Status:
COMPLETED
Safety and Tolerability of Aclidinium Bromide/Formoterol Fumarate Compared With Formoterol Fumarate in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
Lead Sponsor:
AstraZeneca
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
40+ years
Phase:
PHASE3
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 19 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2013
Estimated Enrollment :
590 Patients enrolled
Trial Details
Trial ID
NCT01437540
Start Date
September 19 2011
End Date
April 30 2013
Last Update
May 11 2017
Active Locations (137)
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1
Forest Investigative Site 1162
Birmingham, Alabama, United States, 35209
2
Forest Investigative Site 1493
Birmingham, Alabama, United States, 35209
3
Forest Investigative Site 1620
Birmingham, Alabama, United States, 35235
4
Forest Investigative Site 1127
Mobile, Alabama, United States, 36608