The objective is to assess efficacy and safety of Acetylcysteine/Doxofylline 1200/400 mg Effervescent Tablet once daily treatment besides standard/usual treatment, as compared with placebo once daily in patients with stable moderate to severe COPD.
The objective is to assess efficacy and safety of Acetylcysteine/Doxofylline 1200/400 mg Effervescent Tablet once daily treatment besides standard/usual treatment, as compared with placebo once daily in patients with stable moderate to severe COPD. Patients who met all inclusion criteria will be randomized to receive double-blind treatment with Acetylcysteine/Doxofylline 1200/400 mg Effervescent Tablet once daily (n = 35) or placebo (n = 35) once daily for 4 weeks. Patients will be evaluated at 2 consecutive visits: screening \& treatment visit (first visit) and after treatment visit (second visit). Spirometric measurements will be performed at pre-treatment during the first visit and post-treatment at two different time points (23 hr + 15 min and 23 hr + 45 min) during the second visit. The average of the values at 23 hr 15 min and 23 hr 45 min during the second visit will be defined as trough value.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
68
Acetylcysteine/Doxofylline 1200/400 mg Effervescent Tablet once daily for four weeks.
Placebo once daily for four weeks.
Cukurova University Faculty of Medicine, Chest Diseases Department
Adana, Turkey (Türkiye)
Health Sciences University, Sureyyapasa Chest Diseases and Thoracic Surgery Training and Research Hospital
Istanbul, Turkey (Türkiye)
Mean changes in Breathlessness, Cough, and Sputum Scale (BCSS) score from baseline
Time frame: 4 weeks
Mean changes in Clinical COPD Questionnaire (CCQ) score from baseline
Time frame: 4 weeks
Mean changes in Modified Medical Research Council dyspnea scale (mMRC) from baseline
Time frame: 4 weeks
Mean changes in FEV1 from baseline
Time frame: 4 weeks
Mean changes in FVC from baseline
Time frame: 4 weeks
Mean changes in serum C-reactive protein (CRP) concentration from baseline
Time frame: 4 weeks
Evaluation of safety of study drug
Number of participants with treatment-related adverse events and/or abnormal laboratory values.
Time frame: 4 weeks
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