New study shows triple inhaler helps COPD patients breathe easier
NCT ID NCT05535972
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at how well a single inhaler containing three medicines (Trelegy Ellipta) works for people with chronic obstructive pulmonary disease (COPD) in real-world settings. Over 12 weeks, 463 adults aged 40 and older with ongoing COPD symptoms used the inhaler. Researchers measured changes in health status, shortness of breath, and lung function to see if the treatment improved daily life.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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463 people
The number who actually took part.
- Started
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Oct 2022
- Finished
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Sep 2023
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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40 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Participant must be 40 years or above of age inclusive, at the time of signing the informed consent. * Participants with a documented physician diagnosis of COPD. * CAT greater than or equal to (≥) 10. * Existing COPD Maintenance Treatment. Participants currently receiving one of the maintenance therapies given below who have been prescribed it continually for at least 12 weeks prior to screening (Visit 1): Inhaled Corticosteroids/ Long-Acting Beta-2-Agonists (ICS/LABA) (single or multiple inhalers); Long-Acting Muscarinic Antagonist (LAMA)/LABA (single or multiple inhalers); Free combination of inhaled corticosteroids (ICS), LAMA, LABA. * Current or former cigarette smokers with a history of cigarette smoking history ≥10 pack-years at screening. * Trelegy is prescribed under the discretion of clinical physicians with medical records providing documentation of a Trelegy prescription in daily practice. * Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Exclusion Criteria: * Women who are pregnant or lactating or are planning on becoming pregnant during the study. * Prescribed with Trelegy within one year prior to screening (Visit 1). * Participants who, in the opinion of the treating investigator, are chronic users of oral corticosteroids for respiratory or other indications (if unsure discuss with the medical monitor prior to screening). Chronic use is defined as more than 14 days continuous use during the 12 weeks prior to Visit 1. * Participants with any life-threatening condition i.e. low probability, in the opinion of the investigator, of 3-month survival due to severity of COPD or comorbid condition. * Participants with unstable COPD. Participants with resolution of an exacerbation less than 2 weeks prior to Visit 1. Participants may be rescreened 2 weeks after resolution of exacerbation (exacerbation is defined as: requiring treatment with antibiotics and/or systemic steroids or hospitalization; resolution is defined as: 2 weeks after all symptoms have resolved and any medicines to treat the exacerbation have finished). * Participants who need more than 3 liter per minute (L/min) supplemental oxygen at rest at screening. * Other diseases/abnormalities: Participants with historical or current evidence of uncontrolled or clinically significant disease. Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the participant at risk through participation, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study. * Participant received any investigational drug in other clinical trial within four weeks or 5 half-lives prior to this study whichever is longer. * Any conditions or illnesses listed in the section of contraindications in the Summary of Product Characteristics (SmPC) of Trelegy, i.e., hypersensitivity to the active substances of TRELEGY ELLIPTA. * Participants with known COVID-19 positive contacts within the past 14 days. * Inability to read: In the opinion of the Investigator, any participant who is unable to read and/or would not be able to complete study related materials.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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GSK Investigational Site
Dongguan, 523326, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.