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Pharmacokinetic, Safety and Tolerability Study of Aclidinium/Formoterol Fixed Dose Combination and Formoterol in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

This study has been completed.
Sponsor:
Collaborator:
Almirall, S.A.
Information provided by (Responsible Party):
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT01551888
First received: March 9, 2012
Last updated: August 22, 2012
Last verified: August 2012
History of Changes
  Purpose

The purpose of this Phase II study is to evaluate the pharmacokinetics, safety, and tolerability of aclidinium/formoterol fixed dose combination (FDC 400/12 μg via the Almirall Inhaler and formoterol 12 μg via the Foradil® Aerolizer®, both administered twice daily for five days to patients with moderate to severe COPD.


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease (COPD)
 Drug: Aclidinium/Formoterol
Drug: Formoterol
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2a, Randomized, Open-Label, 2-Way Crossover Study To Determine The Pharmacokinetics, Safety, And Tolerability Of Aclidinium/Formoterol 400/12 µg Fixed Dose Combination Via Almirall Inhaler And Formoterol 12 µg Via Foradil® Aerolizer® In Patients With Moderate To Severe Chronic Obstructive Pulmonary Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Forest Laboratories:

Primary Outcome Measures:
  • Area under the formoterol plasma concentration-time curve over the dosing interval at steady state (AUCt,ss) [ Time Frame: Day 5 ] [ Designated as safety issue: No ]
  • Maximum formoterol plasma concentration at steady state (Cmax,ss) [ Time Frame: Day 5 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Area under the formoterol plasma concentration-time curve over the dosing interval following a single dose (AUCt) [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Maximum plasma concentration of formoterol following a single dose (Cmax) [ Time Frame: Day 1 ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: January 2012
Study Completion Date: April 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment A
Aclidinium/Formoterol 400 μg/12μg fixed-dose combination, one inhalation twice daily (morning and evening) for 4 days, then one inhalation (morning) on Day 5 via the Almirall inhaler
 Drug: Aclidinium/Formoterol
Aclidinium/Formoterol 400 μg/12μg fixed-dose combination, one inhalation twice daily (morning and evening) for 4 days, then one inhalation (morning) on Day 5 via the Almirall inhaler
Active Comparator: Treatment B
Formoterol 12 μg, one inhalation twice daily (morning and evening) for 4 days, then one inhalation (morning) on Day 5 via the Foradil® Aerolizer®
 Drug: 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®

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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 Screening
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01551888

Locations
United States, South Carolina
Forest Investigative Site 001
Spartanburg, South Carolina, United States, 29303
Sponsors and Collaborators
Forest Laboratories
Almirall, S.A.
Investigators
Study Director: Stephan Ortiz, PhD Forest Laboratories
  More Information

No publications provided

Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT01551888     History of Changes
Other Study ID Numbers: LAC-PK-01
Study First Received: March 9, 2012
Last Updated: August 22, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Forest Laboratories:
COPD
Chronic Obstructive Pulmonary Disease
Chronic Bronchitis
Emphysema
 Airflow Obstruction, Chronic
Chronic Airflow Obstruction
Chronic Obstructive Airway Disease
Chronic Obstructive Lung Disease

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Formoterol
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
 Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2013