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The Role of Substance P on Perception of Breathlessness During Resistive Load Breathing (SP-RLB)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:
NCT01580423
First received: April 16, 2012
Last updated: May 24, 2013
Last verified: May 2013
Results First Received: May 24, 2013  
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: Basic Science
Condition: Chronic Obstructive Pulmonary Disease
Interventions: Drug: aprepitant
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
Dates of recruitment: April to October 2012; Location: medical clinic

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
17 subjects recruited; 1 patient who signed the consent form did not meet inclusion/exclusion criteria, and no testing was performed.

Reporting Groups
  Description
First Aprepitant, Then Inert Powder Capsule of aprepitant 125 mg in first intervention period and capsule of inert powder in second intervention period.
First Inert Powder, Then Aprepitant Capsule of inert powder in first intervention period and capsule of aprepitant 125 mg in second intervention period.

Participant Flow for 2 periods

Period 1:   First Intervention
    First Aprepitant, Then Inert Powder     First Inert Powder, Then Aprepitant  
STARTED     8     8  
COMPLETED     8     8  
NOT COMPLETED     0     0  

Period 2:   Second Intervention
    First Aprepitant, Then Inert Powder     First Inert Powder, Then Aprepitant  
STARTED     8     8  
COMPLETED     8     8  
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 aprepitant first and inert powder first.

Baseline Measures
    Entire Study Population  
Number of Participants  
[units: participants]
  16  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     11  
>=65 years     5  
Age  
[units: years]
Mean ± Standard Deviation
  70.2  ± 6.1  
Gender  
[units: participants]
 
Female     5  
Male     11  
Region of Enrollment  
[units: participants]
 
United States     16  



  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:   Intensity of Pain   [ Time Frame: Every 15 seconds during immersion of hand in cold water for up to 5 minutes at Period 1 (Day 3 or 4) and Period 2 (Day 5, 6 or 7) ]


  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
  1. single dose of aprepitant used
  2. clinical diagnosis of chronic bronchitis phenotype of chronic obstructive pulmonary disease


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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


No publications provided


Responsible Party: Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT01580423     History of Changes
Other Study ID Numbers: CPHS23276
Study First Received: April 16, 2012
Results First Received: May 24, 2013
Last Updated: May 24, 2013
Health Authority: United States: Institutional Review Board