Exhaled NO Based Treatment of Chronic Obstructive Pulmonary Disease (COPD), ICS/LABA Versus LAMA
COPD
About this trial
This is an interventional treatment trial for COPD focused on measuring chronic obstructive pulmonary disease, airway inflammation, eosinophilic airway inflammation, exhaled nitric oxide
Eligibility Criteria
Inclusion Criteria:
- Male or female outpatients aged from 40 to 90 years
- Current or ex-smoker, with smoking history ≧ 20 pack- years
- Newly diagnosed or untreated (at least 3 months) COPD patients (forced expiratory volume in first second (FEV1)/forced vital capacity (FVC) < 70%) with post-bronchodilator FEV1 < 80 % predicted value.
Exclusion Criteria:
- Concurrent allergic rhinitis, eczema, and asthma.
- Clinically overt bronchiectasis, lung cancer, active tuberculosis, or other known specific pulmonary disease.
- A chest X-ray indicating diagnosis other than COPD that might interfere with the study.
- Major disease abnormalities are uncontrolled on therapy.
- Alcohol or medication abuse.
- Patients had lower respiratory tract infections or received systemic steroid in the 4 weeks prior to the commencement of study.
- Women with childbearing potential during the period of trial.
- Unable or unwilling to comply with all protocol
Sites / Locations
- Taipei Veterans General Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Active Comparator
Experimental
Active Comparator
high eNO: ICS/LABA
high eNO: LAMA
Low eNO: ICS/LABA
Low eNO: LAMA
patients with eNO >=23.5 ppb, receive inhaled corticosteroid (ICS)/long-acting beta2 agonist (ICS/LABA) of fluticasone/salmeterol 250/25 mcg/puff, 2 puffs bid.
patients with eNO >=23.5 ppb, receive long acting muscarinic antagonist (LAMA) of tiotropium 2 inhalations 2.5 mcg/inhalation, once daily
patients with eNO < 23.5 ppb, receive fluticasone/salmeterol 250/25 mcg/puff, 2 puffs bid
patients with eNO < 23.5 ppb, receive tiotropium 2 inhalations 2.5 mcg/inhalation, once daily