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

• Register: ClinicalTrials.gov
• Last refreshed on: 7 January 2013
• Main ID: NCT01437397
• Date of registration: 19/09/2011
• Primary sponsor: Forest Laboratories
• Public title: 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
• Scientific title: 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)
• Date of first enrolment: September 2011
• Target sample size: 1550
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT01437397
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Countries of recruitment

Australia, Canada, New Zealand, United States

Contacts

• Name: Thomas Goodin, PhD
• Affiliation: Forest Laboratories

Key inclusion & exclusion 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 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



Age minimum: 40 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Chronic Obstructive Pulmonary Disease

Intervention(s)

Drug: Aclidinium Bromide

Drug: Aclidinium Bromide/Formoterol Fumarate

Drug: Formoterol Fumarate

Drug: placebo

Primary Outcome(s)

Morning one-hour post-dose FEV1 at Week 24 [Time Frame: Change from Basline (Week 0) to 24 Weeks]

Morning pre-dose (trough) Forced Expiratory Volume in one second (FEV1) at Week 24 [Time Frame: Change from Basline (Week 0) to 24 Weeks]

Secondary Outcome(s)

Change from baseline in George's Respiratory Questionnaire (SGRQ) total score [Time Frame: Change from Basline (Week 0) to 24 Weeks]

Improvement in Transition Dyspnea Index (TDI) score [Time Frame: Change from Basline (Week 0) to 24 Weeks]

Secondary ID(s)

LAC-MD-31

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Almirall, S.A.