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

• Status: Completed
• Trial end date: 2013-04-30
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Bromides; Formoterol Fumarate

Criteria

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