Role of Endorphins in Perception of Dyspnea With Resistive Loading in Chronic Obstructive Pulmonary Disease (COPD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:
NCT00958919
First received: August 13, 2009
Last updated: March 1, 2013
Last verified: March 2013
Results First Received: November 5, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Chronic Obstructive Pulmonary Disease
Interventions: Drug: naloxone
Drug: normal saline

  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
March 2009 - June 2010; medical center

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
17 subjects recruited; 3 subjects excluded (2 did not meet inclusion criteria; 1 refused participation after signing consent).

Reporting Groups
  Description
Normal Saline First, Then Naloxone Intravenous saline (25 ml) in first intervention period and intravenous Naloxone (10mg/25 ml) in second intervention period.
Naloxone First, Then Normal Saline Intravenous Naloxone (10mg/25 ml)in first intervention period and intravenous saline (25 ml) in second intervention period.

Participant Flow for 2 periods

Period 1:   First Intervention
    Normal Saline First, Then Naloxone     Naloxone First, Then Normal Saline  
STARTED     7     7  
COMPLETED     7     7  
NOT COMPLETED     0     0  

Period 2:   Second Intervention
    Normal Saline First, Then Naloxone     Naloxone First, Then Normal Saline  
STARTED     7     7  
COMPLETED     7     7  
NOT COMPLETED     0     0  



  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
Entire Study Population Includes groups randomized to receive saline first and Naxolone first.

Baseline Measures
    Entire Study Population  
Number of Participants  
[units: participants]
  14  
Age  
[units: years]
Mean ± Standard Deviation
  64  ± 9  
Gender  
[units: participants]
 
Female     8  
Male     6  
Region of Enrollment  
[units: participants]
 
United States     14  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Intensity of Breathlessness   [ Time Frame: At 1 minute intervals during Resistive Load Breathing at Period 1 (Day 3 or 4) and Period 2 (Day 5, 6 or 7) ]

2.  Primary:   Unpleasantness of Breathlessness   [ Time Frame: At 1 minute intervals during Resistive Load Breathing at Period 1 (Day 3 or 4) and Period 2 (Day 5, 6 or 7) ]

3.  Secondary:   Endurance Time   [ Time Frame: Period 1 (Day 3 or 4) and Period 2 (Day 5, 6 or 7) ]

4.  Secondary:   Change in Level of B-endorphin Immunoreactivity During Naloxone Intervention   [ Time Frame: Baseline and at the end of Resistance Load Breathing during either Period 1 (Day 3 or 4) or Period 2 (Day 5, 6 or 7) depending on randomization ]

5.  Secondary:   Change in Level of B-endorphin Immunoreactivity During Saline Intervention   [ Time Frame: Baseline and at the end of Resistance Load Breathing during either Period 1 (Day 3 or 4) or Period 2 (Day 5, 6 or 7) depending on randomization ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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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.


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
No text entered.  


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


Publications of Results:

Responsible Party: Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT00958919     History of Changes
Other Study ID Numbers: 21721
Study First Received: August 13, 2009
Results First Received: November 5, 2012
Last Updated: March 1, 2013
Health Authority: United States: Institutional Review Board