A Study to Evaluate the Efficacy and Safety of DW5121 Compared to DW51211 and DW51212

Exclusion Criteria

• •Subjects who meet any of the following conditions will not be eligible to participate in this clinical trial:
• •1\. History of hypersensitivity to any component of the investigational product or to drugs of a similar class.
• •2\. Presence of any of the following medical histories or past surgical/interventional histories:
• •1. Active infections requiring systemic antibiotic therapy
• •2. Severe pulmonary diseases as determined by the investigator (e.g., bronchiectasis, bronchogenic carcinoma, interstitial lung disease, pneumonia, active tuberculosis, cystic fibrosis, chronic obstructive pulmonary disease, asthma, chronic bronchitis, emphysema, etc.) or clinically significant abnormal findings on chest X-ray
• •3. Obstructive sleep apnea syndrome
• •4. Glaucoma or elevated intraocular pressure
• •5. Lower urinary tract obstruction (e.g., benign prostatic hyperplasia) or voiding dysfunction
• •6. Hemorrhagic diathesis or bleeding tendency
• •7. Hepatic dysfunction (ALT or AST \> 3 × upper limit of normal)
• •8. Renal impairment (glomerular filtration rate \< 30 mL/min)
• •\*eGFR (mL/min/1.73m²) = 175 × (serum creatinine)\^(-1.154) × (age)\^(-0.203) × 0.742 (if female)
• •9. Uncontrolled thyroid dysfunction (TSH ≥ 1.5 × ULN)
• •10. Uncontrolled diabetes mellitus (HbA1c \> 9.0%)
• •11. Uncontrolled hypertension (systolic or diastolic blood pressure ≥ 160/100 mmHg)
• •12. Significant cardiovascular diseases as determined by the investigator (e.g., heart failure of NYHA class III/IV, atherosclerosis, pulmonary hypertension, peripheral artery disease) or QTc interval \> 450 msec or other clinically significant ECG abnormalities
• •13. Active peptic ulcer, gastrointestinal bleeding, or pyloroduodenal obstruction
• •14. Central nervous system diseases such as epilepsy
• •15. Subjects with rare hereditary problems of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
• •16. History of malignancy except in the following cases:
• •(1) Disease-free for at least 5 years following completion of cancer treatment
• •(2) Subjects who have completed curative resection of basal cell carcinoma or squamous cell carcinoma of the skin, curative surgery for papillary thyroid carcinoma, or successful treatment of cervical carcinoma in situ at least 3 years prior to screening
• •3\. Subjects expected to require any of the following medications during the clinical trial:
• •1. Antibiotics, antivirals, systemic/inhaled glucocorticosteroids
• •2. ACE inhibitors or ARBs (Note: Subjects on long-term stable doses of ACEIs or ARBs may be included)
• •3. Mucolytics, expectorants, antitussives, herbal medicines with antitussive/expectorant effects
• •4. Leukotriene receptor antagonists, antihistamines, β2 agonists, anticholinergic bronchodilators, CNS stimulants
• •5. Coumarin-type anticoagulants (e.g., warfarin)
• •6. Symptomatic treatments for acute bronchitis, analgesics (Note: Acetaminophen up to 1.5 g/day taken ≥24 hours before efficacy assessments is permitted)
• •7. Sedatives
• •8. Central nervous system depressants
• •9. Phenytoin
• •10. Monoamine oxidase (MAO) inhibitors administered within 2 weeks prior to the investigational product or expected to be used during the trial (e.g., antidepressants, antipsychotics, mood stabilizers, anti-Parkinson drugs)
• •4\. Heavy smokers (≥15 cigarettes/day)
• •For e-cigarettes, 10 puffs are considered equivalent to one conventional cigarette.
• •5\. Pregnant or lactating women, or women who are unwilling to use appropriate contraception\* or who are planning to become pregnant during the study period.
• •Acceptable contraceptive methods include hormonal contraception, intrauterine devices, sterilization of the partner (vasectomy or tubal ligation), or double-barrier methods (e.g., male condom with female diaphragm, sponge, or cervical cap).
• •6\. Participation in another clinical trial and administration of an investigational drug or device within 4 weeks prior to screening
• •7\. Any other condition that, in the investigator's judgment, would make the subject unsuitable for participation in this clinical trial