ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Bronchodilation on Cycle vs Treadmill Exercise Endurance Time in COPD (ARFEET)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00754546
Recruitment Status : Completed
First Posted : September 18, 2008
Results First Posted : May 29, 2013
Last Update Posted : May 29, 2013
Sponsor:
Collaborator:
Sunovion
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Chronic Obstructive Pulmonary Disease
Interventions: Drug: Arformoterol tartrate
Drug: Placebo: Normal Saline
Other: Treadmill Exercise
Other: Cycle Exercise

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants recruited from a specialty clinic in Lebanon, NH, between August 1, 2008 to May 1, 2009.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
27 particpants recruited; 27 particpants screened; 5 excluded because they did not meet inclusion criteria; 2 patients withdrew consent after visit 1.

Reporting Groups
  Description
All Participants

All 20 participants were randomized to receive all 4 of the interventions in a randomzied sequence. The 4 interventions follow:

Treadmill exercise-Arformoterol Treadmill exercise-Normal Saline Cycle exercise-Arformoterol Cycle exercise-Normal Saline


Participant Flow:   Overall Study
    All Participants
STARTED   20 
COMPLETED   20 
NOT COMPLETED   0 



  Baseline Characteristics

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
All Participants

All 20 participants were randomized to receive all 4 of the interventions in a randomzied sequence. The 4 interventions follow:

Treadmill exercise-Arformoterol Treadmill exercise-Normal Saline Cycle exercise-Arformoterol Cycle exercise-Normal Saline


Baseline Measures
   All Participants 
Overall Participants Analyzed 
[Units: Participants]
 20 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   12 
>=65 years   8 
Age 
[Units: Years]
Mean (Standard Deviation)
 64  (7) 
Gender 
[Units: Participants]
 
Female   9 
Male   11 
Region of Enrollment 
[Units: Participants]
 
United States   20 


  Outcome Measures

1.  Primary:   Exercise Endurance Time   [ Time Frame: After one dose ]

2.  Secondary:   Linear Regression Between Breathlessness Ratings (on 0 - 10 Borg Scale) and Time Throughout Exercise   [ Time Frame: After one dose ]


  Serious Adverse Events


  Other Adverse Events


  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
Study completed with no reported adverse effects. One limitation of the study is frequent exercise tests involving 7 visits for each participant


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Donald A. Mahler, M.D.
Organization: Dartmouth-Hitchcock Medical Center
phone: 603 650-5533
e-mail: Donald.a.mahler@hitchcock.org


Publications of Results:

Responsible Party: Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT00754546     History of Changes
Other Study ID Numbers: 21261
First Submitted: September 16, 2008
First Posted: September 18, 2008
Results First Submitted: August 3, 2009
Results First Posted: May 29, 2013
Last Update Posted: May 29, 2013