Text Size

Efficacy Safety Study of Arformoterol QD Dosing Versus BID Dosing in COPD

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sunovion
ClinicalTrials.gov Identifier:
NCT00571428
First received: December 10, 2007
Last updated: February 21, 2012
Last verified: February 2012
History of Changes
Results First Received: March 13, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Chronic Obstructive Pulmonary Disease
Interventions: Drug: Arformoterol Tartrate Inhalation Solution
Drug: Placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
15 Mcg BID / 30 Mcg QD Arformoterol 15 mcg twice a day (morning and evening) for one visit followed by Arformoterol 30 mcg once a day (morning) and placebo (evening) for the next visit.
30 Mcg QD / 15 Mcg BID Arformoterol 30 mcg once a day (morning) and placebo (evening) for one visit followed by Arformoterol 15 mcg twice a day (morning and evening) for the next visit.

Participant Flow:   Overall Study
    15 Mcg BID / 30 Mcg QD     30 Mcg QD / 15 Mcg BID  
STARTED     15     18  
COMPLETED     15     18  
NOT COMPLETED     0     0  



  Baseline Characteristics
  Hide Baseline Characteristics

Reporting Groups
  Description
15 Mcg BID / 30 Mcg QD Arformoterol 15 mcg twice a day (morning and evening) for one visit followed by Arformoterol 30 mcg once a day (morning) and placebo (evening) for the next visit.
30 Mcg QD / 15 Mcg BID Arformoterol 30 mcg once a day (morning) and placebo (evening) for one visit followed by Arformoterol 15 mcg twice a day (morning and evening) for the next visit.
Total Total of all reporting groups

Baseline Measures
    15 Mcg BID / 30 Mcg QD     30 Mcg QD / 15 Mcg BID     Total  
Number of Participants  
[units: participants]
 		  15     18     33  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     7     7     14  
>=65 years     8     11     19  
Age  
[units: Years]
Mean ± Standard Deviation 		  63.9  ± 9.3     64.9  ± 8.7     64.5  ± 8.8  
Gender  
[units: participants]
 		     
Female     6     7     13  
Male     9     11     20  
Race (NIH/OMB)  
[units: participants]
 		     
American Indian or Alaska Native     0     0     0  
Asian     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     2     2     4  
White     13     16     29  
More than one race     0     0     0  
Unknown or Not Reported     0     0     0  
Inhaled Corticosteroid Use at Baseline [1]
[units: participants]
 		     
Yes     1     4     5  
No     14     14     28  
Participants Categorized by the Number of Pack Years Smoked [2]
[units: participants]
 		     
>=15 years - <25 years     1     2     3  
>=25 years - < 30 years     0     3     3  
>=30 years     14     13     27  
Participants Categorized by the Number of Packs Currently Smoked per Day [3]
[units: participants]
 		     
>0 -1 pack     5     4     9  
>1 -2 packs     3     3     6  
>2 - 4 packs     0     0     0  
> 4 packs     0     0     0  
Currently does not smoke     7     11     18  
[1] This measure answers the question: Does the patient use a corticosteroid inhaler at the baseline visit?
[2] Pack years smoked is a way to measure the amount a person has smoked over a long period of time. It is calculated by taking the number of cigarettes smoked per day times the the number of years smoked divided by 20 (cigarettes per pack).
[3] This measure gives an indication of the quantity of cigarettes currently smoked per day.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Time-Normalized Area Under the Change From Pre-Dose Curve for Forced Expiratory Volume in One Second Measured Over 24 Hours   [ Time Frame: 0-24 hours post dose ]
  Show Outcome Measure 1

2.  Secondary:   Time-Normalized Area Under the Change From Pre-Dose Curve for Forced Expiratory Volume in One Second Measured Over 12 Hours   [ Time Frame: 0-12 hours ]
  Show Outcome Measure 2

3.  Secondary:   Time-Normalized Area Under the Change From Pre-Dose Curve for Forced Expiratory Volume in One Second Measured Between 12-24 Hours   [ Time Frame: 12-24 hours ]
  Show Outcome Measure 3

4.  Secondary:   Change in Forced Expiratory Volume in One Second From Pre-dose to the 24 Hour Time Point   [ Time Frame: pre-dose and 24 hours post-dose ]
  Show Outcome Measure 4

5.  Secondary:   Forced Expiratory Volume in One Second Measurements Pre-dose and at Each Assessed Time Point Post-dose   [ Time Frame: pre-dose, immediately post-dose, 30 min, 1,2,4,6,8,10,12, 12.5,13,14,16,23,24 hours post first dose ]
  Show Outcome Measure 5

