Efficacy and Safety of Glycopyrronium/Formoterol Fumarate Fixed-dose Combination Relative to Umeclidinium/Vilanterol Fixed-dose Combination Over 24 Weeks in Patients With Moderate to Very Severe Chronic Obstructive Pulmonary Disease
NCT ID: NCT03162055
Last Updated: 2019-05-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1119 participants
INTERVENTIONAL
2017-05-25
2018-05-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Experimental
glycopyrronium/formoterol fumarate 7.2/4.8 μg per actuation, twice daily
Glycopyrronium/Formoterol Fumarate
Metered dose inhaler (MDI), contains glycopyrronium/formoterol fumarate fixed-dose combination 7.2/4.8 μg per actuation
Active comparator
umeclidinium/vilanterol 62.5/ 25μg per inhalation, once daily
umeclidinium/vilanterol
Dry powder inhaler (DPI), Each metered dose contains umeclidinium/vilanterol 62.5/ 25μg fixed-dose combination per inhalation
Interventions
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Glycopyrronium/Formoterol Fumarate
Metered dose inhaler (MDI), contains glycopyrronium/formoterol fumarate fixed-dose combination 7.2/4.8 μg per actuation
umeclidinium/vilanterol
Dry powder inhaler (DPI), Each metered dose contains umeclidinium/vilanterol 62.5/ 25μg fixed-dose combination per inhalation
Eligibility Criteria
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Inclusion Criteria
* Current or former smoker with a history of at least 10 pack-years of cigarette smoking
* Current clinical diagnosis of COPD, with COPD symptoms \> 1 year prior to screening, as defined by GOLD criteria or other current guidelines
* COPD Severity defined by FEV1/FVC ratio \<0.70 and FEV1 \<80% of predicted normal value at screening and at randomisation
* COPD treatment with rescue medication only, or stable dose of maintenance monotherapy (LAMA, LABA or ICS), or stable dose of double maintenance therapy (LAMA/LABA or ICS/LABA), for one month prior to screening
* COPD Assessment Test (CAT) score ≥10 at randomisation
* Documentation of a chest x-ray (as per local practice) or computed tomography (CT) within 6 months prior to screening, with no clinically significant pulmonary abnormalities other than related to COPD
Exclusion Criteria
* Current diagnosis of asthma
* Alpha-1 Antitrypsin Deficiency as the cause of COPD
* Other respiratory disorders and conditions as listed in the protocol
* Severe COPD exacerbation (resulting in hospitalisation) not resolved within 8 weeks prior to screening, or moderate exacerbation not resolved within 4 weeks, or during screening
* Pneumonia or lower respiratory tract infection that required antibiotics within 8 weeks prior to screening, or during screening.
* Significant diseases or conditions other than COPD which may put the patient at risk, or influence the results of the study or the patient's ability to participate, including cardiac disease, advanced renal disease, and cancer that has not been in complete remission for at least 5 years.
* Patients who have needed additions or alterations to their usual maintenance therapy for COPD due to worsening symptoms within 1 month prior to and during screening
* Treatment with depot corticosteroids within 6 weeks, or other systemic corticosteroids within 4 weeks, prior to screening. (Patients maintained on an equivalent of 5 mg prednisone per day for at least 3 months prior to screening are allowed.)
40 Years
95 Years
ALL
No
Sponsors
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Parexel International Ltd
UNKNOWN
Cognizant Technology Solution
UNKNOWN
CISCRP
INDUSTRY
eResearchTechnology
INDUSTRY
QuintilesIMS Limited
UNKNOWN
Corporate Translations Inc
UNKNOWN
AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
Tempe, Arizona, United States
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Escondido, California, United States
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Sacramento, California, United States
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Hollywood, Florida, United States
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Lawrenceville, Georgia, United States
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Rincon, Georgia, United States
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Farmington Hills, Michigan, United States
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The Bronx, New York, United States
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Gastonia, North Carolina, United States
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Dublin, Ohio, United States
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Pittsburgh, Pennsylvania, United States
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Greenville, South Carolina, United States
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Spartanburg, South Carolina, United States
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Sherman, Texas, United States
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Tomball, Texas, United States
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Dupnitsa, , Bulgaria
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Dupnitsa, , Bulgaria
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Haskovo, , Bulgaria
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Kozloduy, , Bulgaria
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Pazardzhik, , Bulgaria
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Petrich, , Bulgaria
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Pleven, , Bulgaria
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Plovdiv, , Bulgaria
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Razlog, , Bulgaria
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Rousse, , Bulgaria
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Sliven, , Bulgaria
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Smolyan, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Stara Zagora, , Bulgaria
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Varna, , Bulgaria
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Vidin, , Bulgaria
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Sherwood Park, Alberta, Canada
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Winnipeg, Manitoba, Canada
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Truro, Nova Scotia, Canada
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Burlington, Ontario, Canada
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Burlington, Ontario, Canada
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Etobicoke, Ontario, Canada
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Windsor, Ontario, Canada
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Windsor, Ontario, Canada
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Gatineau, Quebec, Canada
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Lévis, Quebec, Canada
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Québec, Quebec, Canada
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Québec, Quebec, Canada
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Québec, Quebec, Canada
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Saint-Charles-Borromée, Quebec, Canada
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Besançon, , France
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Brest, , France
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Lyon, , France
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Montpellier, , France
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Nantes, , France
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Pessac, , France
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Poitiers, , France
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Reims, , France
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Balassagyarmat, , Hungary
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Budapest, , Hungary
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Debrecen, , Hungary
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Debrecen, , Hungary
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Farkasgyepü, , Hungary
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Hajdúnánás, , Hungary
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Komárom, , Hungary
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Komló, , Hungary
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Miskolc, , Hungary
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Püspökladány, , Hungary
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Siófok, , Hungary
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Szeged, , Hungary
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Szombathely, , Hungary
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Vásárosnamény, , Hungary
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Barnaul, , Russia
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Barnaul, , Russia
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Chelyabinsk, , Russia
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Izhevsk, , Russia
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Moscow, , Russia
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Novosibirsk, , Russia
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Penza, , Russia
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Penza, , Russia
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Ryazan, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saratov, , Russia
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Smolensk, , Russia
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Tomsk, , Russia
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Ulyanovsk, , Russia
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Yekaterinburg, , Russia
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Chernivtsi, , Ukraine
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Chernivtsi, , Ukraine
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Ivano-Frankivsk, , Ukraine
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Kharkiv, , Ukraine
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Kharkiv, , Ukraine
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Kharkiv, , Ukraine
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Kyiv, , Ukraine
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Kyiv, , Ukraine
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Lutsk, , Ukraine
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Lviv, , Ukraine
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Odesa, , Ukraine
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Poltava, , Ukraine
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Vinnytsia, , Ukraine
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Vinnytsia, , Ukraine
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Zaporizhzhia, , Ukraine
Countries
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References
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Maltais F, Ferguson GT, Feldman GJ, Deslee G, Bourdin A, Fjallbrant H, Siwek-Posluszna A, Jenkins MA, Martin UJ. A Randomized, Double-Blind, Double-Dummy Study of Glycopyrrolate/Formoterol Fumarate Metered Dose Inhaler Relative to Umeclidinium/Vilanterol Dry Powder Inhaler in COPD. Adv Ther. 2019 Sep;36(9):2434-2449. doi: 10.1007/s12325-019-01015-3. Epub 2019 Jul 2.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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D5970C00002
Identifier Type: -
Identifier Source: org_study_id
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