Clinical trial NCT03162055: 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
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease COPD
Keywords: COPD
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Parexel International Ltd
name: Cognizant Technology Solution
name: CISCRP
name: eResearchTechnology
name: QuintilesIMS Limited
name: Corporate Translations Inc
First posted: 2017-05-22
Enrollment: 1119
Sex: ALL
Minimum age (years): 40
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion criteria:

* 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

Exclusion criteria:

* 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.)

Primary outcomes:
measure: Mean Change From Baseline in Morning Pre-dose Trough Forced Expiratory Volume in 1 Second (FEV1) Over 24 Weeks
timeFrame: From Baseline (Day 1) up to 24 weeks
measure: Mean Peak Change From Baseline in FEV1 Within 2 Hours Post-dosing Over 24 Weeks in PP Analysis Set Population
timeFrame: From Baseline (Day 1) up to 24 weeks
measure: Mean Peak Change From Baseline in FEV1 Within 2 Hours Post-dosing Over 24 Weeks in FAS Population
timeFrame: From Baseline (Day 1) up to 24 weeks
Secondary outcomes:
measure: Percentage of Participants With Increase of FEV1 of >=100 mL From Baseline at 5 Minutes Post-dosing on Day 1
timeFrame: 5 minutes post-dose on Day 1
measure: Mean Peak Change From Baseline in Inspiratory Capacity (IC) Within 2 Hours Post-dosing Over 24 Weeks
timeFrame: From Baseline (Day 1) up to 24 weeks
measure: Mean Transition Dyspnea Index (TDI) Focal Score Over 24 Weeks
timeFrame: From Baseline (Day -7 or 1) up to 24 weeks
measure: Mean Change From Baseline in Early Morning Symptoms of COPD Instrument (EMSCI) Over 24 Weeks
timeFrame: From Baseline (Day -7) up to 24 weeks
Other outcomes:
measure: Mean Change From Baseline in Night-Time Symptoms of COPD Instrument (NiSCI) Over 24 Weeks
timeFrame: From Baseline (Day -7) up to 24 weeks
measure: Mean Change From Baseline in Daily Rescue (Albuterol/Salbutamol MDI) Use Over 24 Weeks
timeFrame: From Baseline (Day -7) up to 24 weeks
measure: Mean Change From Baseline in COPD Assessment Test (CAT) Score Over 24 Weeks
timeFrame: From Baseline (Day -7 or 1) up to 24 weeks
Locations:
city: Tempe
country: United States
facility: Research Site
state: Arizona
city: Escondido
country: United States
facility: Research Site
state: California
city: Sacramento
country: United States
facility: Research Site
state: California
city: Hollywood
country: United States
facility: Research Site
state: Florida
city: Lawrenceville
country: United States
facility: Research Site
state: Georgia
city: Rincon
country: United States
facility: Research Site
state: Georgia
city: Farmington Hills
country: United States
facility: Research Site
state: Michigan
city: Bronx
country: United States
facility: Research Site
state: New York
city: Gastonia
country: United States
facility: Research Site
state: North Carolina
city: Dublin
country: United States
facility: Research Site
state: Ohio
city: Pittsburgh
country: United States
facility: Research Site
state: Pennsylvania
city: Greenville
country: United States
facility: Research Site
state: South Carolina
city: Spartanburg
country: United States
facility: Research Site
state: South Carolina
city: Sherman
country: United States
facility: Research Site
state: Texas
city: Tomball
country: United States
facility: Research Site
state: Texas
city: Dupnitsa
country: Bulgaria
facility: Research Site
city: Dupnitsa
country: Bulgaria
facility: Research Site
city: Haskovo
country: Bulgaria
facility: Research Site
city: Kozloduy
country: Bulgaria
facility: Research Site
city: Pazardzhik
country: Bulgaria
facility: Research Site
city: Petrich
country: Bulgaria
facility: Research Site
city: Pleven
country: Bulgaria
facility: Research Site
city: Plovdiv
country: Bulgaria
facility: Research Site
city: Razlog
country: Bulgaria
facility: Research Site
city: Ruse
country: Bulgaria
facility: Research Site
city: Sliven
country: Bulgaria
facility: Research Site
city: Smolyan
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Stara Zagora
country: Bulgaria
facility: Research Site
city: Varna
country: Bulgaria
facility: Research Site
city: Vidin
country: Bulgaria
facility: Research Site
city: Sherwood Park
country: Canada
facility: Research Site
state: Alberta
city: Winnipeg
country: Canada
