Active not recruitingPHASE4INTERVENTIONAL

RELVAR Effects on Parasternal Muscle Activity, Diaphragm, and Ventilation in Severe COPD

This study is investigating how a specific inhaler medication, Relvar (which contains fluticasone furoate/vilanterol trifenatate), affects the breathing muscles and breathing patterns in adults with severe Chronic Obstructive Pulmonary Disease (COPD). Even if an inhaler doesn't improve lung function tests much, some people still feel better. The researchers believe this improvement might be due to the medication directly helping the breathing muscles, like the diaphragm and those in the upper chest. They will use special tools to measure how these muscles work and how people breathe while using the medication. This could help us understand why some people feel an important benefit from these medicines, making daily life easier for those with severe COPD.

At a glance

Status

Active not recruiting

Phase

PHASE4

Sponsor

University of Calgary

Enrolment target

Start

01 Apr 2016

Estimated completion

01 Jul 2026

Copd

What is this study about?

If you have severe COPD, you know it can make your lungs really stretched, which makes your main breathing muscle, the diaphragm, appear flatter and less effective. This can make it hard to be active and often leaves you feeling very breathless. Medications called long-acting bronchodilators, like the one in this study (Relvar), often help people feel much better, even if their lung function tests don't show a big improvement.

This study wants to understand why these medications make you feel better. The researchers think it might be because the medicine directly helps your breathing muscles, like those in your upper chest (called parasternals) and your diaphragm, work more efficiently. They also want to see how your overall breathing pattern changes.

By carefully looking at these muscle activities and breathing patterns, the study hopes to explain how Relvar helps people with severe COPD feel less breathless and more able to go about their daily lives. This information could lead to better ways to help people manage their COPD symptoms in the future.

Key takeaways

This study investigates how common COPD inhaler Relvar affects breathing muscles.
It aims to understand why some people feel more relief from COPD symptoms than lung function tests show.
The research focuses on the diaphragm and chest muscles, and overall breathing patterns.
Participants will undergo some special tests to measure muscle activity and breathing.
Findings could lead to a better understanding of COPD treatment and symptom relief.

Who may be eligible?

To join this study, you need to be an adult, aged 18 or over, with severe COPD that is stable and you can still get around. You should already be using long-acting bronchodilator medicines and taking all your prescribed medications regularly. You also need to be well enough to have a small medical procedure that involves a light sedative.

There are some reasons why you couldn't take part. These include if you're allergic to milk proteins or any part of the Relvar medication, or if you have certain heart problems like angina or a high risk of heart issues. You also can't have had a recent flare-up (exacerbation) of your COPD in the last two months, or any other serious health conditions that are not related to your breathing.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have severe, stable COPD?
Do you already take a long-acting bronchodilator medicine?
Are you able to attend clinic visits and undergo minor procedures with light sedation?
Have you NOT had a COPD flare-up in the last two months?
Do you NOT have any serious heart conditions or other significant illnesses?

Answer every question to see your result.

What does participation involve?

The study involves a few visits to the clinic where researchers will take measurements. You'll be given the Relvar medication to use. To understand how your breathing muscles are working, they will use a technique called 'parasternal EMG,' which involves placing small sensors on your skin to measure muscle activity. They'll also use 'phrenic magnetic stimulation' to check your diaphragm, which involves a special magnet placed over your neck or shoulder to gently stimulate the nerve that controls your diaphragm. Your breathing will also be monitored. The study will last for a certain period, and you'll have follow-up appointments to see how you're doing.

Potential risks and benefits

Participating in this study might offer you the benefit of close monitoring of your COPD and possibly insights into how your medication affects your body. However, there are potential small risks associated with the procedures, such as minor discomfort from the EMG sensors or magnetic stimulation, and risks linked to the mild sedation. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

University of Calgary
Verified postcode
Calgary, Canada

Common questions

What is COPD?

COPD stands for Chronic Obstructive Pulmonary Disease, which is a common lung condition that causes breathing difficulties.

What is Relvar?

Relvar is a common inhaler medication used to help people with COPD breathe more easily. It contains two medicines that work together.

Will this study change my current COPD treatment?

The study will test the effects of Relvar, which you might already be using or will be given as part of the study. Your overall long-term treatment plan will be discussed with the study doctors.

What are 'breathing muscles'?

These are the muscles in your chest and belly that help you breathe in and out, like your diaphragm and muscles in your upper chest.

Is the magnetic stimulation painful?

Magnetic stimulation is generally not painful; it creates a brief, gentle tapping or twitching sensation to assess muscle function.