Efficacy and Safety Study of Acetylcysteine/Doxofylline 1200/400 mg Effervescent Tablet in the Treatment of Moderate-Severe COPD.
- Conditions
- COPD
- Interventions
- Drug: Acetylcysteine/DoxofyllineOther: Placebo
- Registration Number
- NCT03388853
- Lead Sponsor
- Neutec Ar-Ge San ve Tic A.Ş
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 68
- Patients aged ≥40 years with moderate-severe COPD diagnosis according to the GOLD and on a therapeutic regimen for COPD for a year
- Patients with post-bronchodilator FEV1/FVC ratio <0.70
- Patients with post-bronchodilator FEV1≥30% and <80% of predicted normal value.
- Current smokers or ex-smokers with a smoking history of at least 10 pack-years
- Patients who have no exacerbation within last 4 weeks
- Females patients with childbearing potential using effective birth control method
- Patients who have a capability of communicate with investigator
- Patients who accept to comply with the requirements of the protocol
- Patients who signed written informed consent prior to participation
- History of hypersensitivity to drugs contain Acetylcysteine or Doxofylline or other mucolitics or xanthines
- Patients who use mucolitic and/or xantines derivatives or ephedrine routinely.
- Patients who use CPAP (continous positive airway measure), BiPAP (bilevel continous positive airway measure) or mechanical ventilation
- History of chronic respiratory diseases except COPD.
- Patients who had COPD exacerbation or lower respiratory track infections that required antibiotic, oral or parenteral corticosteroid treatment within 4 weeks prior to first visit.
- Patients who have a history of myocardial infarction, hearth failure, acute ischemic coroner disease or severe cardiac arrhythmia requiring treatment within least 6 weeks.
- History of significant or uncontrolled disease or operation that may preclude participant from participating in the study
- Patients who have lung cancer
- Patients who had lung volume reduction operation
- Women patients who are pregnant or nursing
- History of allergic rhinitis or atopy
- Patients who have known serious prostatic hypertrophy or narrow-angle glaucoma requiring drug therapy
- History of alcohol abuse.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Acetylcysteine/Doxofylline Acetylcysteine/Doxofylline Acetylcysteine/Doxofylline 1200/400 mg Effervescent Tablet once daily for four weeks. Placebo Placebo Placebo once daily for four weeks
- Primary Outcome Measures
Name Time Method Mean changes in Breathlessness, Cough, and Sputum Scale (BCSS) score from baseline 4 weeks
- Secondary Outcome Measures
Name Time Method Mean changes in Clinical COPD Questionnaire (CCQ) score from baseline 4 weeks Mean changes in Modified Medical Research Council dyspnea scale (mMRC) from baseline 4 weeks Mean changes in FEV1 from baseline 4 weeks Mean changes in FVC from baseline 4 weeks Mean changes in serum C-reactive protein (CRP) concentration from baseline 4 weeks Evaluation of safety of study drug 4 weeks Number of participants with treatment-related adverse events and/or abnormal laboratory values.
Trial Locations
- Locations (2)
Cukurova University Faculty of Medicine, Chest Diseases Department
🇹🇷Adana, Turkey
Health Sciences University, Sureyyapasa Chest Diseases and Thoracic Surgery Training and Research Hospital
🇹🇷Istanbul, Turkey