less than or equal to (<=) 0.75 indicates well-controlled asthma and a score greater than or equal to (>=)1.5 indicates poorly controlled asthma. A change of 0.5 in score suggests a clinically important change in score.	Week 24