COPD Clinical Trial
Official title:
Efficacy and Safety Study of Acetylcysteine/Doxofylline 1200/400 mg Effervescent Tablet in the Treatment of Moderate-Severe Chronic Obstructive Pulmonary Disease (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.
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.
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