Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
Differentiating the Effects of Substance P and Beta-endorphin in the Perception of Breathlessness During Resistive Load Breathing in Patients With Chronic Obstructive Pulmonary Disease (COPD)
NCT number | NCT01854177 |
Other study ID # | CPHS#23992 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 2013 |
Est. completion date | November 2013 |
Verified date | August 2018 |
Source | Dartmouth-Hitchcock Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
In previous studies we demonstrated that endogenous opioids (inhibitory neuropeptides)
modulate the perception of breathing difficulty in patients with chronic obstructive
pulmonary disease (COPD). Recently, we found that antagonism of substance P (an excitatory
neuropeptide) with aprepitant did not affect the perception of breathing difficulty. However,
after administration of aprepitant, blood levels of both substance P(+ 54 ± 39%) and
beta-endorphin (+ 27 ± 17%) increased significantly. As these blood levels reflect
cellular/tissue activity, we postulated that the concomitant release of excitatory (substance
P) and inhibitory (beta-endorphin) neuropeptides had opposing effects (counterbalanced each
other) on the perception of breathing difficulty.
The objective of the present study is to further examine the possible role of substance P on
the perception of breathlessness. We propose to administer oral aprepitant and oral placebo
in a randomized clinical trial in patients with COPD. However, four hours after patients take
these medications, intravenous naloxone will be administered in order to block the effects of
endogenous opioids (beta-endorphin) on opioid receptors. Five minutes later, patients will
breathe thru a tube with fine wire mesh to provoke breathing difficulty, and then provide
ratings of the intensity and unpleasantness of breathlessness every minute.
The two competing hypothesis of the study are:
1. if breathlessness ratings with aprepitant/naloxone = placebo/naloxone, then substance P
has no effect on perception of breathing difficulty;
2. if breathlessness ratings with aprepitant/naloxone ≠ placebo/naloxone, then substance P
has an effect on perception of breathing difficulty.
Status | Completed |
Enrollment | 10 |
Est. completion date | November 2013 |
Est. primary completion date | November 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years to 90 Years |
Eligibility |
Inclusion Criteria: - male or female patient 50 years of age or older - a diagnosis of COPD; former smoker with a history of greater than or equal to 10 pack-years - a clinical diagnosis of chronic bronchitis (productive cough on most days for a minimum of three months per year for at least two successive years) - a post-bronchodilator forced expiratory volume in one second (FEV1) greater than or equal to 30% predicted and less than or equal to 80% predicted - a post-bronchodilator FEV1/forced vital capacity (FVC) ratio less than 70%; and clinically stable COPD. Exclusion Criteria: - current smoker - pregnant women - current or previous (within the past two weeks) use or of a narcotic medication - any patient who has a concomitant disease that might interfere with study procedures or evaluation including lactose intolerance - use of a drug that may cause possible drug interaction with aprepitant [including cilostazol, dofetilide, ergot alkaloids, oral or non-oral contraceptives, progestins, ranolazine, reboxetine, warfarin, ziprasidone, anxiolytic medications, anti-depressive medications, cholesterol lowering drugs (e.g., atorvastatin, simvastatin), theophylline, antifungal antibiotics, and macrolide antibiotics] - use of a contraindicated medication including astemizole, cisapride, pimozide, and terfenadine; - use of angiotensin converting enzyme inhibitor |
Country | Name | City | State |
---|---|---|---|
United States | Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire |
Lead Sponsor | Collaborator |
---|---|
Dartmouth-Hitchcock Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Unpleasantness of Breathlessness | Unpleasantness of breathlessness was reported each minute by the patient on a visual analog scale. The scale range is 0-10 where 0 = No breathlessness and 10 = Severe breathlessness. The measures were collected up to 20 minutes per visit and combined for a final score. Total minimum score = 0, total maximum score 200. Data is collected during Resistive Load Breathing at Period 1 (Day 3 or 4) and Period 2 (Day 5, 6 or 7) during which either Placebo or Aprepitant was administered. A high unpleasantness indicates that breathing difficulty feels very bad or terrifying regardless of whether the intensity is high or low | Visit 2 (Approximately Day 3 where either Placebo or Aprepitant was administered).and Visit 3 (approximately Day 6 where either Placebo or Aprepitant was administered) | |
Primary | Intensity of Breathlessness | Intensity of Breathlessness was recorded on a visual analog scale. The scale range is 0-10 where 0 = minimum and 10 = maximal intensity. At each visit, participants were asked to report unpleasantness at 1 minute intervals. The measures were collected up to 20 minutes per visit and combined for a final score. Total minimum score = 0, total maximum score 200. Data is collected during Resistive Load Breathing at Period 1 (Day 3 or 4) and Period 2 (Day 5, 6 or 7) during which either Placebo or Aprepitant was administered. | Visit 2 (Approximately Day 3 where either Placebo or Aprepitant was administered).and Visit 3 (approximately Day 6 where either Placebo or Aprepitant was administered) |
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