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)

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Chronic Obstructive Pulmonary Disease COPD

Treatments: Drug: Glycopyrronium/Formoterol Fumarate; Drug: umeclidinium/vilanterol

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT03162055

D5970C00002

Details and patient eligibility

About

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.

Enrollment: 1,119 patients

Sex: All

Ages: 40 to 95 years old

Volunteers: No Healthy Volunteers

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.)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,119 participants in 2 patient groups

Experimental

Experimental group

Description:

glycopyrronium/formoterol fumarate 7.2/4.8 μg per actuation, twice daily

Treatment:

Drug: Glycopyrronium/Formoterol Fumarate

Active comparator

Active Comparator group

Description:

umeclidinium/vilanterol 62.5/ 25μg per inhalation, once daily

Treatment:

Drug: umeclidinium/vilanterol