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
AERISTO
A Randomised, Double-Blind, Double-Dummy, Multicentre, Parallel Group Study to Assess the 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 (AERISTO)
1 other identifier
interventional
1,119
7 countries
107
Brief Summary
This is a phase IIIb randomised, double-blind, double-dummy, multicentre, parallel group, 24 week study to assess the efficacy and safety of Glycopyrronium/Formoterol Fumarate (GFF) fixed-dose combination 7.2/4.8 μg 2 inhalations twice daily compared to Umeclidinium/Vilanterol (UV) 62.5/25 μg fixed-dose combination 1 inhalation once daily in Patients with moderate to very severe COPD.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2017
Shorter than P25 for phase_3
107 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 19, 2017
CompletedFirst Posted
Study publicly available on registry
May 22, 2017
CompletedStudy Start
First participant enrolled
May 25, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 4, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 4, 2018
CompletedResults Posted
Study results publicly available
May 22, 2019
CompletedMay 22, 2019
April 1, 2019
11 months
May 19, 2017
April 30, 2019
April 30, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Mean Change From Baseline in Morning Pre-dose Trough Forced Expiratory Volume in 1 Second (FEV1) Over 24 Weeks
To assess the effects of GFF relative to UV on lung function as measured by change from baseline in morning pre-dose trough FEV1 is defined as the average of the -60 and -30 minute pre-dose values at each visit minus baseline using spirometry. Baseline is defined as the mean of the non-missing -60 and -30 minute values obtained prior to dosing at randomization (Day 1). BR a/s = bronchodilator responsiveness to albuterol/salbutamol.
From Baseline (Day 1) up to 24 weeks
Mean Peak Change From Baseline in FEV1 Within 2 Hours Post-dosing Over 24 Weeks in PP Analysis Set Population
To assess the effects of GFF relative to UV on lung function in PP analysis set population as measured by peak change from baseline in FEV1 is defined as the maximum of the FEV1 assessments within the 2 hours post-dosing time windows at each visit minus baseline using spirometry. Baseline is defined as the mean of the non-missing -60 and -30 minute values obtained prior to dosing at randomization (Day 1).
From Baseline (Day 1) up to 24 weeks
Mean Peak Change From Baseline in FEV1 Within 2 Hours Post-dosing Over 24 Weeks in FAS Population
To assess the effects of GFF relative to UV on lung function in FAS population as measured by peak change from baseline in FEV1 is defined as the maximum of the FEV1 assessments within the 2 hours post-dosing time windows at each visit minus baseline using spirometry. Baseline is defined as the mean of the non-missing -60 and -30 minute values obtained prior to dosing at randomization (Day 1).
From Baseline (Day 1) up to 24 weeks
Secondary Outcomes (4)
Percentage of Participants With Increase of FEV1 of >=100 mL From Baseline at 5 Minutes Post-dosing on Day 1
5 minutes post-dose on Day 1
Mean Peak Change From Baseline in Inspiratory Capacity (IC) Within 2 Hours Post-dosing Over 24 Weeks
From Baseline (Day 1) up to 24 weeks
Mean Transition Dyspnea Index (TDI) Focal Score Over 24 Weeks
From Baseline (Day -7 or 1) up to 24 weeks
Mean Change From Baseline in Early Morning Symptoms of COPD Instrument (EMSCI) Over 24 Weeks
From Baseline (Day -7) up to 24 weeks
Other Outcomes (3)
Mean Change From Baseline in Night-Time Symptoms of COPD Instrument (NiSCI) Over 24 Weeks
From Baseline (Day -7) up to 24 weeks
Mean Change From Baseline in Daily Rescue (Albuterol/Salbutamol MDI) Use Over 24 Weeks
From Baseline (Day -7) up to 24 weeks
Mean Change From Baseline in COPD Assessment Test (CAT) Score Over 24 Weeks
From Baseline (Day -7 or 1) up to 24 weeks
Study Arms (2)
Experimental
EXPERIMENTALglycopyrronium/formoterol fumarate 7.2/4.8 μg per actuation, twice daily
Active comparator
ACTIVE COMPARATORumeclidinium/vilanterol 62.5/ 25μg per inhalation, once daily
Interventions
Metered dose inhaler (MDI), contains glycopyrronium/formoterol fumarate fixed-dose combination 7.2/4.8 μg per actuation
Dry powder inhaler (DPI), Each metered dose contains umeclidinium/vilanterol 62.5/ 25μg fixed-dose combination per inhalation
Eligibility Criteria
You may qualify if:
- Age 40-95 years at screening
- 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
You may not qualify if:
- Respiratory disease other than COPD, including:
- 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.)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Parexel International Ltdcollaborator
- Cognizant Technology Solutioncollaborator
- CISCRPcollaborator
- eResearchTechnologycollaborator
- QuintilesIMS Limitedcollaborator
- Corporate Translations Inccollaborator
Study Sites (107)
Research Site
Tempe, Arizona, 85283, United States
Research Site
Escondido, California, 92025, United States
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Sacramento, California, 95821, United States
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Hollywood, Florida, 33021, United States
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Lawrenceville, Georgia, 30046, United States
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Rincon, Georgia, 31326, United States
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Farmington Hills, Michigan, 48336, United States
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The Bronx, New York, 10455, United States
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Gastonia, North Carolina, 28054, United States
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Dublin, Ohio, 43016, United States
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Pittsburgh, Pennsylvania, 15243, United States
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Greenville, South Carolina, 29615, United States
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Spartanburg, South Carolina, 29303, United States
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Sherman, Texas, 75092, United States
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Tomball, Texas, 77375, United States
Research Site
Dupnitsa, 2600, Bulgaria
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Dupnitsa, 2602, Bulgaria
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Haskovo, 6305, Bulgaria
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Kozloduy, 3320, Bulgaria
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Pazardzhik, 4400, Bulgaria
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Petrich, 2850, Bulgaria
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Pleven, 5800, Bulgaria
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Plovdiv, 4002, Bulgaria
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Razlog, 2760, Bulgaria
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Rousse, 7002, Bulgaria
