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

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
aprepitant
placebo
Sponsored by
Dartmouth-Hitchcock Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Chronic Obstructive Pulmonary Disease focused on measuring dyspnea

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dartmouth-Hitchcock Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

aprepitant

inert powder

Arm Description

Outcomes

Primary Outcome Measures

Intensity of Breathlessness
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-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".

Secondary Outcome Measures

Intensity of Pain
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.

Full Information

First Posted
April 16, 2012
Last Updated
May 24, 2013
Sponsor
Dartmouth-Hitchcock Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01580423
Brief Title
The Role of Substance P on Perception of Breathlessness During Resistive Load Breathing
Acronym
SP-RLB
Official Title
The Role of Substance P on Perception of Breathlessness
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dartmouth-Hitchcock Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
dyspnea

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
aprepitant
Arm Type
Experimental
Arm Title
inert powder
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
aprepitant
Intervention Description
125 mg capsule
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
capsule identical to aprepitant
Primary Outcome Measure Information:
Title
Intensity of Breathlessness
Description
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".
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)
Title
Unpleasantness of Breathlessness
Description
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".
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)
Secondary Outcome Measure Information:
Title
Intensity of Pain
Description
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.
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donald A Mahler, MD
Organizational Affiliation
Dartmouth-Hitchcock Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756-0001
Country
United States

12. IPD Sharing Statement

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The Role of Substance P on Perception of Breathlessness During Resistive Load Breathing

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