Skip to main content
OpenTrials
Completed

NCT Number: NCT00424528

Efficacy Safety Study of Arformoterol/Tiotropium Combination Versus Either Therapy Alone in Chronic Obstructive Pulmonary Disease (COPD)

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Jasper, Alabama, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Arformoterol tartrate inhalation solution

Drug

Arformoterol tartrate inhalation solution 15 mcg twice daily and placebo inhalation powder once daily.

Other names: Brovana®

Tiotropium

Drug

Placebo inhalation solution twice daily and tiotropium inhalation powder 18 mcg once daily.

Other names: Spiriva

Arformoterol and Tiotropium

Drug

Arformoterol tartrate inhalation solution 15 mcg twice daily and Tiotropium inhalation powder 18 mcg once daily.

Other names: Brovana, Spiriva

Placebo

Drug

Placebo inhalation solution and placebo inhalation powder

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)

    Time frame: 24 hours following two weeks of dosing.

Secondary outcomes

  1. Time-normalized Area From Study Baseline Curve for FEV1 Over 0-12 Hours (nAUC0-12B)

    Time frame: 0-12 hours following two weeks of dosing

  2. Time Normalized Area Under the Change From Study Baseline Curve for FEV1 Over 12-24 Hours (nAUC12-24B)

    Time frame: Following 2 weeks of dosing

  3. Change in FEV1 From Study Baseline to the 24-hour Timepoint (Trough)

    Time frame: Following 2 weeks of dosing

    Trough FEV1 is defined as the measurement collected approximately 24 hours after the first in-clinic double-blind dose at Week 0. Change is calculated as Week 2 24 hour post first dose FEV1 - Week 0 pre-first dose FEV1.

  4. Change in FEV1 From Study Baseline at Each Assessed Timepoint Post First Dose of Study Medication

    Time frame: 2 weeks

    Baseline is FEV1 measurement collected prior to the first double-blind dose at week 0. Change defined as Week 0 FEV1 - Week 2 pre first dose FEV1.

  5. Change in FEV1 Percent of Predicted From Study Baseline at Each Assessed Timepoint Post First Dose of Study Medication

    Time frame: 2 weeks

    Baseline is FEV1 collected prior to first double-blind dose at week 0. Change is defined as Week 0 FEV1 percent predicted - Week 2 pre first dose FEV1 percent predicted.

  6. Peak Change in FEV1 Over 12 Hours Post Dose From Study Baseline

    Time frame: 2 weeks

    12 hour peak change in FEV1 is defined as maximum of the post dose changes through the nominal 12 hour assessment.

  7. Time to Onset in Participants Who Achieved a 10% Increase in FEV1 From Visit Predose After 2 Weeks

    Time frame: 2 weeks

    Analyzed from end of dosing to 12 hours.

  8. Time to Onset in Participants Who Achieved a 15% Increase in FEV1 From Visit Predose After 2 Weeks

    Time frame: 2 weeks

    Analyzed from end of dosing to 12 hours.

  9. Change in Inspiratory Capacity From Study Baseline to the 24 Hour Timepoint (Trough) Following 2 Weeks of Dosing

    Time frame: 2 weeks

    Trough Inspiratory Capacity is defined as the measurement collected approximately 24 hours after the first in clinic double-blind treatment dose at week 0. Change is calculated as Week 2 24 hr post dose IC - Week 0 pre first dose IC.

  10. Change in Forced Vital Capacity (FVC) From Study Baseline at Each Assessed Post Dose Timepoint

    Time frame: 2 Weeks

  11. Levalbuterol Metered Dose Inhaler (MDI) (Rescue Medication) Use in Days Per Week

    Time frame: 2 weeks

    Overall: Average of the levalbuterol usage in days per week over the 2 week period. Mean number of days/week=number of days levalbuterol used during time period, divided by number of days in the period, multiplied by 7. An actuation is one puff of levalbuterol.

  12. Levalbuterol Metered Dose Inhaler (MDI) Rescue Medication Use in Actuations Per Day

    Time frame: 2 weeks

    Overall: Average of the usage in number of actuations per day over the 2 week period. An actuation is one puff of levalbuterol. Mean number of actuations/day=number actuations used during time period, divided by number of days in time period.

  13. Transition Dyspnea Index (TDI) Focal Score

    Time frame: 2 weeks

    TDI Focal score (range -9 to 9) is defined as the sum of function impairment, magnitude of task, and magnitude of effort (each on a -3 to 3 scale). A score of -9 is maximum worsening and 9 is maximum improvement.

  14. Number of Participants With a >= 1 Unit of Improvement in the TDI Focal Score

    Time frame: 2 weeks

    A Greater than or Equal to 1 unit of Improvement in the TDI Focal Score is considered to be clinically important.

  15. Percentage of Participants With a >=1 Unit Improvement in Transition Dysnea Index (TDI) Focal Score

    Time frame: 2 weeks

    A Greater than or Equal to 1 unit of Improvement in the TDI Focal Score is considered to be clinically important.

Sponsors and collaborators

Lead sponsor

Sumitomo Pharma America, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Jan 19, 2007
Registry last updated
Jun 4, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.