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Sliven, 8800, Bulgaria
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Smolyan, 4700, Bulgaria
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Sofia, 1002, Bulgaria
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Sofia, 1233, Bulgaria
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Sofia, 1407, Bulgaria
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Sofia, 1408, Bulgaria
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Sofia, 1618, Bulgaria
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Stara Zagora, 6000, Bulgaria
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Varna, 9000, Bulgaria
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Vidin, 3700, Bulgaria
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Sherwood Park, Alberta, T8L 0N2, Canada
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Winnipeg, Manitoba, R2V 4W3, Canada
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Truro, Nova Scotia, B2N 1L2, Canada
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Burlington, Ontario, L7M 4Y1, Canada
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Burlington, Ontario, L7N 3V2, Canada
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Etobicoke, Ontario, M9W 4L6, Canada
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Windsor, Ontario, N8X 1T3, Canada
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Windsor, Ontario, N8X-5A6, Canada
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Gatineau, Quebec, J8Y 6S8, Canada
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Lévis, Quebec, G6W 0M5, Canada
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Québec, Quebec, G1G 3Y8, Canada
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Québec, Quebec, G1V 4G5, Canada
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Québec, Quebec, G3K 2P8, Canada
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Saint-Charles-Borromée, Quebec, J6E 2B4, Canada
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Besançon, 25030, France
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Brest, 29609, France
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Lyon, 69317, France
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Montpellier, 34295, France
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Nantes, 44277, France
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Pessac, 33604, France
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Poitiers, 86021, France
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Reims, 51092, France
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Balassagyarmat, 2660, Hungary
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Budapest, 1135, Hungary
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Debrecen, 4032, Hungary
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Debrecen, H-4031, Hungary
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Farkasgyepü, 8582, Hungary
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Hajdúnánás, 4080, Hungary
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Komárom, 2900, Hungary
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Komló, 7300, Hungary
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Miskolc, 3529, Hungary
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Püspökladány, 4150, Hungary
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Siófok, 8600, Hungary
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Szeged, H-6722, Hungary
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Szombathely, 9700, Hungary
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Vásárosnamény, 4800, Hungary
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Barnaul, 656038, Russia
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Barnaul, 656045, Russia
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Chelyabinsk, 454021, Russia
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Izhevsk, 426035, Russia
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Moscow, 109544, Russia
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Novosibirsk, 630051, Russia
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Penza, 440026, Russia
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Penza, 440067, Russia
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Ryazan, 390005, Russia
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Saint Petersburg, 191015, Russia
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Saint Petersburg, 191180, Russia
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Saint Petersburg, 194291, Russia
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Saint Petersburg, 196084, Russia
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Saint Petersburg, 197022, Russia
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Saint Petersburg, 197342, Russia
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Saint Petersburg, 198260, Russia
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Saratov, 410012, Russia
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Smolensk, 214006, Russia
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Tomsk, 634050, Russia
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Ulyanovsk, 432009, Russia
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Yekaterinburg, 620028, Russia
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Chernivtsi, 58000, Ukraine
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Chernivtsi, 58001, Ukraine
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Ivano-Frankivsk, 76012, Ukraine
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Kharkiv, 61002, Ukraine
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Kharkiv, 61035, Ukraine
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Kharkiv, 61058, Ukraine
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Kyiv, 03680, Ukraine
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Kyiv, 04107, Ukraine
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Lutsk, 43000, Ukraine
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Lviv, 79066, Ukraine
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Odesa, 65025, Ukraine
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Poltava, 36040, Ukraine
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Vinnytsia, 21001, Ukraine
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Vinnytsia, 21029, Ukraine
Research Site
Zaporizhzhia, 69096, Ukraine
Related Publications (1)
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.
PMID: 31267366DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Vice President, Inhalation and Oral Respiratory
- Organization
- AstraZeneca
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 19, 2017
First Posted
May 22, 2017
Study Start
May 25, 2017
Primary Completion
May 4, 2018
Study Completion
May 4, 2018
Last Updated
May 22, 2019
Results First Posted
May 22, 2019
Record last verified: 2019-04