Chronic Obstructive Pulmonary Disease
Conditions
Keywords
dyspnea
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.
Interventions
DRUGaprepitant
125 mg capsule
DRUGplacebo
capsule identical to aprepitant
Sponsors
Dartmouth-Hitchcock Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Recruitment details
Dates of recruitment: April to October 2012; Location: medical clinic
Pre-assignment details
17 subjects recruited; 1 patient who signed the consent form did not meet inclusion/exclusion criteria, and no testing was performed.
Participants by arm
| Arm | Count |
|---|---|
| Entire Study Population Includes groups randomized to receive aprepitant first and inert powder first. | 16 |
| Total | 16 |
Baseline characteristics
| Characteristic | Entire Study Population |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 5 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants |
| Age Continuous | 70.2 years STANDARD_DEVIATION 6.1 |
| Region of Enrollment United States | 16 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 16 | 0 / 16 |
| serious Total, serious adverse events | 0 / 16 | 0 / 16 |
Outcome results
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.
Time frame: At 1 minute intervals during Resistive Load Breathing at Period 1 (Day 3 or 4) and Period 2 (Day 5, 6 or 7)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aprepitant | Intensity of Breathlessness | 80.8 units on a scale | Standard Deviation 13.5 |
| Inert Powder | Intensity of Breathlessness | 77.9 units on a scale | Standard Deviation 14.5 |
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.
Time frame: At 1 minute intervals during Resistive Load Breathing at Period 1 (Day 3 or 4) and Period 2 (Day 5, 6 or 7)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aprepitant | Unpleasantness of Breathlessness | 76.2 units on a scale | Standard Deviation 16.7 |
| Inert Powder | Unpleasantness of Breathlessness | 72.2 units on a scale | Standard Deviation 20.3 |
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.
Time frame: 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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aprepitant | Intensity of Pain | 85.8 units on a scale | Standard Deviation 16.2 |
| Inert Powder | Intensity of Pain | 81.9 units on a scale | Standard Deviation 14.8 |