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Completed

NCT Number: NCT01580423

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

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Dyspnea Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756-0001, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aprepitant

Drug

125 mg capsule

Placebo

Drug

capsule identical to aprepitant

Primary outcomes

  1. 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)

    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".

  2. 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)

    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 outcomes

  1. 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)

    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.

Sponsors and collaborators

Lead sponsor

Dartmouth-Hitchcock Medical Center

Other

Registry information

Official study title

The Role of Substance P on Perception of Breathlessness

Acronym: SP-RLB

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Apr 19, 2012
Registry last updated
Jul 19, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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