Phase
Condition
N/ATreatment
Treatment C : Placebo
Treatment A : Budesonide, Glycopyrronium, and Formoterol Fumarate
Treatment B: Budesonide and Formoterol Fumarate
Clinical Study ID
Ages 40-80 All Genders
Study Summary
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
Study Description
Connect with a study center
Research Site
Caba, C1280AEB
ArgentinaSite Not Available
Research Site
Quilmes, B1878FNR
ArgentinaSite Not Available
Research Site
Edmonton, Alberta T6G 2B7
CanadaActive - Recruiting
Research Site
Kingston, Ontario K7L 2V7
CanadaActive - Recruiting
Research Site
Sainte Foy, Quebec G1V 4G5
CanadaActive - Recruiting
Research Site
Guangzhou, 510163
ChinaActive - Recruiting
Research Site
Nanchang, 330006
ChinaActive - Recruiting
Research Site
Shenyang, 110001
ChinaActive - Recruiting
Research Site
Zhengzhou, 450000
ChinaActive - Recruiting
Research Site
Berlin, 12159
GermanyActive - Recruiting
Research Site
Frankfurt, 60596
GermanyActive - Recruiting
Research Site
Großhansdorf, 22927
GermanyActive - Recruiting
Research Site
Hannover, 30449
GermanyActive - Recruiting
Research Site
Heidelberg, 69115
GermanyActive - Recruiting
Research Site
Lübeck, 23552
GermanyActive - Recruiting
Research Site
Mainz, 55128
GermanyActive - Recruiting
Research Site
Daegu, 42415
Korea, Republic ofActive - Recruiting
Research Site
Seoul, 05030
Korea, Republic ofActive - Recruiting
Research Site
Benalmádena, 29630
SpainActive - Recruiting
Research Site
Madrid, 28007
SpainActive - Recruiting
Research Site
Santiago de Compostela, 15706
SpainSite Not Available
Research Site
Sevilla, 41013
SpainSite Not Available
Research Site
Leeds, LS9 7TF
United KingdomSite Not Available
Research Site
Leicester, LE1 5WW
United KingdomActive - Recruiting
Research Site
London, W1T 6AH
United KingdomActive - Recruiting
Research Site
Manchester, M23 9GP
United KingdomActive - Recruiting
Research Site
Los Angeles, California 90095
United StatesSite Not Available
Research Site
Tarzana, California 91356
United StatesSite Not Available
Research Site
Torrance, California 90502
United StatesActive - Recruiting
Research Site
Brooksville, Florida 34613
United StatesActive - Recruiting
Research Site
Anderson, South Carolina 29621
United StatesActive - Recruiting
Research Site
Greenville, South Carolina 29615
United StatesActive - Recruiting
Research Site
Spartanburg, South Carolina 29303
United StatesActive - Recruiting
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