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

Not Applicable

Completed

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Drug: placebo; Drug: aprepitant

• Registration Number: NCT01580423
• Lead Sponsor: Dartmouth-Hitchcock Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-04-16
• Study First Submitted QC: 2012-04-18
• Study First Posted: 2012-04-19
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2013-05
• Results First Submitted: 2013-05-24
• Results First Submitted QC: 2013-05-24
• Last Update Submitted: 2013-05-24
• Results First Posted: 2013-07-19
• Last Update Posted: 2013-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
inert powder	placebo	-
aprepitant	aprepitant	-

Primary Outcome Measures

Name	Time	Method
Intensity of Breathlessness	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".
Unpleasantness of Breathlessness	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 Outcome Measures

Name	Time	Method
Intensity of Pain	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.

Trial Locations

Locations (1)

Dartmouth-Hitchcock Medical Center; 🇺🇸 Lebanon, New Hampshire, United States