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, 1426
ArgentinaSite Not Available
Research Site
Caba, C1280AEB
ArgentinaSite Not Available
Research Site
Ciudad de Buenos Aires, C1280AEB
ArgentinaSite Not Available
Research Site
Quilmes, B1878FNR
ArgentinaSite Not Available
Research Site
Quilmes 3429652, B1878FNR
ArgentinaSite Not Available
Research Site
Edmonton, Alberta T6G 2B7
CanadaSite Not Available
Research Site
Edmonton 5946768, Alberta 5883102 T6G 2B7
CanadaSite Not Available
Research Site
Kingston, Ontario K7L 2V7
CanadaSite Not Available
Research Site
Kingston 5992500, Ontario 6093943 K7L 2V7
CanadaSite Not Available
Research Site
Sainte Foy, Quebec G1V 4G5
CanadaSite Not Available
Research Site
Sainte-Foy, Quebec G1V 4G5
CanadaSite Not Available
Research Site
Sainte-Foy 6325488, Quebec 6115047 G1V 4G5
CanadaSite Not Available
Research Site
Guangzhou, 510163
ChinaSite Not Available
Research Site
Guangzhou 1809858, 510163
ChinaSite Not Available
Research Site
Nanchang, 330006
ChinaSite Not Available
Research Site
Nanchang 1800163, 330006
ChinaSite Not Available
Research Site
Shenyang, 110001
ChinaSite Not Available
Research Site
Shenyang 2034937, 110001
ChinaSite Not Available
Research Site
Zhengzhou, 450000
ChinaSite Not Available
Research Site
Zhengzhou 1784658, 450000
ChinaSite Not Available
Research Site
Berlin, 12159
GermanySite Not Available
Research Site
Berlin 2950159, 14050
GermanySite Not Available
Research Site
Frankfurt, 60596
GermanySite Not Available
Research Site
Frankfurt 2925536, 60596
GermanySite Not Available
Research Site
Großhansdorf, 22927
GermanySite Not Available
Research Site
Großhansdorf 2915556, 22927
GermanySite Not Available
Research Site
Hannover, 30449
GermanySite Not Available
Research Site
Hanover, 30449
GermanySite Not Available
Research Site
Hanover 2910831, 30449
GermanySite Not Available
Research Site
Heidelberg, 69115
GermanySite Not Available
Research Site
Heidelberg 2907911, 69115
GermanySite Not Available
Research Site
Lübeck, 23552
GermanySite Not Available
Research Site
Lübeck 2875601, 23552
GermanySite Not Available
Research Site
Mainz, 55128
GermanySite Not Available
Research Site
Mainz 2874225, 55128
GermanySite Not Available
Research Site
Daegu, 42415
Korea, Republic ofSite Not Available
Research Site
Seoul, 02447
Korea, Republic ofSite Not Available
Research Site
Daegu, 42415
South KoreaSite Not Available
Research Site
Daegu 1835329, 42415
South KoreaSite Not Available
Research Site
Seoul, 02447
South KoreaSite Not Available
Research Site
Seoul 1835848, 05030
South KoreaSite Not Available
Research Site
Benalmádena, 29630
SpainSite Not Available
Research Site
Benalmádena 2521139, 29630
SpainSite Not Available
Research Site
Madrid, 28007
SpainSite Not Available
Research Site
Madrid 3117735, 28007
SpainSite Not Available
Research Site
Santiago de Compostela, 15706
SpainSite Not Available
Research Site
Santiago de Compostela 3109642, 15706
SpainSite Not Available
Research Site
Sevilla, 41013
SpainSite Not Available
Research Site
Seville, 41013
SpainSite Not Available
Research Site
Seville 2510911, 41013
SpainSite Not Available
Research Site
Leeds, LS9 7TF
United KingdomSite Not Available
Research Site
Leeds 2644688, LS9 7TF
United KingdomSite Not Available
Research Site
Leicester, LE1 5WW
United KingdomSite Not Available
Research Site
Leicester 2644668, LE1 5WW
United KingdomSite Not Available
Research Site
London, W1T 6AH
United KingdomSite Not Available
Research Site
London 2643743, SW3 6HP
United KingdomSite Not Available
Research Site
Manchester, M23 9GP
United KingdomSite Not Available
Research Site
Manchester 2643123, M23 9GP
United KingdomSite Not Available
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 StatesSite Not Available
Research Site
Los Angeles 5368361, California 5332921 90095
United StatesSite Not Available
Research Site
Tarzana 5401143, California 5332921 91356
United StatesSite Not Available
Research Site
Torrance 5403022, California 5332921 90502
United StatesSite Not Available
Research Site
Brooksville, Florida 34613
United StatesSite Not Available
Research Site
Brooksville 4148986, Florida 4155751 34613
United StatesSite Not Available
Research Site
Anderson, South Carolina 29621
United StatesSite Not Available
Research Site
Greenville, South Carolina 29615
United StatesSite Not Available
Research Site
Spartanburg, South Carolina 29303
United StatesSite Not Available
Research Site
Anderson 4569298, South Carolina 4597040 29621
United StatesSite Not Available
Research Site
Greenville 4580543, South Carolina 4597040 29615
United StatesSite Not Available
Research Site
Spartanburg 4597200, South Carolina 4597040 29303
United StatesSite Not Available

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