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NCT06067828 | RECRUITING | Chronic Obstructive Pulmonary Disease


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).
Sponsor:

AstraZeneca

Brief 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.

Condition or disease

Chronic Obstructive Pulmonary Disease

Intervention/treatment

Treatment A : Budesonide, Glycopyrronium, and Formoterol Fumarate

Treatment B: Budesonide and Formoterol Fumarate

Treatment C : Placebo

Phase

PHASE3

Detailed 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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 180 participants
Masking : DOUBLE
Primary Purpose : TREATMENT
Official Title : A Double-Blind, Multicentre, Randomized, Three-Period, Three-Treatment, Cross-Over Study to Evaluate the Effect of BGF MDI, BFF MDI, and Placebo MDI on Exercise Parameters in Participants With COPD (ATHLOS)
Actual Study Start Date : 2023-10-24
Estimated Primary Completion Date : 2025-08-24
Estimated Study Completion Date : 2025-08-25

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 40 Years to 80 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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.

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).

Location Details

NCT06067828


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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


NOT YET RECRUITING

United States, California

Research Site

Los Angeles, California, United States, 90095

NOT YET RECRUITING

United States, California

Research Site

Tarzana, California, United States, 91356

RECRUITING

United States, California

Research Site

Torrance, California, United States, 90502

RECRUITING

United States, Florida

Research Site

Brooksville, Florida, United States, 34613

RECRUITING

United States, South Carolina

Research Site

Anderson, South Carolina, United States, 29621

RECRUITING

United States, South Carolina

Research Site

Greenville, South Carolina, United States, 29615

RECRUITING

United States, South Carolina

Research Site

Spartanburg, South Carolina, United States, 29303

WITHDRAWN

Argentina,

Research Site

CABA, Argentina, 1426

WITHDRAWN

Argentina,

Research Site

CABA, Argentina, C1280AEB

WITHDRAWN

Argentina,

Research Site

Quilmes, Argentina, B1878FNR

RECRUITING

Canada, Alberta

Research Site

Edmonton, Alberta, Canada, Censure

RECRUITING

Canada, Ontario

Research Site

Kingston, Ontario, Canada, Kohl is a joyful

RECRUITING

Canada, Quebec

Research Site

Holy Foy, Quebec, Canada, G1V 4G5

RECRUITING

China,

Research Site

Guangzhou, China, 510163

RECRUITING

China,

Research Site

Nanchang, China, 330006

RECRUITING

China,

Research Site

Shenyang, China, 110001

RECRUITING

China,

Research Site

Zhengzhou, China, 450000

RECRUITING

Germany,

Research Site

Berlin, Germany, 12159

RECRUITING

Germany,

Research Site

Berlin, Germany, 14050

RECRUITING

Germany,

Research Site

Frankfurt, Germany, 60596

RECRUITING

Germany,

Research Site

Großhansdorf, Germany, 22927

RECRUITING

Germany,

Research Site

Hannover, Germany, 30449

RECRUITING

Germany,

Research Site

Heidelberg, Germany, 69115

RECRUITING

Germany,

Research Site

Lübeck, Germany, 23552

RECRUITING

Germany,

Research Site

Mainz, Germany, 55128

RECRUITING

Korea, Republic of,

Research Site

Daegu, Korea, Republic of, 42415

RECRUITING

Korea, Republic of,

Research Site

Seoul, Korea, Republic of, 02447

RECRUITING

Korea, Republic of,

Research Site

Seoul, Korea, Republic of, 05030

RECRUITING

Spain,

Research Site

Benalmádena, Spain, 29630

RECRUITING

Spain,

Research Site

Madrid, Spain, 28007

NOT YET RECRUITING

Spain,

Research Site

Santiago de Compostela, Spain, 15706

NOT YET RECRUITING

Spain,

Research Site

Sevilla, Spain, 41013

WITHDRAWN

United Kingdom,

Research Site

Leeds, United Kingdom, LS9 7TF

RECRUITING

United Kingdom,

Research Site

Leicester, United Kingdom, LE1 5WW

RECRUITING

United Kingdom,

Research Site

London, United Kingdom, SW3 6HP

RECRUITING

United Kingdom,

Research Site

London, United Kingdom, W1T 6AH

RECRUITING

United Kingdom,

Research Site

Manchester, United Kingdom, M23 9GP

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