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Phase 3 N=359 Randomized Double-blind Treatment

Efficacy and Safety of Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) in Chinese Participants With Inadequately Controlled Asthma

Asthma

Enrolled (actual)
359
Serious AEs
2.5%
Results posted
Aug 2025
Primary outcome: Primary: Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 (100ug FF) — 0.078; 0.136 Liters

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
FF/VI (Drug); FF/UMEC/VI (Drug); ELLIPTA (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
GlaxoSmithKline
Primary completion
Aug 2024

Outcome Measures

OutcomeResultp-value
PRIMARY
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 (100ug FF)
0.078; 0.136
SECONDARY
Change From Baseline in Trough FEV1 at Week 12 (200ug FF)
0.121; 0.116
SECONDARY
Change From Baseline in Asthma Control Questionnaire (ACQ-7) Total Score at Week 12
-0.940; -0.968; -0.926; -0.814

Summary

The study aims to evaluate the efficacy, safety and tolerability of FF/UMEC/VI compared with FF/VI via ELLIPTA® inhaler in Chinese participants with inadequately controlled asthma. ELLIPTA is a registered trademark of GlaxoSmithKline group of companies.

Eligibility Criteria

Inclusion criteria

  • Participant must be 18 years or older at the time of signing the informed consent.
  • Documented history asthma diagnosis as defined by the Global Initiative for Asthma (GINA) at least one year prior to Visit 0.
  • Participants with inadequately controlled asthma (ACQ-6 score >=1.5) despite Inhaled Corticosteroids/Long-Acting Beta-2-Agonists (ICS/LABA) maintenance therapy at Visit 1.
  • Participants who require daily ICS/LABA 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 dose of ICS of greater than [>]250 micrograms (mcg) per day fluticasone propionate [FP, or equivalent]).
  • A best pre-bronchodilator morning (AM) FEV1 >=30 percent (%) and less than ( =12% and >=200 milliliters (mL) increase in FEV1 between 20 and 60 minutes following 4 inhalations of albuterol/salbutamol aerosol at Visit 1.
  • All participants must be able to replace their current Short-Acting Beta-2-Agonists (SABA) inhaler with albuterol/salbutamol aerosol inhaler at Visit 1 as needed for the duration of the study. Participants must be judged capable of withholding albuterol/salbutamol for at least 6 hours prior to study visits.
  • Male or female participants following contraceptive/barrier requirements and it should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies: Is a woman of non-childbearing potential (WONCBP) or a woman of childbearing potential (WOCBP) who agrees to follow the contraceptive guidance during the study.
  • Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

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 in the 6 weeks prior to Visit 1.
  • Participants with the diagnosis of chronic obstructive pulmonary disease, as per Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines, including all of the following:
  • History of exposure to risk factors (especially tobacco smoke, occupational dusts and chemicals, smoke from home cooking and heating fuels).
  • A post-albuterol/salbutamol FEV1/Forced Vital Capacity (FVC) ratio of =40 years of age.
  • Participants with current evidence of pneumonia, active tuberculosis, lung cancer, significant bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases or abnormalities other than asthma.
  • Immune suppression (e.g., Human Immunodeficiency virus [HIV], Lupus) or other risk factors for pneumonia (e.g., neurological disorders affecting control of the upper airway, such as Parkinson's Disease, Myasthenia Gravis). Participants at potentially high risk (e.g., very low Body Mass Index [BMI], severely malnourished, or very low FEV1) will only be included at the discretion of the Investigator.
  • Participants with historical or current evidence of clinically significant cardiovascular, neurological, psychiatric, renal, hepatic, immunological, gastrointestinal, urogenital, nervous system, musculoskeletal, skin, sensory, endocrine (including uncontrolled diabetes or thyroid disease) or hematological abnormalities that are uncontrolled. Significant is defined as any disease that, in the opinion of the Investigator, would put the safety of the participant at risk through participation, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study.
  • Unstable liver disease as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, esophageal or gastric varices or persistent jaund
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04937387). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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