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

Chronic Obstructive Pulmonary Disease Clinical Trial

— SP-RLB  

Official title:

The Role of Substance P on Perception of Breathlessness

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01580423
• Other study ID #: CPHS23276
• Status: Completed
• Phase: N/A
• First received: April 16, 2012
• Last updated: May 24, 2013
• Start date: April 2012
• Est. completion date: March 2013

Study information

• Verified date: May 2013
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Dyspnea
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• aprepitant
125 mg capsule
• placebo
capsule identical to aprepitant

Locations

Country	Name	City	State
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire

Sponsors (1)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Primary	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)	No
Secondary	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)	No