Exhaled NO Based Treatment of Chronic Obstructive Pulmonary Disease (COPD), ICS/LABA Versus LAMA
Status:
Unknown status
Trial end date:
2016-01-01
Target enrollment:
Participant gender:
Summary
It is recognized that eosinophilic airway inflammation is more likely respond to steroid
treatment. However, in real-world practice, it is difficult to routinely assess airway
inflammation using sputum induction because of technical and facility requirement. COPD
(chronic obstructive pulmonary disease) is a heterogeneous disease and it remains a great
challenge to identify patients who have eosinophilic airway inflammation and respond to
steroid treatment well. A recent study demonstrated elevated plasma D-dimer was associated
with acute inflammation and a significant predictor of pulmonary embolism in COPD exacerbated
patients. D-dimer may potentially act as a marker of inflammation and a predictor of
cardiovascular event in COPD patients. The investigators preliminary study demonstrated that
exhaled nitric oxide (eNO) > 23.5 ppb is a good surrogate marker to predict eosinophilic
airway inflammation in COPD patients who were newly diagnosed or untreated for at least 3
months. There were significant correlations among sputum eosinophils, eNO and serum total
immunoglobulin E (IgE). Particularly, eNO predicted sputum eosinophilia (> 3%) in COPD at a
sensitivity and specificity of 62% and 71% respectively. Herein, the investigators test the
hypothesis that eNO may act as a biomarker to determine treatment option for COPD.
Phase:
Phase 4
Details
Lead Sponsor:
Taipei Veterans General Hospital, Taiwan
Collaborator:
GlaxoSmithKline
Treatments:
Fluticasone Fluticasone Propionate, Salmeterol Xinafoate Drug Combination Fluticasone-Salmeterol Drug Combination Nitric Oxide Salmeterol Xinafoate Tiotropium Bromide