A Study to Evaluate the Effect of Budesonide, Glycopyrronium, Formoterol Fumarate (BGF) Metered Dose Inhaler (MDI), Budesonide and Formoterol Fumarate (BFF) MDI and Placebo MDI on Exercise Parameters in Participants With Chronic Obstructive Pulmonary Disease (COPD).

Last updated: March 3, 2025
Sponsor: AstraZeneca
Overall Status: Active - Recruiting

Phase

3

Condition

N/A

Treatment

Treatment C : Placebo

Treatment A : Budesonide, Glycopyrronium, and Formoterol Fumarate

Treatment B: Budesonide and Formoterol Fumarate

Clinical Study ID

NCT06067828
D5988C00001
  • Ages 40-80
  • All Genders

Study Summary

This study will investigate the effect of Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF) metered dose inhaler (MDI) compared with Placebo MDI, and Budesonide and Formoterol Fumarate (BFF) MDI on isotime inspiratory capacity (IC) and exercise endurance time.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participant must be male or female, 40 to 80 years of age inclusive, at the time ofsigning 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 severeCOPD) 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 COPDtreatment 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 withnon-childbearing potential) and their partners must use an acceptable method ofcontraception.

Exclusion

Exclusion Criteria:

  • A current diagnosis of asthma, asthma- COPD-overlap, or any other chronicrespiratory disease other than COPD such as alpha-1 antitrypsin deficiency, activetuberculosis, lung cancer, lung fibrosis, sarcoidosis, interstitial lung disease andpulmonary hypertension.

  • Historical or current evidence of a clinically significant disease

  • Participants on oxygen therapy or that desaturate significantly (<82%) duringexercise.

  • Participants who are enrolled or entering a pulmonary rehabilitation program duringthe study.

  • Participants who have cancer that has not been in complete remission for at least 5years.

  • Participants with a diagnosis of narrow-angle glaucoma that has not been adequatelytreated and/or change in vision that may be relevant, in the opinion of theinvestigator.

  • Participants with symptomatic prostatic hypertrophy or bladder neckobstruction/urinary retention that, in the opinion of the investigator, isclinically significant.

  • Participants who have a history of hypersensitivity to β2-agonists, budesonide orany other corticosteroid components, glycopyrronium or other muscarinicanticholinergics, 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 1or 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 toVisit 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 functiontesting at each study visit.

  • Known history of drug or alcohol abuse within 12 months.

  • Any regular recreational use of marijuana in the 12 months.

Study Design

Total Participants: 180
Treatment Group(s): 3
Primary Treatment: Treatment C : Placebo
Phase: 3
Study Start date:
October 24, 2023
Estimated Completion Date:
August 25, 2025

Study Description

This is a multicenter, three-treatment, three-period, cross-over study to assess the effect of BGF MDI vs Placebo MDI and BFF MDI in participants with COPD who have exertional breathlessness despite treatment with mono or dual COPD maintenance therapy.

Eligible participants will be randomized equally (1:1:1:1:1:1) to 1 of 6 treatment sequences. The total duration of the study for each participant will be up to 14 weeks.

Connect with a study center

  • Research Site

    Caba, C1280AEB
    Argentina

    Site Not Available

  • Research Site

    Quilmes, B1878FNR
    Argentina

    Site Not Available

  • Research Site

    Edmonton, Alberta T6G 2B7
    Canada

    Active - Recruiting

  • Research Site

    Kingston, Ontario K7L 2V7
    Canada

    Active - Recruiting

  • Research Site

    Sainte Foy, Quebec G1V 4G5
    Canada

    Active - Recruiting

  • Research Site

    Guangzhou, 510163
    China

    Active - Recruiting

  • Research Site

    Nanchang, 330006
    China

    Active - Recruiting

  • Research Site

    Shenyang, 110001
    China

    Active - Recruiting

  • Research Site

    Zhengzhou, 450000
    China

    Active - Recruiting

  • Research Site

    Berlin, 12159
    Germany

    Active - Recruiting

  • Research Site

    Frankfurt, 60596
    Germany

    Active - Recruiting

  • Research Site

    Großhansdorf, 22927
    Germany

    Active - Recruiting

  • Research Site

    Hannover, 30449
    Germany

    Active - Recruiting

  • Research Site

    Heidelberg, 69115
    Germany

    Active - Recruiting

  • Research Site

    Lübeck, 23552
    Germany

    Active - Recruiting

  • Research Site

    Mainz, 55128
    Germany

    Active - Recruiting

  • Research Site

    Daegu, 42415
    Korea, Republic of

    Active - Recruiting

  • Research Site

    Seoul, 05030
    Korea, Republic of

    Active - Recruiting

  • Research Site

    Benalmádena, 29630
    Spain

    Active - Recruiting

  • Research Site

    Madrid, 28007
    Spain

    Active - Recruiting

  • Research Site

    Santiago de Compostela, 15706
    Spain

    Site Not Available

  • Research Site

    Sevilla, 41013
    Spain

    Site Not Available

  • Research Site

    Leeds, LS9 7TF
    United Kingdom

    Site Not Available

  • Research Site

    Leicester, LE1 5WW
    United Kingdom

    Active - Recruiting

  • Research Site

    London, W1T 6AH
    United Kingdom

    Active - Recruiting

  • Research Site

    Manchester, M23 9GP
    United Kingdom

    Active - Recruiting

  • Research Site

    Los Angeles, California 90095
    United States

    Site Not Available

  • Research Site

    Tarzana, California 91356
    United States

    Site Not Available

  • Research Site

    Torrance, California 90502
    United States

    Active - Recruiting

  • Research Site

    Brooksville, Florida 34613
    United States

    Active - Recruiting

  • Research Site

    Anderson, South Carolina 29621
    United States

    Active - Recruiting

  • Research Site

    Greenville, South Carolina 29615
    United States

    Active - Recruiting

  • Research Site

    Spartanburg, South Carolina 29303
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.