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

• Status: Completed
• Trial end date: 2019-12-21
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Neutec Ar-Ge San ve Tic A.Ş
• Treatments: Acetylcysteine; Doxofylline; N-monoacetylcystine

Criteria

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.