facility: Research Site
state: Manitoba
city: Truro
country: Canada
facility: Research Site
state: Nova Scotia
city: Burlington
country: Canada
facility: Research Site
state: Ontario
city: Burlington
country: Canada
facility: Research Site
state: Ontario
city: Etobicoke
country: Canada
facility: Research Site
state: Ontario
city: Windsor
country: Canada
facility: Research Site
state: Ontario
city: Windsor
country: Canada
facility: Research Site
state: Ontario
city: Gatineau
country: Canada
facility: Research Site
state: Quebec
city: Levis
country: Canada
facility: Research Site
state: Quebec
city: St Charles Borromee
country: Canada
facility: Research Site
state: Quebec
city: Quebec
country: Canada
facility: Research Site
city: Quebec
country: Canada
facility: Research Site
city: Quebec
country: Canada
facility: Research Site
city: Besancon Cedex
country: France
facility: Research Site
city: Brest Cedex
country: France
facility: Research Site
city: Lyon Cedex 04
country: France
facility: Research Site
city: Montpellier
country: France
facility: Research Site
city: Nantes Cedex 2
country: France
facility: Research Site
city: Pessac
country: France
facility: Research Site
city: Poitiers
country: France
facility: Research Site
city: Reims
country: France
facility: Research Site
city: Balassagyarmat
country: Hungary
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Debrecen
country: Hungary
facility: Research Site
city: Debrecen
country: Hungary
facility: Research Site
city: Farkasgyepü
country: Hungary
facility: Research Site
city: Hajdúnánás
country: Hungary
facility: Research Site
city: Komló
country: Hungary
facility: Research Site
city: Komárom
country: Hungary
facility: Research Site
city: Miskolc
country: Hungary
facility: Research Site
city: Püspökladány
country: Hungary
facility: Research Site
city: Siófok
country: Hungary
facility: Research Site
city: Szeged
country: Hungary
facility: Research Site
city: Szombathely
country: Hungary
facility: Research Site
city: Vásárosnamény
country: Hungary
facility: Research Site
city: Barnaul
country: Russian Federation
facility: Research Site
city: Barnaul
country: Russian Federation
facility: Research Site
city: Chelyabinsk
country: Russian Federation
facility: Research Site
city: Ekaterinburg
country: Russian Federation
facility: Research Site
city: Izhevsk
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Novosibirsk
country: Russian Federation
facility: Research Site
city: Penza
country: Russian Federation
facility: Research Site
city: Penza
country: Russian Federation
facility: Research Site
city: Ryazan
country: Russian Federation
facility: Research Site
city: Saint Petersburg
country: Russian Federation
facility: Research Site
city: Saint Petersburg
country: Russian Federation
facility: Research Site
city: Saint Petersburg
country: Russian Federation
facility: Research Site
city: Saint-Petersburg
country: Russian Federation
facility: Research Site
city: Saint-Petersburg
country: Russian Federation
facility: Research Site
city: Saint-Petersburg
country: Russian Federation
facility: Research Site
city: Saratov
country: Russian Federation
facility: Research Site
city: Smolensk
country: Russian Federation
facility: Research Site
city: St. Petersburg
country: Russian Federation
facility: Research Site
city: Tomsk
country: Russian Federation
facility: Research Site
city: Ulyanovsk
country: Russian Federation
facility: Research Site
city: Chernivtsi
country: Ukraine
facility: Research Site
city: Chernivtsi
country: Ukraine
facility: Research Site
city: Ivano-Frankivsk
country: Ukraine
facility: Research Site
city: Kharkiv
country: Ukraine
facility: Research Site
city: Kharkiv
country: Ukraine
facility: Research Site
city: Kharkiv
country: Ukraine
facility: Research Site
city: Kyiv
country: Ukraine
facility: Research Site
city: Kyiv
country: Ukraine
facility: Research Site
city: Lutsk
country: Ukraine
facility: Research Site
city: Lviv
country: Ukraine
facility: Research Site
city: Odesa
country: Ukraine
facility: Research Site
city: Poltava
country: Ukraine
facility: Research Site
city: Vinnytsia
country: Ukraine
facility: Research Site
city: Vinnytsia
country: Ukraine
facility: Research Site
city: Zaporizhzhia
country: Ukraine
facility: Research Site
Study officials:
References:
citation: 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.