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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sunovion
ClinicalTrials.gov Identifier:
NCT00424528
First received: January 17, 2007
Last updated: May 29, 2012
Last verified: May 2012
Results First Received: October 24, 2008  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Conditions: Chronic Obstructive Pulmonary Disease
Bronchitis
Emphysema
Interventions: Drug: Arformoterol Tartrate Inhalation Solution
Drug: Tiotropium
Drug: Arformoterol and Tiotropium
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Multicenter (34 sites) study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Started: consists of all subjects who were randomized to treatment and received at least one dose of randomized study drug (Intent to treat population). One patient was randomized to the arformoterol/tiotropium group but discontinued before receiving any study medication and is therefore not included.

Reporting Groups
  Description
Arformoterol 15 Mcg Twice Daily Arformoterol 15 mcg twice daily/Placebo Inhalation Powder
Tiotropium 18 Mcg Once Daily Tiotropium 18 mcg once daily/Placebo Inhalation Solution
Arformoterol /Tiotropium Arformoterol 15 mcg twice daily/Tiotropium 18 mcg once daily

Participant Flow:   Overall Study
    Arformoterol 15 Mcg Twice Daily     Tiotropium 18 Mcg Once Daily     Arformoterol /Tiotropium  
STARTED     76     80     78  
COMPLETED     71     76     74  
NOT COMPLETED     5     4     4  
Adverse Event                 2                 1                 2  
Protocol Violation                 1                 1                 0  
Lost to Follow-up                 0                 1                 0  
noncompliance with study requirements                 2                 1                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Arformoterol 15 Mcg Twice Daily Arformoterol 15 mcg twice daily/Placebo Inhalation Powder
Tiotropium 18 Mcg Once Daily Tiotropium 18 mcg once daily/Placebo Inhalation Solution
Arformoterol /Tiotropium Arformoterol 15 mcg twice daily/Tiotropium 18 mcg once daily
Total Total of all reporting groups

Baseline Measures
    Arformoterol 15 Mcg Twice Daily     Tiotropium 18 Mcg Once Daily     Arformoterol /Tiotropium     Total  
Number of Participants  
[units: participants]
  76     80     78     234  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     47     50     52     149  
>=65 years     29     30     26     85  
Age  
[units: years]
Mean ± Standard Deviation
  61.6  ± 8.4     61.2  ± 9.5     62.2  ± 7.6     61.7  ± 8.5  
Gender  
[units: participants]
       
Female     37     37     36     110  
Male     39     43     42     124  
Race (NIH/OMB)  
[units: Participants]
       
American Indian or Alaska Native     0     0     1     1  
Asian     0     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0     0  
Black or African American     5     6     7     18  
White     71     74     70     215  
More than one race     0     0     0     0  
Unknown or Not Reported     0     0     0     0  
Region of Enrollment  
[units: participants]
       
United States     76     80     78     234  
Number of Pack Years Smoked [1]
[units: Participants]
       
>=15 years to <25 years     0     1     6     7  
>=25 years to <=30 years     4     4     4     12  
>=30 years     72     75     68     215  
Packs per day currently smoked [2]
[units: Participants]
       
