Single Inhaler Triple Therapy for COPD: 12-Week Test of FF/UMEC/VI in Moderate-to-Severe Dyspnea

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 4 trial will enroll 60 adults with stable COPD, 50–85 years old, evenly split by sex, and stratified into low- and high-exacerbation risk. Participants will take the FF/UMEC/VI inhaler once daily for 12 weeks, with an optional 48-week extension, and will undergo comprehensive lung testing and imaging before and after treatment, including 129-Xe MRI and chest CT, as well as spirometry, plethysmography, oscillometry, FeNO, DLco, and patient-reported questionnaires. The study will evaluate changes in ventilation defect percent on 129-Xe MRI and explore correlations with standard lung function measures. Two to three study visits at Robarts and affiliated centers will occur, with safety monitoring and quality-of-life assessments throughout.

Why it matters

Who can join: the full rules

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

Where it's running

• Robarts Research Institute; The University of Western Ontario; London Health Sciences Centre
  London, Ontario, Canada Recruiting

Study contacts

• Principal investigator: Grace Parraga, PhD — Robarts Research Institute, The University of Western Ontario
• Study coordinator: Grace E Parraga, PhD
• Email: gparraga@uwo.ca
• Phone: 519-931-5265

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.