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

April 16, 2012
May 24, 2013
April 2012
March 2013   (final data collection date for primary outcome measure)
  • 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) ] [ Designated as safety issue: No ]

    Time-weighted averages of intensity of breathlessness.

    Subject rating of intensity of breathlessness was obtained at 1 minute intervals during RLB on a 100 mm Visual Analog Scale anchored at the bottom by "No Intensity" and at the top by "Greatest Intensity".

  • 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) ] [ Designated as safety issue: No ]

    Time-weighted averages of unpleasantness of breathlessness.

    Subject rating of unpleasantness of breathlessness was obtained at 1 minute intervals during RLB on a 100 mm Visual Analog Scale anchored at the bottom by "No Unpleasantness" and at the top by "Greatest Unpleasantness".

Ratings of breathlessness [ Time Frame: Up to 20 minutes ] [ Designated as safety issue: No ]
Intensity and unpleasantness of breathlessness on separate visual analog scales
Complete list of historical versions of study NCT01580423 on ClinicalTrials.gov Archive Site
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) ] [ Designated as safety issue: No ]

Time-weighted averages for intensity of pain.

Subject rating of intensity of pain on a 100 mm Visual Analog Scale anchored at the bottom by "No Intensity" and at the top by "Greatest Intensity" was obtained during immersion of the subject's non-dominant hand in cold water.

Ratings of pain [ Time Frame: Up to 20 minutes ] [ Designated as safety issue: No ]
Ratings of intensity and unpleasantness of pain during immersion of hand in cold water
Not Provided
Not Provided
 
The Role of Substance P on Perception of Breathlessness During Resistive Load Breathing
The Role of Substance P on Perception of Breathlessness

Substance P is released from sensory nerves and transmits pain information into the central nervous system. As pain and dyspnea share many characteristics, including similar neurological pathways, it is possible that substance P may contribute to the sensation of dyspnea. The hypothesis of the study is that patients with chronic obstructive pulmonary disease (COPD) will provide lower ratings of breathlessness during resistive load breathing with oral aprepitant, a medication that blocks the activity of substance P, compared with placebo.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Chronic Obstructive Pulmonary Disease
  • Drug: aprepitant
    125 mg capsule
  • Drug: placebo
    capsule identical to aprepitant
  • Experimental: aprepitant
    Intervention: Drug: aprepitant
  • Placebo Comparator: inert powder
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
March 2013
March 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 50 years of age or older
  • diagnosis of COPD
  • former smoker > 10 pack-years
  • clinical diagnosis of chronic bronchitis
  • post-bronchodilator forced expiratory volume in one second (FEV1) 30 - 80% predicted
  • FEV1/forced vital capacity ratio less than or equal to 70%

Exclusion Criteria:

  • current smoker
  • pregnant women
  • concomitant disease that might interfere with study procedures
  • peripheral vascular disease or cold hypersensitivity
  • drugs that might interfere with aprepitant
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01580423
CPHS23276
Yes
Dartmouth-Hitchcock Medical Center
Dartmouth-Hitchcock Medical Center
Not Provided
Principal Investigator: Donald A Mahler, MD Dartmouth-Hitchcock Medical Center
Dartmouth-Hitchcock Medical Center
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP