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

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.

Study Overview

• Status: Completed
• Conditions: COPD
• Intervention / Treatment: Drug: Acetylcysteine/Doxofylline; Other: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Phase 4

Contacts and Locations

Study Locations

• Turkey
  • Adana, Turkey
    • Cukurova University Faculty of Medicine, Chest Diseases Department
  • Istanbul, Turkey
    • Health Sciences University, Sureyyapasa Chest Diseases and Thoracic Surgery Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 36 years to 96 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acetylcysteine/Doxofylline; Acetylcysteine/Doxofylline 1200/400 mg Effervescent Tablet once daily for four weeks.	Drug: Acetylcysteine/Doxofylline; Acetylcysteine/Doxofylline 1200/400 mg Effervescent Tablet once daily for four weeks.; Other Names: Mucofix 1200/400 mg Effervescent Tablet
Placebo Comparator: Placebo; Placebo once daily for four weeks	Other: Placebo; Placebo once daily for four weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Neutec Ar-Ge San ve Tic A.Ş

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2018
• Primary Completion (Actual): December 21, 2019
• Study Completion (Actual): December 21, 2019

Study Registration Dates

• First Submitted: December 12, 2017
• First Submitted That Met QC Criteria: December 25, 2017
• First Posted (Actual): January 3, 2018

Study Record Updates

• Last Update Posted (Actual): June 12, 2020
• Last Update Submitted That Met QC Criteria: June 11, 2020
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: COPD; Acetylcysteine; Acetylcysteine/Doxofylline; Doxofylline; Effervescent Tablet
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Autonomic Agents; Peripheral Nervous System Agents; Antiviral Agents; Enzyme Inhibitors; Protective Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Antioxidants; Antidotes; Phosphodiesterase Inhibitors; Free Radical Scavengers; Antitussive Agents; Expectorants; Acetylcysteine; N-monoacetylcystine; Doxofylline
• Other Study ID Numbers: NEU-06.15

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No