>0 to 1 pack     24     30     22     76  
>1 to 2 packs     22     24     16     62  
>2 to 4 packs     3     0     1     4  
>4 packs     0     0     0     0  
Currently does not smoke     27     26     39     92  
Baseline Dyspnea Index (BDI) Focal Score [3]
[units: units on a scale]
Mean ± Standard Deviation
  5.8  ± 2.0     5.8  ± 1.9     5.5  ± 2.1     5.7  ± 2.0  
Best Forced Expiratory Volume in one second (FEV1)/Best Forced Vital Capacity (FVC) ratio  
[units: Liters]
Mean ± Standard Deviation
  0.510  ± 0.098     0.514  ± 0.107     0.525  ± 0.108     0.516  ± 0.104  
FEV1  
[units: Liters]
Mean ± Standard Deviation
  1.366  ± 0.457     1.377  ± 0.460     1.350  ± 0.408     1.365  ± 0.440  
FEV1 Percent Predicted  
[units: percent predicted of FEV1]
Mean ± Standard Deviation
  45.4  ± 11.9     45.7  ± 11.5     44.9  ± 12.0     45.4  ± 11.8  
Inspiratory Capacity  
[units: Liters]
Mean ± Standard Deviation
  2.005  ± 0.615     1.979  ± 0.555     1.924  ± 0.516     1.969  ± 0.562  
Modified Medical Research Council Dyspnea Questionnaire [4]
[units: units on a scale]
Mean ± Standard Deviation
  2.7  ± 0.6     2.9  ± 0.7     2.9  ± 0.6     2.8  ± 0.6  
[1] Number of participants with a particular range of pack years smoked.
[2] Number of participants with a particular range of packs per day currently smoked.
[3] Baseline Dyspnea Index(range 0-12) is defined to be the sum of the Functional Impairment, Magnitude of Task, and Magnitude of Effort scores (each on a 0-4 scale) obtained at visit 2 (baseline. On each scale, a high measurement represents the most impairment to health.
[4] The Dyspnea scale score reflects the highest numbered question to which the subject answered "yes" in a series of five questions, each describing progressively worse dyspnea. Scores range from 0 to 4, with a score of 4 indicating that a subject is too breathless to leave the house or becomes breathless when dressing or undressing.



  Outcome Measures
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1.  Primary:   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. ]

2.  Secondary:   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 ]

3.  Secondary:   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 ]

4.  Secondary:   Change in FEV1 From Study Baseline to the 24-hour Timepoint (Trough)   [ Time Frame: Following 2 weeks of dosing ]

5.  Secondary:   Change in FEV1 From Study Baseline at Each Assessed Timepoint Post First Dose of Study Medication   [ Time Frame: 2 weeks ]

6.  Secondary:   Change in FEV1 Percent of Predicted From Study Baseline at Each Assessed Timepoint Post First Dose of Study Medication   [ Time Frame: 2 weeks ]

7.  Secondary:   Peak Change in FEV1 Over 12 Hours Post Dose From Study Baseline   [ Time Frame: 2 weeks ]

8.  Secondary:   Time to Onset in Participants Who Achieved a 10% Increase in FEV1 From Visit Predose After 2 Weeks   [ Time Frame: 2 weeks ]

9.  Secondary:   Time to Onset in Participants Who Achieved a 15% Increase in FEV1 From Visit Predose After 2 Weeks   [ Time Frame: 2 weeks ]

10.  Secondary:   Change in Inspiratory Capacity From Study Baseline to the 24 Hour Timepoint (Trough) Following 2 Weeks of Dosing   [ Time Frame: 2 weeks ]

11.  Secondary:   Change in Forced Vital Capacity (FVC) From Study Baseline at Each Assessed Post Dose Timepoint   [ Time Frame: 2 Weeks ]

12.  Secondary:   Levalbuterol Metered Dose Inhaler (MDI) (Rescue Medication) Use in Days Per Week   [ Time Frame: 2 weeks ]

13.  Secondary:   Levalbuterol Metered Dose Inhaler (MDI) Rescue Medication Use in Actuations Per Day   [ Time Frame: 2 weeks ]

14.  Secondary:   Transition Dyspnea Index (TDI) Focal Score   [ Time Frame: 2 weeks ]

15.  Secondary:   Number of Participants With a >= 1 Unit of Improvement in the TDI Focal Score   [ Time Frame: 2 weeks ]

16.  Secondary:   Percentage of Participants With a >=1 Unit Improvement in Transition Dysnea Index (TDI) Focal Score   [ Time Frame: 2 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
As of October 24, 2008, Sepracor is unaware of any limitations or caveats associated with this study.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Respiratory Medical Affairs Director
Organization: Sepracor Inc
phone: 866-503-6351


No publications provided by Sunovion

Publications automatically indexed to this study:

Responsible Party: Sunovion
ClinicalTrials.gov Identifier: NCT00424528     History of Changes
Other Study ID Numbers: 091-902
Study First Received: January 17, 2007
Results First Received: October 24, 2008
Last Updated: May 29, 2012
Health Authority: United States: Food and Drug Administration