Clinical trial for Chronic Obstructive Pulmonary Disease (COPD)
Official title 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
ClinicalTrials.gov ID: NCT07192016
What this study is testing
What is fluticasone furoate(FF)/umeclidinium (UMEC)/vilanterol(VI) (100/62.5/25) mcg?
fluticasone furoate(FF)/umeclidinium (UMEC)/vilanterol(VI) (100/62.5/25) mcg is an investigational medicine, given as an once-daily inhaled treatment, being studied as a potential treatment for chronic obstructive pulmonary disease (copd).
Also referred to as Trelegy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 85
You may be able to join if
- 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
You likely can't join if
- Patient has an implanted mechanically, electrically, or magnetically activated device or any metal in their body which cannot be removed, including...
- In the investigator's opinion, participant suffers from any physical, psychological or other condition(s) that might prevent performance of the MRI...
- 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
See the full eligibility 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:
- 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...
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- London, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include London, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.