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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)

This study has been completed.
Sponsor:
Collaborator:
Almirall, S.A.
Information provided by (Responsible Party):
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT01437540
First received: September 19, 2011
Last updated: April 5, 2013
Last verified: April 2013

September 19, 2011
April 5, 2013
September 2011
March 2013   (final data collection date for primary outcome measure)
  • Adverse event (AE) recording [ Time Frame: From Baseline (Week 0) to Week 52 ] [ Designated as safety issue: Yes ]
    Number of patients to experience a Treatment Emergent Adverse Event (TEAE)
  • Vital Signs [ Time Frame: From Baseline (Week 0) to Week 52 ] [ Designated as safety issue: Yes ]
    Number of patients to experience a potentially clinically significant (PCS) change in pulse rate, systolic and diastolic blood pressure, body temperature or body weight.
  • Electrocardiograms (ECGs) [ Time Frame: From Baseline (Week 0) to Week 52 ] [ Designated as safety issue: Yes ]
    Number of patients to experience potentially clinically significant changes in ECG from Baseline.
  • Clinical Laboratory Measures [ Time Frame: From Baseline (Week 0) to Week 52 ] [ Designated as safety issue: Yes ]
    Number of patients to experience a potentially clinically significant (PCS) change in clinical laboratory values for Hematology, Chemistry, Urinalysis or Theophylline.
  • Adverse event (AE) recording [ Time Frame: From Baseline (Week 0) to Week 52 ] [ Designated as safety issue: Yes ]
    Number of patients to experience a Treatment Emergant Adverse Event (TEAE)
  • Vital Signs [ Time Frame: From Baseline (Week 0) to Week 52 ] [ Designated as safety issue: Yes ]
    Number of patients to experience a potentially clinically significant (PCS) change in pulse rate, systolic and diastolic blood pressure, body temperature or body weight.
  • Electrocardiograms (ECGs) [ Time Frame: From Baseline (Week 0) to Week 52 ] [ Designated as safety issue: Yes ]
    Number of patients to experience potentially clinically significant changes in ECG from Baseline.
  • Clinical Laboratory Measures [ Time Frame: From Baseline (Week 0) to Week 52 ] [ Designated as safety issue: Yes ]
    Number of patients to experience a potentially clinically significant (PCS) change in clinical laboratory values for Hematology, Chemistry, Urinalysis or Theophylline.
Complete list of historical versions of study NCT01437540 on ClinicalTrials.gov Archive Site
Not Provided
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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
A Long-Term, Randomized, Study of the Safety and Tolerability of a Fixed-Dose Combination of Aclidinium Bromide/Formoterol Fumarate Compared With Formoterol Fumarate in Patients With Moderate to Severe, Stable Chronic Obstructive Pulmonary Disease (COPD)

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).

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Chronic Obstructive Pulmonary Disease
  • Drug: Aclidinium Bromide/Formoterol Fumarate
    Inhaled Aclidinium/formoterol high dose twice per day
  • Drug: Formoterol Fumarate
    Inhaled Formoterol 12 μg, twice per day
  • Experimental: 1
    Aclidinium/formoterol FDC, high dose twice per day
    Intervention: Drug: Aclidinium Bromide/Formoterol Fumarate
  • Active Comparator: 2
    Formoterol 12 μg
    Intervention: Drug: Formoterol Fumarate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
590
April 2013
March 2013   (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 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
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01437540
LAC-MD-32
Yes
Forest Laboratories
Forest Laboratories
Almirall, S.A.
Study Director: Thomas Goodin, PhD Forest Laboratories
Forest Laboratories
April 2013

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