Comparison of Aclidinium Bromide and Formoterol Fumarate in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

May 8, 2017 updated by: AstraZeneca

A Randomized, Double-Blind, Active-Controlled, Parallel-Group, Multicenter, 4-Week Pilot Study to Assess Symptoms in Stable, Moderate to Severe COPD Patients Taking Aclidinium Bromide 200 mcg Once Daily in Combination With Formoterol Fumarate Once or Twice Daily Versus Formoterol Fumarate Twice Daily

This exploratory study will compare the efficacy of the fixed-dose combination (FDC) of aclidinium bromide and formoterol fumarate once daily in the morning and placebo once in the evening vs. the FDC once daily in the morning and formoterol fumarate once in the evening vs. formoterol fumarate twice daily. The study will assess pulmonary function and symptoms in patients with moderate to severe COPD.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

156

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85741
        • Forest Investigative Site
      • Tucson, Arizona, United States, 85715
        • Forest Investigative Site
    • California
      • Fullerton, California, United States, 92835
        • Forest Investigative Site
      • Lakewood, California, United States, 90712
        • Forest Investigative Site
      • Rancho Mirage, California, United States, 92270
        • Forest Investigative Site
      • Redlands, California, United States, 92373
        • Forest Investigative Site
      • San Diego, California, United States, 92120
        • Forest Investigative Site
      • San Jose, California, United States, 95124
        • Forest Investigative Site
      • Stockton, California, United States, 95207
        • Forest Investigative Site
    • Colorado
      • Wheat Ridge, Colorado, United States, 80033
        • Forest Investigative Site
    • Connecticut
      • Hartford, Connecticut, United States, 06105
        • Forest Investigative Site
      • New Britain, Connecticut, United States, 06053
        • Forest Investigative Site
      • Waterbury, Connecticut, United States, 06708
        • Forest Investigative Site
    • Florida
      • DeLand, Florida, United States, 32720
        • Forest Investigative Site
      • Panama City, Florida, United States, 32405
        • Forest Investigative Site
      • Tamarac, Florida, United States, 33321
        • Forest Investigative Site
      • Tampa, Florida, United States, 33603
        • Forest Investigative Site
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Forest Investigative Site
      • Austell, Georgia, United States, 30106
        • Forest Investigative Site
      • Blue Ridge, Georgia, United States, 30513
        • Forest Investigative Site
    • Kentucky
      • Bowling Green, Kentucky, United States, 42101
        • Forest Investigative Site
      • Hazard, Kentucky, United States, 41701
        • Forest Investigative Site
    • Massachusetts
      • North Dartmouth, Massachusetts, United States, 02747
        • Forest Investigative Site
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Forest Investigative Site
    • Missouri
      • Florissant, Missouri, United States, 63033
        • Forest Investigative Site
      • Saint Charles, Missouri, United States, 63301
        • Forest Investigative Site
      • Saint Louis, Missouri, United States, 63110
        • Forest Investigative Site
    • New York
      • Albany, New York, United States, 12205
        • Forest Investigative Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • Forest Investigative Site
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • Forest Investigative Site
      • Columbus, Ohio, United States, 43215
        • Forest Investigative Site
    • Oregon
      • Medford, Oregon, United States, 97504
        • Forest Investigative Site
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Forest Investigative Site
    • Rhode Island
      • East Providence, Rhode Island, United States, 02914
        • Forest Investigative Site
    • South Carolina
      • Spartanburg, South Carolina, United States, 29303
        • Forest Investigative Site
    • Texas
      • Dallas, Texas, United States, 75246
        • Forest Investigative Site
      • McKinney, Texas, United States, 75069
        • Forest Investigative Site
    • Utah
      • Midvale, Utah, United States, 84047
        • Forest Investigative Site
    • Virginia
      • Richmond, Virginia, United States, 23225
        • Forest Investigative Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53209
        • Forest Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Moderate to severe COPD
  • Smoking history of greater or equal to 10 pack-years
  • Diagnosis of stable moderate to severe COPD as defined by the GOLD Guidelines
  • Postbronchodilator FEV1 from 30% to 79% of predicted values, inclusive
  • Postbronchodilator FEV1/FVC ratio < 0.70

Exclusion Criteria:

  • History or presence of asthma, allergic rhinitis, or exercise-induced bronchospasm
  • Hospitalization for an acute COPD exacerbation in the 3 months prior to study entry
  • Respiratory tract infection (including the upper respiratory tract) or COPD exacerbation in the 6 weeks prior to study entry
  • Eosinophil count of at least 600 cells/mm3
  • Long term oxygen therapy > 15 hours a day

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Once-daily aclidinium/formoterol
Aclidinium bromide 200 µg/ formoterol fumarate 12 µg fixed-dose combination (FDC) once-daily in the morning, plus placebo once-daily in the evening
Drug: Once-daily aclidinium/formoterol
Inhaled aclidinium bromide 200 µg/formoterol fumarate 12 µg fixed-dose combination once-daily in the morning
Drug: Placebo to formoterol fumarate
Inhaled placebo to formoterol fumarate once-daily in the evening
EXPERIMENTAL: Morning aclidinium/formoterol plus evening formoterol
Aclidinium bromide 200 µg/formoterol fumarate 12 µg FDC once-daily in the morning, plus formoterol fumarate 12µg once-daily in the evening
Drug: Once-daily aclidinium/formoterol
Inhaled aclidinium bromide 200 µg/formoterol fumarate 12 µg fixed-dose combination once-daily in the morning
Drug: Once-daily formoterol fumarate
Inhaled formoterol fumarate 12 μg once-daily in the evening
ACTIVE_COMPARATOR: Formoterol BID
Formoterol fumarate 12 µg twice-daily (BID)
Drug: Twice-daily formoterol fumarate
Inhaled formoterol fumarate 12 µg twice-daily (BID)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Weekly Average Nocturnal Symptom Scores
Time Frame: Week 4 of treatment
Nocturnal Symptom Score Scale: 0 = None; 1 = Symptoms causing early awakening or awakening once during the night; 2 = Symptoms causing early awakening or awakening two or more times during the night; 3 = Symptoms causing awakening for most time during the night, 4 = Symptoms which were so severe that I could not sleep at all
Week 4 of treatment
Change From Baseline in Weekly Average Daily (24 Hour) Sputum Volume Scores
Time Frame: Week 4 of treatment
Sputum Volume Score Scale: 0 = None; 1 = The amount of one teaspoon; 2 = The amount of one tablespoon; 3 = More than one tablespoon
Week 4 of treatment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1)
Time Frame: Week 4 of treatment
The trough value for each pulmonary function parameter was defined as the mean of the two greatest readings assessed 23 hours and 24 hours following the administration of the morning dose of the previous day
Week 4 of treatment
Change From Baseline in Peak Forced Expiratory Volume in One Second (FEV1)
Time Frame: Week 4 of treatment
Week 4 of treatment
Change From Baseline in Normalized Area Under the Curve (0-3 hr) of Forced Expiratory Volume in One Second (FEV1)
Time Frame: Week 4 of treatment
FEV1 values obtained at 30, 60, 120, and 180 minutes after the morning study drug dose
Week 4 of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 30, 2008

Primary Completion (ACTUAL)

November 11, 2008

Study Completion (ACTUAL)

November 11, 2008

Study Registration Dates

First Submitted

June 26, 2008

First Submitted That Met QC Criteria

June 27, 2008

First Posted (ESTIMATE)

June 30, 2008

Study Record Updates

Last Update Posted (ACTUAL)

May 15, 2017

Last Update Submitted That Met QC Criteria

May 8, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LAC-MD-24

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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