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

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Dartmouth Health

Status

Completed

Conditions

Chronic Obstructive Pulmonary Disease

Treatments

Drug: aprepitant
Drug: placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT01580423
CPHS23276

Details and patient eligibility

About

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.

Enrollment

16 patients

Sex

All

Ages

50+ years old

Volunteers

No 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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

16 participants in 2 patient groups, including a placebo group

aprepitant
Experimental group
Treatment:
Drug: aprepitant
inert powder
Placebo Comparator group
Treatment:
Drug: placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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