Efficacy Safety Study of Arformoterol/Tiotropium Combination Versus Either Therapy Alone in Chronic Obstructive Pulmonary Disease (COPD)
A Two-Week, Randomized, Modified-Blind, Double-Dummy, Parallel-Group Efficacy and Safety Study of Arformoterol Tartrate Inhalation Solution Twice-Daily, Tiotropium Once-Daily, and Arformoterol Tartrate Inhalation Solution Twice-Daily and Tiotropium Once Daily in Subjects With Chronic Obstructive Pulmonary Disease
1 other identifier
interventional
235
1 country
28
Brief Summary
The purpose of this study is to evaluate and compare the efficacy of arformoterol twice a day and tiotropium once a day (dosed sequentially) versus tiotropium once a day alone in subjects with Chronic Obstructive Pulmonary Disease (COPD).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 chronic-obstructive-pulmonary-disease
Started Dec 2006
Shorter than P25 for phase_4 chronic-obstructive-pulmonary-disease
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2006
CompletedFirst Submitted
Initial submission to the registry
January 17, 2007
CompletedFirst Posted
Study publicly available on registry
January 19, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2007
CompletedResults Posted
Study results publicly available
April 2, 2009
CompletedJune 4, 2012
May 1, 2012
10 months
January 17, 2007
October 24, 2008
May 29, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time-normalized Area Under the Change From Study Baseline Curve for Forced Expiratory Volume in One Second (FEV1) Over 24 Hours (nAUC0-24B)
24 hours following two weeks of dosing.
Secondary Outcomes (15)
Time-normalized Area From Study Baseline Curve for FEV1 Over 0-12 Hours (nAUC0-12B)
0-12 hours following two weeks of dosing
Time Normalized Area Under the Change From Study Baseline Curve for FEV1 Over 12-24 Hours (nAUC12-24B)
Following 2 weeks of dosing
Change in FEV1 From Study Baseline to the 24-hour Timepoint (Trough)
Following 2 weeks of dosing
Change in FEV1 From Study Baseline at Each Assessed Timepoint Post First Dose of Study Medication
2 weeks
Change in FEV1 Percent of Predicted From Study Baseline at Each Assessed Timepoint Post First Dose of Study Medication
2 weeks
- +10 more secondary outcomes
Study Arms (3)
Arformoterol 15 mcg twice daily
ACTIVE COMPARATORArformoterol 15 mcg twice daily/Placebo Inhalation Powder
Tiotropium 18 mcg once daily
ACTIVE COMPARATORTiotropium 18 mcg once daily/Placebo Inhalation Solution
Arformoterol /Tiotropium
EXPERIMENTALArformoterol 15 mcg twice daily/Tiotropium 18 mcg once daily
Interventions
Arformoterol tartrate inhalation solution 15 mcg twice daily and placebo inhalation powder once daily.
Placebo inhalation solution twice daily and tiotropium inhalation powder 18 mcg once daily.
Arformoterol tartrate inhalation solution 15 mcg twice daily and Tiotropium inhalation powder 18 mcg once daily.
Placebo inhalation solution and placebo inhalation powder
Eligibility Criteria
You may qualify if:
- Male and female subjects must be at least 45 years old at the time of consent.
- Subjects must have a pre-established primary clinical diagnosis of COPD.
- Subjects must have a baseline FEV1 of ≤65% of predicted normal value at Visit 1.
- Subjects must have a FEV1 ≥ 0.70L at Visit 1.
You may not qualify if:
- Subjects who do not have a FEV1/forced vital capacity (FVC) ratio of ≤70% at Visit 1.
- Subjects who do not have a ³15 pack-year smoking history and a baseline breathlessness severity grade of ³2 (Modified Medical Research Council \[MMRC\] Dyspnea Scale Score) at Visit 1.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (28)
Unknown Facility
Jasper, Alabama, 35501, United States
Unknown Facility
Tucson, Arizona, 85715, United States
Unknown Facility
San Diego, California, 92120, United States
Unknown Facility
Colorado Springs, Colorado, 80909, United States
Unknown Facility
DeFuniak Springs, Florida, 32435, United States
Unknown Facility
DeLand, Florida, 32720, United States
Unknown Facility
Topeka, Kansas, 66606, United States
Unknown Facility
Hazard, Kentucky, 41701, United States
Unknown Facility
Madisonville, Kentucky, 42431, United States
Unknown Facility
Marrero, Louisiana, 70072, United States
Unknown Facility
Sunset, Louisiana, 70584, United States
Unknown Facility
Ann Arbor, Michigan, 48106, United States
Unknown Facility
Kalamazoo, Michigan, 49007, United States
Unknown Facility
Saint Charles, Missouri, 63301, United States
Unknown Facility
Charlotte, North Carolina, 28207, United States
Unknown Facility
Cincinnati, Ohio, 45242, United States
Unknown Facility
Columbus, Ohio, 43215, United States
Unknown Facility
Eugene, Oregon, 97404, United States
Unknown Facility
Medford, Oregon, 97504, United States
Unknown Facility
Portland, Oregon, 97213, United States
Unknown Facility
East Providence, Rhode Island, 02914, United States
Unknown Facility
Lincoln, Rhode Island, 02865, United States
Unknown Facility
Columbia, South Carolina, 29201, United States
Unknown Facility
Simpsonville, South Carolina, 29681, United States
Unknown Facility
Spartanburg, South Carolina, 29303, United States
Unknown Facility
Knoxville, Tennessee, 37920, United States
Unknown Facility
Tacoma, Washington, 98405, United States
Unknown Facility
Morgantown, West Virginia, 26505, United States
Related Publications (1)
Tashkin DP, Donohue JF, Mahler DA, Huang H, Goodwin E, Schaefer K, Hanrahan JP, Andrews WT. Effects of arformoterol twice daily, tiotropium once daily, and their combination in patients with COPD. Respir Med. 2009 Apr;103(4):516-24. doi: 10.1016/j.rmed.2008.12.014. Epub 2009 Feb 8.
PMID: 19208459DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
As of October 24, 2008, Sepracor is unaware of any limitations or caveats associated with this study.
Results Point of Contact
- Title
- Respiratory Medical Affairs Director
- Organization
- Sepracor Inc
Study Officials
- STUDY DIRECTOR
William Andrews, M.D.
Sumitomo Pharma America, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 17, 2007
First Posted
January 19, 2007
Study Start
December 1, 2006
Primary Completion
October 1, 2007
Study Completion
October 1, 2007
Last Updated
June 4, 2012
Results First Posted
April 2, 2009
Record last verified: 2012-05