Recruiting

FF/UMEC/VI

Sponsor:

Western University, Canada

Code:

NCT07192016

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Interventions

fluticasone furoate(FF)/umeclidinium (UMEC)/vilanterol(VI) (100/62.5/25) mcg

Study Details

Brief summary:

The goal of this study is to study how 12-weeks daily (and optional 48-weeks) single inhaler triple therapy (fluticasone furoate (FF)-an inhaled corticosteroid; umeclidinium (UMEC)-a long-acting muscarinic antagonist; vilanterol (VI)-a long-acting β2-adrenergic agonist) works to treat adults with COPD. The investigators will compare the effects of this medication on adults with COPD who are at low risk of a flare-up and adults with COPD who are at high risk of a flare-up. The main questions it aims to answer are:

  • Does FF/UMEC/VI improve ventilation defect percent as measured on 129-Xenon MRI in adults with moderate-severe COPD
  • Evaluate the relationships between the ventilation defect percent and lung function test results

Participants will:

  • Take the inhaler FF/UMEC/VI once daily for 12-weeks (optional 48-weeks)
  • visit Robarts 2 times (with optional 3rd visit) for tests and imaging

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Study ID

NCT07192016

Start date

Apr 24, 2026

Status verified date

Jul, 2026

Completion date

Oct, 2027

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • patient understands study procedures and is willing to participate in the study as indicated by the patient's signature
  • provision of written, informed consent prior to any study specific procedures
  • males and females 50-85 years of age
  • stable COPD, currently on dual therapy LAMA/LABA or ICS/LABA or initial maintenance therapy for at least 3 months
  • mMRC score ≥2 and/or CAT score ≥10
  • Low risk subgroup: participant has experienced ≤1 exacerbation in the past year and no hospitalizations for COPD High risk subgroup: participant has experienced ≥2 exacerbations in the past year
  • Female of childbearing potential (after menarche) must ensure that they are using an effective form of birth control for at least 2 months prior to each imaging visit. Examples of effective birth control include:

1. True sexual abstinence
2. A vasectomized sexual partner
3. Implanon®
4. Female sterilization by tubal occlusion
5. Effective intrauterine device (IUD)/levonogestrel intrauterine system (IUS)
6. Depo-Provera™ injections
7. Oral contraceptive
8. Evra Patch™
9. Nuvaring™
  • Female permanently sterile due to: 1) documented hysterectomy, 2) documented bilateral salpingectomy, and 3) documented bilateral oophorectomy
  • Postmenopausal female: defined as female with no menses for 12 months without an alternative medical cause
  • Females of childbearing potential (after menarche) must agree to use a highly effective form of birth control, as defined above, from enrollment, throughout the study duration, and 8 weeks after last dose of study drug, with negative urine pregnancy test taken within 24 hr of any planned CT examination at Visit-1 through Visit 3
  • Male participants who are sexually active with a woman who can still have children, must agree to use a double barrier method of contraception (male condom with diaphragm or male condom with cervical cap) from the first dose of the study drug until 8 weeks after last dose

Exclusion Criteria:

  • Patient has an implanted mechanically, electrically, or magnetically activated device or any metal in their body which cannot be removed, including but not limited to pacemakers, neurostimulators, biostimulators, implanted insulin pumps, aneurysm clips, bioprosthesis, artificial limb, metallic fragment or foreign body, shunt, surgical staples (including clips or metallic sutures and/or ear implants) (at the discretion of the MRI Technologist)
  • In the investigator's opinion, participant suffers from any physical, psychological or other condition(s) that might prevent performance of the MRI or CT, such as severe claustrophobia
  • Participants who are pregnant, breastfeeding or have a positive pregnancy test at initial screening visit
  • Participant is unable to perform spirometry or plethysmography maneuvers
  • Participant is unable to perform MRI and CT breath-hold maneuvers
  • Participant has an unstable cardiovascular, gastro-intestinal, hepatic, renal, neurologic, metabolic or psychiatric disease
  • Participation in any clinical trial of an investigational agent or procedure within three months prior to screening or during the study
  • Known history of allergy or reaction to the study drug formulation
  • Participant has a blood pressure of >150 mmHg systolic or >95 mmHg diastolic on more than 2 measurements done >5 minutes apart at Visit-1
  • Participants with a recently (<2 months) documented diagnosis of asthma

Study Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Participants with persistent moderate-severe COPD

Participants with moderate to severe COPD will be evaluated during and after a twelve week trial of triple therapy (ICS/LABA/LAMA) for changes in 129Xe MRI ventilation percent defect, pulmonary function measurements.

Interventions

fluticasone furoate(FF)/umeclidinium (UMEC)/vilanterol(VI) (100/62.5/25) mcg

The investigational drug is a single Ellipta inhaler containing 100 ug fluticasone furoate(inhaled corticosteroid), 62.5 ug umeclidinium(long-acting muscarinic antagonist) and 25 ug vilanterol(long-acting β2-adrenergic agonist). The drug is delivered in an Ellipta inhaler in a single dose once daily.

Primary outcome measure

  • Measure the effect of FF/UMEC/VI therapy on VDP [ Time Frame: 12-weeks and optional 48-weeks ]
  • Measure the effect of FF/UMEC/VI on FEV1 [ Time Frame: at 12-weeks and optional 48-weeks ]

Central Contacts and Locations

Central contacts

Locations

Robarts Research Institute; The University of Western Ontario; London Health Sciences Centre

Recruiting

London, Ontario, Canada, N6A 5B7

Contacts

Principal Investigator:

Grace Parraga, PhD

More Information

Sponsor

Western University, Canada

Last update posted

Jul 31, 2026

Last verified

Jul, 2026

Keywords

  • Pulmonary Function
  • COPD
  • 129-Xenon
  • Magnetic Resonance Imaging

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-11. This information was provided to ClinicalTrials.gov by Western University, Canada on 2026-07-31.