An interventional study of aprepitant and placebo in Chronic Obstructive Pulmonary Disease, sponsored by Dartmouth-Hitchcock Medical Center. Completed at 1 site in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2013-07-19.
Sponsored by Dartmouth-Hitchcock Medical Center · Not applicable, Interventional, and Basic science
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.
2,592 studies on the registry are indexed under Lung Diseases, Obstructive; 198 are open to participants now.
This study's enrollment of 16 is below the median of 66 across 1,837 interventional studies indexed under Lung Diseases, Obstructive.
Browse Lung Diseases, Obstructive studies →Dartmouth-Hitchcock Medical Center is the lead sponsor of 472 studies on the registry; 68 are open to participants now.
Of its 30 completed or terminated interventional studies of FDA-regulated products, 20 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: aprepitant
Drug: placebo
125 mg capsule
capsule identical to aprepitant
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)
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)
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)
Dates of recruitment: April to October 2012; Location: medical clinic
| Milestone | First Aprepitant, Then Inert Powder | First Inert Powder, Then Aprepitant |
|---|---|---|
| Started | 8 | 8 |
| Completed | 8 | 8 |
| Not completed | 0 | 0 |
| Milestone | First Aprepitant, Then Inert Powder | First Inert Powder, Then Aprepitant |
|---|---|---|
| Started | 8 | 8 |
| Completed | 8 | 8 |
| Not completed | 0 | 0 |
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".
| units on a scale | Aprepitant | Inert Powder |
|---|---|---|
| Intensity of Breathlessness | 80.8 ± 13.5 | 77.9 ± 14.5 |
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.
| units on a scale | Aprepitant | Inert Powder |
|---|---|---|
| Intensity of Pain | 85.8 ± 16.2 | 81.9 ± 14.8 |
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".
| units on a scale | Aprepitant | Inert Powder |
|---|---|---|
| Unpleasantness of Breathlessness | 76.2 ± 16.7 | 72.2 ± 20.3 |
Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Aprepitant | — | 0/16 (0%) | 0/16 (0%) |
| Inert Powder | — | 0/16 (0%) | 0/16 (0%) |
| Age, Categorical(Participants) | Entire Study Population |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 11 |
| >=65 years | 5 |
| Age Continuous(years) | Entire Study Population |
|---|---|
| Mean | 70.2 ± 6.1 |
| Sex: Female, Male(Participants) | Entire Study Population |
|---|---|
| Female | 5 |
| Male | 11 |
| Region of Enrollment(participants) | Entire Study Population |
|---|---|
| United States | 16 |
This study is completed, as verified in May 2013. You cannot join it, but the record below documents what was studied.
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Dartmouth-Hitchcock Medical Center