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
  Purpose

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.


Condition Intervention
Chronic Obstructive Pulmonary Disease
Drug: aprepitant
Drug: placebo

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
Official Title: The Role of Substance P on Perception of Breathlessness

Resource links provided by NLM:


Further study details as provided by Dartmouth-Hitchcock Medical Center:

Primary Outcome Measures:
  • 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".



Secondary Outcome Measures:
  • 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.



Enrollment: 16
Study Start Date: April 2012
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: aprepitant Drug: aprepitant
125 mg capsule
Placebo Comparator: inert powder Drug: placebo
capsule identical to aprepitant

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01580423

Locations
United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756-0001
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Investigators
Principal Investigator: Donald A Mahler, MD Dartmouth-Hitchcock Medical Center
  More Information

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

Keywords provided by Dartmouth-Hitchcock Medical Center:
dyspnea

Additional relevant MeSH terms:
Dyspnea
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Substance P
Aprepitant
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents

ClinicalTrials.gov processed this record on April 16, 2014