6.  Secondary:   Change in Forced Expiratory Volume in One Second From Pre-dose To Each Assessed Time Point Post-Dose   [ Time Frame: Immediately post first dose, 30 min, 1,2,4,6,8,10,12,12.5,13,14,16,23,24 hours post first dose ]
  Show Outcome Measure 6

7.  Secondary:   Percent of Predicted Forced Expiratory Volume at One Second at Pre-dose and Each Assessed Time Point Post-Dose   [ Time Frame: Pre-dose, Immediately post first dose, 30 min, 1,2,4,6,8,10,12,12.5,13,14,16,23,24 hours post first dose ]
  Show Outcome Measure 7

8.  Secondary:   Change in Percent of Predicted Forced Expiratory Volume at One Second (FEV1) at Each Assessed Time Point Post-Dose Compared to Pre-Dose   [ Time Frame: Immediately post first dose, 30 min, 1,2,4,6,8,10,12,12.5,13,14,16,23,24 hours post first dose ]
  Show Outcome Measure 8

9.  Secondary:   Peak Percent of Predicted Forced Expiratory Volume at One Second (FEV1) Over 12 Hours Post-Dose.   [ Time Frame: 12 hours ]
  Show Outcome Measure 9

10.  Secondary:   Peak Change in Forced Expiratory Volume at One Second (FEV1) Within 12 Hours Post Dose Compared to Pre-dose   [ Time Frame: 12 hours ]
  Show Outcome Measure 10

11.  Secondary:   Time to Onset of 15 Percent Response Within 12 Hours of Dosing   [ Time Frame: 12 hours post first dose ]
  Hide Outcome Measure 11

Measure Type Secondary
Measure Title Time to Onset of 15 Percent Response Within 12 Hours of Dosing
Measure Description Time to a 15 percent improvement in forced expiratory volume in one second (FEV1) within 12 hours of dosing. Only patients who achieved at least a 15 percent improvement are included.
Time Frame 12 hours post first dose  
Safety Issue No  

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.
Intent to treat population. Limited to those patients who had a 15% response.

Reporting Groups
  Description
15 Mcg BID Arformoterol 15 mcg twice a day (morning and evening)
30 Mcg QD Arformoterol 30 mcg once a day (morning) and placebo (evening)

Measured Values
    15 Mcg BID     30 Mcg QD  
Number of Participants Analyzed  
[units: participants]
 		  20     25  
Time to Onset of 15 Percent Response Within 12 Hours of Dosing  
[units: minutes]
Median ( Full Range ) 		  7.75  
  ( 1.26 to 111.28 )   		  2.43  
  ( 1.13 to 692.29 )  

No statistical analysis provided for Time to Onset of 15 Percent Response Within 12 Hours of Dosing



12.  Secondary:   Time to Onset of Response of Both a 12 Percent Increase and 200 Milliliter Increase Within 12 Hours of Dosing   [ Time Frame: up to 12 hours post dose ]
  Show Outcome Measure 12

13.  Secondary:   Time to Onset of Response of Both a 12 Percent Increase and 200 Milliliter Increase in Forced Expiratory Volume in One Second Within 12 Hours of Dosing   [ Time Frame: pre-dose, immediately post first dose, 30 min, 1,2,4,6,8,10,12, 12.5, 13, 14, 16, 23,24 hours post first dose ]
  Show Outcome Measure 13

14.  Secondary:   Change in Forced Vital Capacity From Pre-dose to Each Post-Dose Assessed Time Point   [ Time Frame: immediately post first dose, 30 min, 1,2,4,6,8,10,12, 12.5, 13, 14, 16, 23,24 hours post first dose ]
  Show Outcome Measure 14


  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
  Show Other Adverse Events


  More Information
  Hide More Information

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.


Limitations and Caveats
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
Single day/dose; small numbers of subjects; difference between arms (2mL vs 4mL per dose); Predefined +/-0.07L equivalence is arbitrarily lower than the clinically recognized 0.1L. Hence, clinical efficacy & safety conclusions are difficult to reach.  


Results Point of Contact:  
Name/Title: Brovana Medical Director
Organization: Sunovion
phone: 1-866-503-6351


No publications provided by Sunovion

Publications automatically indexed to this study:


Responsible Party: Sunovion
ClinicalTrials.gov Identifier: NCT00571428     History of Changes
Other Study ID Numbers: 091-903
Study First Received: December 10, 2007
Results First Received: March 13, 2009
Last Updated: February 21, 2012
Health Authority: United States: Food and Drug Administration