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

NCT01580423 | Completed Results DMC

• 1 other identifier: CPHS23276
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

dyspnea

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• 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)

Study Arms (2)

aprepitant

EXPERIMENTAL

Drug: aprepitant

inert powder

PLACEBO COMPARATOR

Drug: placebo

Interventions

aprepitant DRUG

125 mg capsule

aprepitant

placebo DRUG

capsule identical to aprepitant

inert powder

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• current smoker
• pregnant women
• concomitant disease that might interfere with study procedures
• peripheral vascular disease or cold hypersensitivity
• drugs that might interfere with aprepitant

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756-0001, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Dyspnea

Interventions

Aprepitant

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

1. single dose of aprepitant used 2. clinical diagnosis of chronic bronchitis phenotype of chronic obstructive pulmonary disease

Results Point of Contact

• Title: Donald A. Mahler
• Organization: Dartmouth-Hitchcock Medical Center

Donald.a.mahler@hitchcock.org

603 650-5533

Study Officials

• Donald A Mahler, MD

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2012
• First Posted: April 19, 2012
• Study Start: April 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: July 19, 2013
• Results First Posted: July 19, 2013

Record last verified: 2013-05

Locations

US (1)