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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03162055
• Date of registration: 19/05/2017
• Prospective Registration: Yes
• Primary sponsor: AstraZeneca
• Public title: 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
• Scientific 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)
• Date of first enrolment: May 25, 2017
• Target sample size: 1119
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03162055
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 3

Countries of recruitment

Bulgaria, Canada, France, Hungary, Russian Federation, Ukraine, United States

Key inclusion & exclusion 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.)



Age minimum: 40 Years
Age maximum: 95 Years
Gender: All

Health Condition(s) or Problem(s) studied

Chronic Obstructive Pulmonary Disease COPD

Intervention(s)

Drug: umeclidinium/vilanterol

Drug: Glycopyrronium/Formoterol Fumarate

Primary Outcome(s)

Mean Peak Change From Baseline in FEV1 Within 2 Hours Post-dosing Over 24 Weeks in FAS Population [Time Frame: From Baseline (Day 1) up to 24 weeks]

Mean Change From Baseline in Morning Pre-dose Trough Forced Expiratory Volume in 1 Second (FEV1) Over 24 Weeks [Time Frame: 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 [Time Frame: From Baseline (Day 1) up to 24 weeks]

Secondary Outcome(s)

Mean Change From Baseline in Early Morning Symptoms of COPD Instrument (EMSCI) Over 24 Weeks [Time Frame: From Baseline (Day -7) up to 24 weeks]

Mean Peak Change From Baseline in Inspiratory Capacity (IC) Within 2 Hours Post-dosing Over 24 Weeks [Time Frame: From Baseline (Day 1) up to 24 weeks]

Percentage of Participants With Increase of FEV1 of >=100 mL From Baseline at 5 Minutes Post-dosing on Day 1 [Time Frame: 5 minutes post-dose on Day 1]

Mean Transition Dyspnea Index (TDI) Focal Score Over 24 Weeks [Time Frame: From Baseline (Day -7 or 1) up to 24 weeks]

Secondary ID(s)

D5970C00002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

eResearchTechnology

QuintilesIMS Limited

Corporate Translations Inc

Parexel International Ltd

Center for Information & Study on Clinical Research Participation (CISCRP)

Cognizant Technology Solution

Results

• Results available: Yes
• Date Posted: 22/05/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03162055