administrative decision

The purpose of this study is to compare acute bronchodilator effects of Ipratropium/Levosalbutamol 20/50 mcg Fixed Dose Combination (2 inhalations) via pMDI and Salbutamol 100 mcg Inhaler (2 inhalations) plus Ipratropium 20 mcg Inhalation Aerosol (2 inhalations) Free Combination in Patients with stable moderate-severe-very severe COPD.

Inclusion Criteria:

• Female and male patients aged ≥40 years diagnosed with symptomathic stable moderate-severe-very severe COPD: post-bronchodilator FEV1/FVC <70% predicted and a post-bronchodilator FEV1 <80% predicted at screen visit.

Group B COPD CAT: ≥10 or mMRC: ≥ 2 Exacerbation: 0-1 (not leading to hospital admission)

Group C COPD CAT: <10 or mMRC: 0-1 Exacerbation: ≥2 (not leading to hospital admission) or ≥1 (leading to hospital admission)

Group D COPD CAT: ≥10 or mMRC: ≥ 2 Exacerbation: ≥2 (not leading to hospital admission) or ≥1 (leading to hospital admission)

• Current or ex-smokers with a smoking history of at least 10 pack-years
• Patients who have no exacerbation within the last 4 weeks
• Female patients who use effective contraception
• Patients who have a capability to communicate with investigator
• Patients who accept to comply with the protocol
• Patients who sign written informed consent form

Exclusion Criteria:

• History of hypersensitive to anticholinergics or SABAs
• History of COPD exacerbation or lower respiratory track infection that required treatment with antibiotic, oral or parenteral corticosteroid within the last 4 weeks prior the screening visit or during the run-in/wash-out period or history of respiratory tract infection that required treatment with antibiotic within the last 14 days prior the screening visit.
• Hospitalization due to COPD or pneumonia within the last 3 mounts prior the screening visit
• Use of oral corticosteroid at unstable dosages (i.e. <6 weeks on a stable dose of prednisone)
• SGOT (serum glutamic oxaloacetic transaminase) >80 IU/L, SGPT (serum glutamic pyruvic transaminase) >80 IU/L, bilirubin >2.0 mg/dL or creatinine >2.0 mg/dL
• History of asthma, significant chronic respiratory diseases (i.e., significant bronchiectasis, interstitial lung diseases, etc.) other than COPD or presence of disease that may be serious and/or potentially affect results of the study.
• Initiation of an inhaled steroid or change in dose within <6 weeks prior the screening visit
• Use of beta-blocker, monoamine oxidase (MAO) inhibitor or tricyclic antidepressant within the last 30 days prior the screening visit
• Recent (within ≤1 year prior the screening visit) history of heart attack, heart failure, acute ischemic heart disease or presence of serious cardiac arrhythmia requiring drug treatment
• Regularly use of daytime CPAP (continuous positive airway measure) oxygen therapy for longer than 1 hour per day
• Initiation of pulmonary rehabilitation within the 3 months prior the screening visit
• History of lung volume reduction surgery
• Drug or alcohol abuse
• Presence of active tuberculosis
• History of atopy or allergic rhinitis
• History of cancer within the last 5 years
• Attenuated live virus vaccination within the last 2 weeks prior the screening visit or during the run-in/wash-out period
• Pregnancy or lactation
• Presence of known symptomatic prostatic hypertrophy requiring treatment
• Presence of known narrow-angle glaucoma requiring treatment
• Currently participating in another clinical trial or treatment with another investigational study drug within the last month or 6-half-lives, whichever is longer.