Pharmacokinetic, Safety and Tolerability Study of Aclidinium/Formoterol Fixed Dose Combination and Formoterol in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
NCT ID: NCT01551888
Last Updated: 2017-02-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
24 participants
INTERVENTIONAL
2012-01-31
2012-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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Aclidinium/formoterol 400/12μg FDC
Aclidinium/formoterol 400/12μg fixed-dose combination (FDC), one inhalation twice daily (morning and evening) for 4 days, then one inhalation (morning) on Day 5 via the Almirall inhaler
Aclidinium/formoterol 400/12μg
Aclidinium/formoterol 400/12μg fixed dose combination (FDC), one inhalation twice daily (morning and evening) for 4 days, then one inhalation (morning) on Day 5 via the Almirall inhaler
Formoterol
Formoterol 12μg one inhalation twice daily (morning and evening) for 4 days, then one inhalation (morning) on Day 5 via the Foradil® Aerolizer®
Formoterol
Formoterol 12 μg one inhalation twice daily (morning and evening) for 4 days, then one inhalation (morning) on Day 5 via the Foradil® Aerolizer®
Interventions
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Aclidinium/formoterol 400/12μg
Aclidinium/formoterol 400/12μg fixed dose combination (FDC), one inhalation twice daily (morning and evening) for 4 days, then one inhalation (morning) on Day 5 via the Almirall inhaler
Formoterol
Formoterol 12 μg one inhalation twice daily (morning and evening) for 4 days, then one inhalation (morning) on Day 5 via the Foradil® Aerolizer®
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Any respiratory tract infection (including the upper respiratory tract) or COPD exacerbation in the six weeks before Screening
* 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 a history of hypersensitivity reaction to inhaled anticholinergics, beta-2 agonists, sympathomimetic amines, or inhaled medications
40 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Esther Garcia, MD
Role: STUDY_DIRECTOR
AstraZeneca
Locations
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Forest Investigative Site 001
Spartanburg, South Carolina, United States
Countries
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Related Links
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Other Identifiers
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LAC-PK-01
Identifier Type: -
Identifier Source: org_study_id
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