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

Study Overview
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Brief Summary
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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.

Official Title
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The Role of Substance P on Perception of Breathlessness

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Drug: aprepitant
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: aprepitant<br> | Drug: aprepitant<br>* 125 mg capsule<br>|
| Placebo Comparator: inert powder<br> | Drug: placebo<br>* capsule identical to aprepitant<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | At 1 minute intervals during Resistive Load Breathing at Period 1 (Day 3 or 4) and Period 2 (Day 5, 6 or 7) | 
| 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. | 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 Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dyspnea