Phase 4 Completed N=20 Randomized Quadruple-blind Treatment

Effect of Ketoconazole on Breathlessness

Chronic Obstructive Pulmonary Disease

Source: ClinicalTrials.gov NCT01378520 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2013

Primary outcomePrimary: Unpleasantness of Breathlessness — 72.5; 72.6 units on a scale

Summary

Beta-endorphins, which are naturally occurring narcotic substances, have been shown to alter the perception of breathlessness. Oral ketoconazole, an antifungal antibiotic, increases blood levels of beta-endorphins. The study hypothesis is that oral ketoconazole will reduce ratings of breathlessness induced by resistive breathing loads.

Outcome Measures

Outcome	Result	p-value
PRIMARY Unpleasantness of Breathlessness	72.5; 72.6	—
PRIMARY Intensity of Breathlessness	77.6; 78.2	—
SECONDARY Change in Level of B-endorphin Immunoreactivity	153.9; 93.9	—

Eligibility Criteria

Inclusion Criteria

50 years of age or older;
diagnosis of COPD;
current or former smoker of at least 10 pack-years;
post-bronchodilator FEV1 greater than or equal to 30% predicted and less than or equal to 80% predicted; post-bronchodilator ratio < 70%

Exclusion Criteria

any concomitant disease that might interfere with study procedures;
use of a drug that may cause a possible drug interaction with ketoconazole

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01378520). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.