Safety and Tolerability of Aclidinium Bromide/Formoterol Fumarate Compared With Formoterol Fumarate in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Drug: Aclidinium Bromide/Formoterol Fumarate; Drug: Formoterol Fumarate

Study type: Interventional

Funder types: Industry

Identifiers

NCT01437540

LAC-MD-32

Details and patient eligibility

About

The purpose of this study is to assess the long-term safety and tolerability of inhaled aclidinium bromide/formoterol in patients with moderate to severe, stable chronic obstructive pulmonary disease (COPD).

Enrollment: 590 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Current or former cigarette smokers with a cigarette smoking history of at least 10 pack-years
• A diagnosis of stable moderate to severe COPD and stable airway obstruction as defined by the Global Initiative for Chronic Obstructive Lung Disease guidelines and stable airway obstruction.

Exclusion criteria

• Patients who have been hospitalized for an acute COPD exacerbation within three months prior to Visit 1
• Any respiratory tract infection (including the upper respiratory tract) or COPD exacerbation in the six weeks before Visit 1.
• Patients with any clinically significant respiratory conditions other than COPD
• Clinical history that suggests that the patient has asthma as opposed to COPD
• Chronic use of oxygen therapy ≥ 15 hours/day
• Patients with clinically significant cardiovascular conditions
• Patients with uncontrolled infection that may place the patient at risk resulting from human immunodeficiency virus (HIV), active hepatitis and/or patients with diagnosed active tuberculosis
• Patients with a history of hypersensitivity reaction to inhaled anticholinergics,
• Patients with Stage II hypertension, defined as systolic pressure of 160 and above, and/or diastolic pressure of 100 and above
• Current diagnosis of cancer other than basal or squamous cell skin cancer

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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590 participants in 2 patient groups

1

Experimental group

Description:

Inhaled aclidinium bromide 400 μg/formoterol fumarate 12 μg fixed dose combination (FDC), high dose twice per day

Treatment:

Drug: Aclidinium Bromide/Formoterol Fumarate

2

Active Comparator group

Description:

Inhaled formoterol fumarate 12 μg, twice per day

Treatment:

Drug: Formoterol Fumarate