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

This study has been completed.
Sponsor:
Collaborator:
Almirall, S.A.
Information provided by (Responsible Party):
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT01437397
First received: September 19, 2011
Last updated: April 5, 2013
Last verified: April 2013

September 19, 2011
April 5, 2013
September 2011
February 2013   (final data collection date for primary outcome measure)
  • Morning pre-dose (trough) Forced Expiratory Volume in one second (FEV1) at Week 24 [ Time Frame: Change from Basline (Week 0) to 24 Weeks ] [ Designated as safety issue: No ]
  • Morning one-hour post-dose FEV1 at Week 24 [ Time Frame: Change from Basline (Week 0) to 24 Weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01437397 on ClinicalTrials.gov Archive Site
  • Change from baseline in George's Respiratory Questionnaire (SGRQ) total score [ Time Frame: Change from Basline (Week 0) to 24 Weeks ] [ Designated as safety issue: No ]
  • Improvement in Transition Dyspnea Index (TDI) score [ Time Frame: Change from Basline (Week 0) to 24 Weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Efficacy, Safety and Tolerability of Aclidinium Bromide/Formoterol Fumarate Compared With Formoterol Fumarate in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
A Phase III, Randomized, Double-blind, Placebo-Controlled Study Evaluating the Efficacy, Safety, and Tolerability of Two Fixed Dose Combinations of Aclidinium Bromide/Formoterol Fumarate Compared With Aclidinium Bromide, Formoterol Fumarate and Placebo for 24- Weeks Treatment in Patients With Moderate to Severe, Stable Chronic Obstructive Pulmonary Disease (COPD)

The purpose of this Phase III study is to assess the maintenance bronchodilator effects of the fixed dose combination versus monotherapies. This study will also assess the effects of the fixed dose combination in terms of COPD symptoms, disease related health status and the long-term safety and tolerability of the fixed dose combination. This study will include a 24 week treatment period, preceding by a run-in period, followed by a two week follow up visit. All patients will be randomized to one of four treatment arms or placebo.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy 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 FDC high dose, twice per day
  • Drug: Aclidinium Bromide/Formoterol Fumarate
    Inhaled Aclidinium/formoterol FDC low dose, twice per day
  • Drug: Aclidinium Bromide
    Inhaled Aclidinium 400 μg, twice per day
  • Drug: Formoterol Fumarate
    Inhaled Formoterol 12 μg, twice per day
  • Drug: placebo
    Inhaled dose-matched placebo, twice per day
  • Experimental: 1
    Aclidinium/formoterol Fixed Dose Combination (FDC) high dose
    Intervention: Drug: Aclidinium Bromide/Formoterol Fumarate
  • Experimental: 2
    Aclidinium/formoterol Fixed Dose Combination (FDC) low dose
    Intervention: Drug: Aclidinium Bromide/Formoterol Fumarate
  • Active Comparator: 3
    Aclidinium monotherapy 400 μg
    Intervention: Drug: Aclidinium Bromide
  • Active Comparator: 4
    Formoterol monotherapy 12 μg
    Intervention: Drug: Formoterol Fumarate
  • Placebo Comparator: 5
    Placebo
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1692
March 2013
February 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 a history of hypersensitivity reaction to inhaled anticholinergics
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Canada,   New Zealand
 
NCT01437397
LAC-MD-31
No
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