NCT01049360

Completed

Phase 2

Efficacy and Safety Study of Two Fixed-Dose Combinations of Aclidinium Bromide With Formoterol Fumarate Compared With Aclidinium Bromide, Formoterol Fumarate, and Placebo All Administered Twice Daily (BID) to Patients With Stable, Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

AstraZeneca20 sites in 1 country128 target enrollmentDecember 2009

ConditionsChronic Obstructive Pulmonary Disease

InterventionsAclidinium 400 μg / Formoterol 12 μg Aclidinium 400 μg / Formoterol 6 μg Aclidinium 400 μg Formoterol 12 μg Placebo

DrugsAclidinium 400 μg / Formoterol 12 μg Aclidinium 400 μg / Formoterol 6 μg Aclidinium 400 μg Formoterol 12 μg Placebo

Overview

Phase: Phase 2
Intervention: Aclidinium 400 μg / Formoterol 12 μg
Conditions: Chronic Obstructive Pulmonary Disease
Sponsor: AstraZeneca
Enrollment: 128
Locations: 20
Primary Endpoint: Change From Baseline in Normalized Forced Expiratory Volume in One Second (FEV1) Area Under the Curve Over 12 Hours (AUC0-12)
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the efficacy of this multicenter, randomized, double-blind, placebo-controlled, 4-period, incomplete-block crossover, dose-ranging study comparing 2 fixed dose combinations (FDCs) of aclidinium bromide with formoterol fumarate or with placebo, aclidinium bromide and formoterol fumarate, all administered twice a day (BID) in patients with stable, moderate to severe chronic obstructive pulmonary disease (COPD) beginning with a 2-week run-in period and with a 7-10 day washout each between treatment period.

Registry

clinicaltrials.gov

Start Date

December 2009

End Date

August 2010

Last Updated

9 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

AstraZeneca

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Understand the study procedures and be willing to participate in the study as indicated by signing the ICF and HIPAA form
•Be male or female aged 40 to 80 years, inclusive
•Have a diagnosis of stable, moderate to severe COPD (stages II and III) as defined by guidelines of the Global Initiative for Chronic Obstructive Lung Disease (2008)
•Be a current or former cigarette smoker with a smoking history of at least 10 pack-years
•Have post-albuterol/salbutamol FEV1 values ≥ 30% and \< 80% of the predicted value. FEV1 will be measured at the Screening Visit (Visit 1) between 10 and 15 minutes after inhalation of albuterol/salbutamol.
•Have post-albuterol/salbutamol FEV1/FVC values \< 70% (ie, 100 × post- albuterol/salbutamol FEV1/FVC \< 70%).
•If female, be at least 1 year postmenopausal or surgically sterile (defined as having a hysterectomy or tubal ligation). Women of childbearing potential must have a negative serum β-human chorionic gonadotropin pregnancy test at screening
•Be in good stable health (as judged by the Investigator) other than the COPD, based on medical history, physical examination, ECG, spirometry, and clinical laboratory data evaluations
•Have COPD symptoms and FEV1 values at the time of randomization that are stable compared with those at Screening (Visit 1), according to the Investigator's medical judgment

Exclusion Criteria

•Have been hospitalized for an acute COPD exacerbation within 3 months before screening
•Have any respiratory tract infection (including the upper respiratory tract) or signs of a COPD exacerbation or respiratory infection in the 6 weeks before Screening (Visit 1).
•Have any clinically significant respiratory conditions other than COPD
•Have a history or presence of asthma verified from medical records
•Have used theophylline (including long-acting theophylline) within the previous 3 months before study entry
•Have Stage II hypertension, defined as systolic pressure of 160 and above, and diastolic pressure of 100 and above
•Chronic use of oxygen therapy ≥ 15 hours a day
•Have a history, current diagnosis, or presence of exercise-induced bronchospasm
•Have a body mass index ≥ 40 kg/m2
•Have participated in an pulmonary rehabilitation program within the previous 3 months

Arms & Interventions

Aclidinium 400 μg / Formoterol 12 μg

Aclidinium bromide 400 μg / formoterol fumarate 12 μg fixed dose combination administered twice-daily (BID)

Intervention: Aclidinium 400 μg / Formoterol 12 μg

Aclidinium 400 μg / formoterol 6 μg

Aclidinium bromide 400 μg / formoterol fumarate 6 μg fixed dose combination administered twice-daily (BID)

Intervention: Aclidinium 400 μg / Formoterol 6 μg

Aclidinium 400 μg

Aclidinium bromide 400 μg administered twice-daily (BID)

Intervention: Aclidinium 400 μg

Formoterol 12 μg

Formoterol fumarate 12 μg twice-daily

Intervention: Formoterol 12 μg

Placebo

Placebo twice-daily

Intervention: Placebo

Outcomes

Primary Outcomes

Change From Baseline in Normalized Forced Expiratory Volume in One Second (FEV1) Area Under the Curve Over 12 Hours (AUC0-12)

Time Frame: 0 to 12 hours post-dose on Day 14

Secondary Outcomes

Change From Baseline in Morning Peak Forced Expiratory Volume in One Second (FEV1)(Day 14)
Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in One Second (FEV1)(Day 14)