Efficacy and Safety Study of Acetylcysteine/Doxofylline 1200/400 mg Effervescent Tablet in the Treatment of Moderate-Severe COPD.

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy and Safety Study of Acetylcysteine/Doxofylline 1200/400 mg Effervescent Tablet in the Treatment of Moderate-Severe Chronic Obstructive Pulmonary Disease (COPD)

Conditions
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COPD

Intervention / Treatment
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* Drug: Acetylcysteine/Doxofylline
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acetylcysteine/Doxofylline<br>Acetylcysteine/Doxofylline 1200/400 mg Effervescent Tablet once daily for four weeks. | Drug: Acetylcysteine/Doxofylline<br>* Acetylcysteine/Doxofylline 1200/400 mg Effervescent Tablet once daily for four weeks.<br>* Other names: Mucofix 1200/400 mg Effervescent Tablet;|
| Placebo Comparator: Placebo<br>Placebo once daily for four weeks | Other: Placebo<br>* Placebo once daily for four weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean changes in Breathlessness, Cough, and Sputum Scale (BCSS) score from baseline |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Number of participants with treatment-related adverse events and/or abnormal laboratory values. | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, Acetylcysteine/Doxofylline, Acetylcysteine, Doxofylline, Effervescent Tablet