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

Sponsored by Forest Laboratories


Purpose

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).

 
ArmsAssigned Interventions
1: Experimental
Aclidinium/formoterol FDC, high dose
twice per day
Intervention: Drug: Aclidinium
Bromide/Formoterol Fumarate
Drug: Aclidinium Bromide/Formoterol
Fumarate
Inhaled Aclidinium/formoterol high
dose twice per day
2: Active Comparator
Formoterol 12 μg
Intervention: Drug: Formoterol Fumarate
Drug: Formoterol Fumarate
Inhaled Formoterol 12 μg, twice per
day

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Eligibility

Ages Eligible for Study:40 Years and older
Genders Eligible for StudyBoth
Accepts Healthy Volunteers:No

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

Contacts and Locations

Physicians:
James Tita, DO
Vijay Mahajan, MD
Srinivas Katragadda, MD

Coordinators:
Lisa Graham, RN, CCRC
Kristen Miller, BSN, CCRC

Please contact us at 419-251-4919 for more information about this study.
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