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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

March 9, 2012
August 22, 2012
January 2012
March 2012   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01551888 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Pharmacokinetic, Safety and Tolerability Study of Aclidinium/Formoterol Fixed Dose Combination and Formoterol in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Chronic Obstructive Pulmonary Disease (COPD)
  • 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
  • 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®
  • 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
    Intervention: Drug: Aclidinium/Formoterol
  • 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®
    Intervention: Drug: Formoterol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
April 2012
March 2012   (final data collection date for primary outcome measure)

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
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01551888
LAC-PK-01
No
Forest Laboratories
Forest Laboratories
Almirall, S.A.
Study Director: Stephan Ortiz, PhD Forest Laboratories
Forest Laboratories
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP