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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2013-03-31

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.

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Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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aprepitant

Group Type EXPERIMENTAL

aprepitant

Intervention Type DRUG

125 mg capsule

inert powder

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

capsule identical to aprepitant

Interventions

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aprepitant

125 mg capsule

Intervention Type DRUG

placebo

capsule identical to aprepitant

Intervention Type DRUG

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

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No