Ongoing Clinical Trials for Obstructive Airways Disorder
Currently, there is 1 ongoing clinical trial investigating treatments for patients with obstructive airways disorder, specifically focusing on individuals who also have heart failure. This trial is examining a combination inhaled medication to improve breathing and heart function during physical activity.
Clinical trial locations
Study on the Effects of Umeclidinium and Vilanterol in Patients with COPD and Heart Failure
This clinical trial is investigating how a combination inhaled medication affects patients who have both chronic obstructive pulmonary disease (COPD) and heart failure. The study focuses on understanding whether this treatment can improve the heart’s ability to pump blood during exercise.
Main inclusion criteria:
- Patients must be at least 40 years old with a confirmed diagnosis of COPD
- Evidence of reduced airflow, where the amount of air that can be blown out in one second (FEV1) is less than 80% of expected, and the ratio of FEV1 to total air blown out (FVC) is less than 0.7
- A smoking history of at least ten pack-years, meaning the equivalent of smoking one pack of cigarettes daily for ten years
- Lung hyperinflation, shown by having more air remaining in the lungs after breathing out than normal (residual volume more than 135% of expected)
- Stable heart failure with a left ventricle ejection fraction between 35% and 55%, which measures how effectively the heart pumps blood with each beat
- Clear ultrasound imaging of the heart must be possible from a specific angle
Main exclusion criteria:
- History of severe allergic reactions to the study medication
- Recent heart attack or stroke within the past 6 months
- Uncontrolled high blood pressure or other unstable serious heart conditions
- Pregnancy or breastfeeding
- Current participation in another clinical trial
- Severe liver or kidney disease
- History of drug or alcohol abuse in the past year
- Inability to perform the required physical activities for the study
- Any other medical condition that study doctors believe would make participation unsafe
Focus and goals:
The trial aims to determine whether treatment with umeclidinium bromide and vilanterol can improve heart function during physical activity in patients with both COPD and heart failure. Participants will receive either the active treatment (Anoro Ellipta) or a placebo. The medication is delivered as an inhalation powder taken once daily, with doses of 55 micrograms of umeclidinium and 22 micrograms of vilanterol.
Throughout the study, participants will undergo various tests to measure their heart and lung function. These include exercise tests on a cycle-ergometer, lung function measurements, and imaging techniques such as MRI and echocardiography, which uses sound waves to create pictures of the heart. The tests help researchers understand how the treatment affects the heart’s pumping ability, lung volumes, and overall exercise capacity.
Investigational drugs:
The main medication being tested is Umeclidinium/Vilanterol, a combination inhaled medication. Umeclidinium acts as a long-acting muscarinic antagonist, while vilanterol is a long-acting beta-agonist. Together, these medications work by relaxing and opening the airways in the lungs, making it easier to breathe. This combination is classified as a bronchodilator. Additional medications used in the study include Ventolin (containing salbutamol sulfate) and Flixotide (containing fluticasone propionate).
Summary
Currently, one clinical trial is actively recruiting patients with obstructive airways disorder who also have heart failure. This trial is being conducted in Spain and represents a focused investigation into how combination bronchodilator therapy might benefit patients with both lung and heart conditions. The study specifically targets individuals with moderate lung hyperinflation and mid-range heart function, examining whether improving breathing can also enhance heart performance during exercise. The use of exercise testing combined with advanced imaging techniques reflects a comprehensive approach to understanding the interaction between respiratory and cardiovascular function in this patient population.