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

Completed · Phase 3

Conditions studied: Chronic Obstructive Pulmonary Disease

In brief

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).

Key facts

Study ID

NCT01437540

Run by

AstraZeneca

People needed

590

Starts

2011-09-19

Expected to finish

2013-04-30

Last updated by the study team

2017-05-11

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Forest Investigative Site 1493 — Birmingham, Alabama, United States
• Forest Investigative Site 1620 — Birmingham, Alabama, United States
• Forest Investigative Site 1127 — Mobile, Alabama, United States
• Forest Investigative Site 1613 — Chandler, Arizona, United States
• Forest Investigative Site 1623 — Peoria, Arizona, United States
• Forest Investigative Site 1582 — Phoenix, Arizona, United States
• Forest Investigative Site 1379 — Phoenix, Arizona, United States
• Forest Investigative Site 1581 — Phoenix, Arizona, United States
• Forest Investigative Site 1571 — Phoenix, Arizona, United States
• Forest Investigative Site 1596 — Fort Smith, Arkansas, United States
• Forest Investigative Site 1547 — Encinitas, California, United States
• Forest Investigative Site 1088 — Lakewood, California, United States
• Forest Investigative Site 1624 — Los Angeles, California, United States
• Forest Investigative Site 1927 — Los Angeles, California, United States
• Forest Investigative Site 1388 — Paramount, California, United States
• Forest Investigative Site 1503 — San Diego, California, United States
• Forest Investigative Site 1374 — Torrance, California, United States
• Forest Investigative Site 1331 — Vista, California, United States
• Forest Investigative Site 2039 — Walnut Creek, California, United States
• Forest Investigative Site 1597 — Boulder, Colorado, United States
• Forest Investigative Site 1137 — Colorado Springs, Colorado, United States
• Forest Investigative Site 0892 — Denver, Colorado, United States
• Forest Investigative Site 2037 — Fort Collins, Colorado, United States
• Forest Investigative Site 1327 — Wheat Ridge, Colorado, United States
• Forest Investigative Site 1162 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.