AstraZeneca
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.
Chronic Obstructive Pulmonary Disease
Treatment A : Budesonide, Glycopyrronium, and Formoterol Fumarate
Treatment B: Budesonide and Formoterol Fumarate
Treatment C : Placebo
PHASE3
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: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
NOT YET RECRUITING
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Los Angeles, California, United States, 90095
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Tarzana, California, United States, 91356
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Torrance, California, United States, 90502
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Brooksville, Florida, United States, 34613
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Anderson, South Carolina, United States, 29621
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Greenville, South Carolina, United States, 29615
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Spartanburg, South Carolina, United States, 29303
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CABA, Argentina, 1426
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CABA, Argentina, C1280AEB
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Quilmes, Argentina, B1878FNR
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Edmonton, Alberta, Canada, Censure
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Kingston, Ontario, Canada, Kohl is a joyful
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Holy Foy, Quebec, Canada, G1V 4G5
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Guangzhou, China, 510163
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Nanchang, China, 330006
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Shenyang, China, 110001
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Zhengzhou, China, 450000
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Berlin, Germany, 12159
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Berlin, Germany, 14050
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Frankfurt, Germany, 60596
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Großhansdorf, Germany, 22927
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Hannover, Germany, 30449
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Heidelberg, Germany, 69115
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Lübeck, Germany, 23552
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Mainz, Germany, 55128
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Daegu, Korea, Republic of, 42415
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Seoul, Korea, Republic of, 02447
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Seoul, Korea, Republic of, 05030
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Benalmádena, Spain, 29630
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Madrid, Spain, 28007
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Santiago de Compostela, Spain, 15706
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Sevilla, Spain, 41013
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Leeds, United Kingdom, LS9 7TF
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Leicester, United Kingdom, LE1 5WW
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London, United Kingdom, SW3 6HP
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London, United Kingdom, W1T 6AH
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Manchester, United Kingdom, M23 9GP