Status:
COMPLETED
Differentiating the Effects of Substance P and Beta-endorphin
Lead Sponsor:
Dartmouth-Hitchcock Medical Center
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
50-90 years
Phase:
NA
Brief Summary
In previous studies we demonstrated that endogenous opioids (inhibitory neuropeptides) modulate the perception of breathing difficulty in patients with chronic obstructive pulmonary disease (COPD). Re...
Detailed Description
This study is a randomized, controlled clinical trial comparing the acute effects of oral aprepitant (selective antagonist of substance P receptor) vs. placebo on ratings of breathlessness during resi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01854177
Start Date
July 1 2013
End Date
November 1 2013
Last Update
October 30 2018
Active Locations (1)
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1
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756-0001