Efficacy and Safety Study of Two Fixed-dose Combinations of Aclidinium Bromide With Formoterol Fumarate Compared With Aclidinium Bromide, Formoterol Fumarate and Placebo

NCT01049360 | Completed Phase 2 Results

• 1 other identifier: LAC-MD-27
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 20

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Chronic Obstructive Pulmonary Disease; COPD; Chronic Bronchitis; Emphysema; Airflow Obstruction, Chronic; Chronic Airflow Obstruction; Chronic Obstructive Airway Disease; Chronic Obstructive Lung Disease

Outcome Measures

Primary Outcomes (1)

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

  0 to 12 hours post-dose on Day 14

Secondary Outcomes (2)

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

  Day 14

• Change From Baseline in Morning Peak Forced Expiratory Volume in One Second (FEV1)

  Day 14

Study Arms (5)

Aclidinium 400 μg / Formoterol 12 μg

EXPERIMENTAL

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

Drug: Aclidinium 400 μg / Formoterol 12 μg

Aclidinium 400 μg / formoterol 6 μg

EXPERIMENTAL

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

Drug: Aclidinium 400 μg / Formoterol 6 μg

Aclidinium 400 μg

EXPERIMENTAL

Aclidinium bromide 400 μg administered twice-daily (BID)

Drug: Aclidinium 400 μg

Formoterol 12 μg

ACTIVE COMPARATOR

Formoterol fumarate 12 μg twice-daily

Drug: Formoterol 12 μg

Placebo

PLACEBO COMPARATOR

Placebo twice-daily

Drug: Placebo

Interventions

Aclidinium 400 μg / Formoterol 12 μg DRUG

Aclidinium bromide 400 μg / formoterol fumarate 12 μg fixed dose combination administered twice-daily (BID) for a 14 day period within four different treatment periods.

Aclidinium 400 μg / Formoterol 12 μg

Aclidinium 400 μg / Formoterol 6 μg DRUG

Aclidinium bromide 400 μg / formoterol fumarate 6 μg fixed dose combination administered twice-daily (BID) for a 14 day period within four different treatment periods.

Aclidinium 400 μg / formoterol 6 μg

Aclidinium 400 μg DRUG

Aclidinium bromide 400 μg administered twice-daily (BID) for a 14 day period within four different treatment periods.

Aclidinium 400 μg

Formoterol 12 μg DRUG

Formoterol fumarate 12 μg twice-daily for a 14 day period within four different treatment periods.

Formoterol 12 μg

Placebo DRUG

Placebo twice-daily delivered by inhalation for a 14 day period within four different treatment periods.

Placebo

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Have clinically significant cardiovascular conditions
• Have uncontrolled infection resulting from human immunodeficiency virus and/or active hepatitis
• Have symptomatic prostatic hypertrophy and/or bladder neck obstruction.
• Have narrow-angle glaucoma
• Have a history of hypersensitivity reaction (including report of paradoxical bronchospasm) to inhaled anticholinergics (including aclidinium bromide), β2 adrenergic agonists, or any other inhaled medication or any component thereof

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (20)

Forest Investigative Site 0909

Glendale, Arizona, 85306, United States

Location

Forest Investigative Site 2050

Pheonix, Arizona, 85006, United States

Location

Forest Investigative Site 2029

Rancho Mirage, California, 92270, United States

Location

Forest Investigative Site 1084

Stockton, California, 95207, United States

Location

Forest Investigative Site 2045

Wheat Ridge, Colorado, 80033, United States

Location

Forest Investigative Site 1152

Clearwater, Florida, 33765, United States

Location

Forest Investigative Site 2053

Tampa, Florida, 33603, United States

Location

Forest Investigative Site 2047

Tampa, Florida, 33613, United States

Location

Forest Investigative Site 1431

North Dartmouth, Massachusetts, 02747, United States

Location

Forest Investigative Site 2084

Summit, New Jersey, 07901, United States

Location

Forest Investigative Site 1119

Elmira, New York, 14901, United States

Location

Forest Investigative Site 2035

Elizabeth City, North Carolina, 27909, United States

Location

Forest Investigative Site 1153

Raleigh, North Carolina, 27607, United States

Location

Forest Investigative Site 2028

Cincinnati, Ohio, 45242, United States

Location

Forest Investigative Site 2043

Medford, Oregon, 97504, United States

Location

Forest Investigative Site 1106

Portland, Oregon, 97213, United States

Location

Forest Investigative Site 1089

East Providence, Rhode Island, 02914, United States

Location

Forest Investigative Site 1121

Spartanburg, South Carolina, 29303, United States

Location

Forest Investigative Site 1498

San Antonio, Texas, 78215, United States

Location

Forest Investigative Site 1129

Waco, Texas, 76712, United States

Location

Related Links

• lac-md-27-synopsis

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Bronchitis, Chronic; Emphysema

Interventions

aclidinium bromide; Formoterol Fumarate

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines

Results Point of Contact

• Title: Esther Garcia
• Organization: AstraZeneca

ClinicalTrialTransparency@astrazeneca.com

Study Officials

• Esther Garcia, MD

  AstraZeneca

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2010
• First Posted: January 14, 2010
• Study Start: December 1, 2009
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: February 28, 2017
• Results First Posted: November 9, 2016

Record last verified: 2017-01

Locations

US (20)