Status:
COMPLETED
Efficacy and Safety Study of Acetylcysteine/Doxofylline 1200/400 mg Effervescent Tablet in the Treatment of Moderate-Severe COPD.
Lead Sponsor:
Neutec Ar-Ge San ve Tic A.Ş
Conditions:
COPD
Eligibility:
All Genders
40-100 years
Phase:
PHASE4
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 20 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 21 2019
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT03388853
Start Date
February 20 2018
End Date
December 21 2019
Last Update
June 12 2020
Active Locations (2)
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1
Cukurova University Faculty of Medicine, Chest Diseases Department
Adana, Turkey (Türkiye)
2
Health Sciences University, Sureyyapasa Chest Diseases and Thoracic Surgery Training and Research Hospital
Istanbul, Turkey (Türkiye)