Clinical trial NCT00424528: Efficacy Safety Study of Arformoterol/Tiotropium Combination Versus Either Therapy Alone in Chronic Obstructive Pulmonary Disease (COPD)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Obstructive Pulmonary Disease
Bronchitis
Emphysema
Keywords: COPD including chronic bronchitis and emphysema
Lead sponsor: Sumitomo Pharma America, Inc.
Sponsor class: INDUSTRY
First posted: 2007-01-19
Enrollment: 235
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Detailed description: This study is a multicenter, randomized, modified-blind, double-dummy two-week parallel-group efficacy and safety study of arformoterol tartrate inhalation solution twice daily, tiotropium inhalation powder once daily and arformoterol tartrate inhalation solution twice daily and tiotropium inhalation powder once daily (dosed sequentially) in subjects with COPD. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Time-normalized Area Under the Change From Study Baseline Curve for Forced Expiratory Volume in One Second (FEV1) Over 24 Hours (nAUC0-24B)
timeFrame: 24 hours following two weeks of dosing.
Secondary outcomes:
measure: Time-normalized Area From Study Baseline Curve for FEV1 Over 0-12 Hours (nAUC0-12B)
timeFrame: 0-12 hours following two weeks of dosing
measure: Time Normalized Area Under the Change From Study Baseline Curve for FEV1 Over 12-24 Hours (nAUC12-24B)
timeFrame: Following 2 weeks of dosing
measure: Change in FEV1 From Study Baseline to the 24-hour Timepoint (Trough)
timeFrame: Following 2 weeks of dosing
measure: Change in FEV1 From Study Baseline at Each Assessed Timepoint Post First Dose of Study Medication
timeFrame: 2 weeks
measure: Change in FEV1 Percent of Predicted From Study Baseline at Each Assessed Timepoint Post First Dose of Study Medication
timeFrame: 2 weeks
measure: Peak Change in FEV1 Over 12 Hours Post Dose From Study Baseline
timeFrame: 2 weeks
measure: Time to Onset in Participants Who Achieved a 10% Increase in FEV1 From Visit Predose After 2 Weeks
timeFrame: 2 weeks
measure: Time to Onset in Participants Who Achieved a 15% Increase in FEV1 From Visit Predose After 2 Weeks
timeFrame: 2 weeks
measure: Change in Inspiratory Capacity From Study Baseline to the 24 Hour Timepoint (Trough) Following 2 Weeks of Dosing
timeFrame: 2 weeks
measure: Change in Forced Vital Capacity (FVC) From Study Baseline at Each Assessed Post Dose Timepoint
timeFrame: 2 Weeks
measure: Levalbuterol Metered Dose Inhaler (MDI) (Rescue Medication) Use in Days Per Week
timeFrame: 2 weeks
measure: Levalbuterol Metered Dose Inhaler (MDI) Rescue Medication Use in Actuations Per Day
timeFrame: 2 weeks
measure: Transition Dyspnea Index (TDI) Focal Score
timeFrame: 2 weeks
measure: Number of Participants With a >= 1 Unit of Improvement in the TDI Focal Score
timeFrame: 2 weeks
measure: Percentage of Participants With a >=1 Unit Improvement in Transition Dysnea Index (TDI) Focal Score
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Jasper
country: United States
state: Alabama
city: Tucson
country: United States
state: Arizona
city: San Diego
country: United States
state: California
city: Colorado Springs
country: United States
state: Colorado
city: DeFuniak Springs
country: United States
state: Florida
city: DeLand
country: United States
state: Florida
city: Topeka
country: United States
state: Kansas
city: Hazard
country: United States
state: Kentucky
city: Madisonville
country: United States
state: Kentucky
city: Marrero
country: United States
state: Louisiana
city: Sunset
country: United States
state: Louisiana
city: Ann Arbor
country: United States
state: Michigan
city: Kalamazoo
country: United States
state: Michigan
city: St. Charles
country: United States
state: Missouri
city: Charlotte
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Eugene
country: United States
state: Oregon
city: Medford
country: United States
state: Oregon
city: Portland
country: United States
state: Oregon
city: E. Providence
country: United States
state: Rhode Island
city: Lincoln
country: United States
state: Rhode Island
city: Columbia
country: United States
state: South Carolina
city: Simpsonville
country: United States
state: South Carolina
city: Spartanburg
country: United States
state: South Carolina
city: Knoxville
country: United States
state: Tennessee
city: Tacoma
country: United States
state: Washington
city: Morgantown
country: United States
state: West Virginia
Study officials:
affiliation: Sumitomo Pharma America, Inc.
name: William Andrews, M.D.
role: STUDY_DIRECTOR
References:
citation: 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.