Status:
NOT_YET_RECRUITING
129-Xe MRI Study of Single Triple Therapy Inhaler Effects in COPD Patients With Moderate-severe Dyspnea and/or Poor Health Status With High or Low Risk of Exacerbation
Lead Sponsor:
Western University, Canada
Conditions:
Chronic Obstructive Pulmonary Disease (COPD)
Eligibility:
All Genders
50-85 years
Phase:
PHASE4
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 musca...
Detailed Description
This study will evaluate 60 COPD patients age 50-85 (equal numbers males and females) with persistent, moderate-severe dyspnea, poor health status and either: 1) low risk of exacerbation (n=30) or mod...
Eligibility Criteria
Inclusion
- 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:
- True sexual abstinence
- A vasectomized sexual partner
- Implanon®
- Female sterilization by tubal occlusion
- Effective intrauterine device (IUD)/levonogestrel intrauterine system (IUS)
- Depo-Provera™ injections
- Oral contraceptive
- Evra Patch™
- 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
- 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
Key Trial Info
Start Date :
March 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2027
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT07192016
Start Date
March 1 2026
End Date
October 1 2027
Last Update
September 25 2025
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