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New inhaler helps COPD patients breathe easier during exercise

NCT ID NCT06067828

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a triple-combination inhaler (BGF) in 171 adults with moderate-to-severe COPD. Participants received BGF, a dual-combination inhaler (BFF), or placebo in random order. The goal was to see if BGF improves breathing capacity and exercise endurance compared to the other treatments. Results may help guide better symptom management for COPD.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

171 people

The number who actually took part.

Started

Oct 2023

Finished

Jan 2026

Lead sponsor

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

40 to 80 years

Sex

Anyone

Healthy volunteers

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

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 male or female, 40 to 80 years of age inclusive, at the time of signing the informed consent. * Participant must have: * a diagnosis of COPD confirmed by a post-bronchodilator Forced expiratory volume (FEV1)/ Forced vital capacity (FVC) \< 0.7 at Visit 1 * a post-bronchodilator FEV1 ≥ 30% and \<80% predicted normal (moderate to severe COPD) at Visit 1. * a score of ≥ 2 on the modified Medical Research Council at Visit 1. * pre-bronchodilator FRC of \> 120% of predicted normal FRC values at Visit 1. * a constant work rate test endurance time of 3 to 8 minutes at Visit 2. * Participant must be on a stable dose of mono-or dual inhaled maintenance COPD treatment for at least 6 weeks. * Current or former smoker with a history of ≥ 10 pack-years of tobacco smoking * Body mass index \< 40 kg/m2. * Male and Female participants (not applicable for female participants with non-childbearing potential) and their partners must use an acceptable method of contraception. Exclusion Criteria: * A current diagnosis of asthma, asthma- COPD-overlap, or any other chronic respiratory disease other than COPD such as alpha-1 antitrypsin deficiency, active tuberculosis, lung cancer, lung fibrosis, sarcoidosis, interstitial lung disease and pulmonary hypertension. * Historical or current evidence of a clinically significant disease * Participants on oxygen therapy or that desaturate significantly (\<82%) during exercise. * Participants who are enrolled or entering a pulmonary rehabilitation program during the study. * Participants who have cancer that has not been in complete remission for at least 5 years. * Participants with a diagnosis of narrow-angle glaucoma that has not been adequately treated and/or change in vision that may be relevant, in the opinion of the investigator. * Participants with symptomatic prostatic hypertrophy or bladder neck obstruction/urinary retention that, in the opinion of the investigator, is clinically significant. * Participants who have a history of hypersensitivity to β2-agonists, budesonide or any other corticosteroid components, glycopyrronium or other muscarinic anticholinergics, or any component of the MDI or dry powder inhaler. * Participant with resting (5 minutes) oxygen saturation SaO2 in room air ≤ 85%. * A COPD exacerbation that requires hospitalization within 12 months prior to Visit 1 or a COPD exacerbation that requires systemic corticosteroids or antibiotics within 4 months of Visit 1. * Participants with contraindications to cardiopulmonary exercise testing (CPET). * Participants who have had a respiratory tract infection within 8 weeks prior to Visit 1 and/or during the screening period. * Participants with lung lobectomy, lung volume reduction or lung transplantation. * Unable to withhold short-acting bronchodilators for 6 hours prior to lung function testing at each study visit. * Known history of drug or alcohol abuse within 12 months. * Any regular recreational use of marijuana in the 12 months.

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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

  • Research Site

    Los Angeles, California, 90095, United States

  • Research Site

    Tarzana, California, 91356, United States

  • Research Site

    Torrance, California, 90502, United States

  • Research Site

    Brooksville, Florida, 34613, United States

  • Research Site

    Anderson, South Carolina, 29621, United States

  • Research Site

    Greenville, South Carolina, 29615, United States

  • Research Site

    Spartanburg, South Carolina, 29303, United States

  • Research Site

    Edmonton, Alberta, T6G 2B7, Canada

  • Research Site

    Kingston, Ontario, K7L 2V7, Canada

  • Research Site

    Sainte-Foy, Quebec, G1V 4G5, Canada

  • Research Site

    Guangzhou, 510163, China

  • Research Site

    Nanchang, 330006, China

  • Research Site

    Shenyang, 110001, China

  • Research Site

    Zhengzhou, 450000, China

  • Research Site

    Berlin, 12159, Germany

  • Research Site

    Berlin, 14050, Germany

  • Research Site

    Frankfurt, 60596, Germany

  • Research Site

    Großhansdorf, 22927, Germany

  • Research Site

    Hanover, 30449, Germany

  • Research Site

    Heidelberg, 69115, Germany

  • Research Site

    Lübeck, 23552, Germany

  • Research Site

    Mainz, 55128, Germany

  • Research Site

    Daegu, 42415, South Korea

  • Research Site

    Seoul, 02447, South Korea

  • Research Site

    Seoul, 05030, South Korea

  • Research Site

    Benalmádena, 29630, Spain

  • Research Site

    Madrid, 28007, Spain

  • Research Site

    Santiago de Compostela, 15706, Spain

  • Research Site

    Seville, 41013, Spain

  • Research Site

    Leicester, LE1 5WW, United Kingdom

  • Research Site

    London, SW3 6HP, United Kingdom

  • Research Site

    London, W1T 6AH, United Kingdom

  • Research Site

    Manchester, M23 9GP, United Kingdom

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