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

NCT03388853 | Completed Phase 4

• 1 other identifier: NEU-06.15
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 2

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.

Conditions

COPD

Keywords

Acetylcysteine/Doxofylline; Acetylcysteine; Doxofylline; Effervescent Tablet; COPD

Outcome Measures

Primary Outcomes (1)

• Mean changes in Breathlessness, Cough, and Sputum Scale (BCSS) score from baseline

  4 weeks

Secondary Outcomes (6)

• 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

Study Arms (2)

Acetylcysteine/Doxofylline

EXPERIMENTAL

Acetylcysteine/Doxofylline 1200/400 mg Effervescent Tablet once daily for four weeks.

Drug: Acetylcysteine/Doxofylline

Placebo

PLACEBO COMPARATOR

Placebo once daily for four weeks

Other: Placebo

Interventions

Acetylcysteine/Doxofylline DRUG

Acetylcysteine/Doxofylline 1200/400 mg Effervescent Tablet once daily for four weeks.

Also known as: Mucofix 1200/400 mg Effervescent Tablet

Acetylcysteine/Doxofylline

Placebo OTHER

Placebo once daily for four weeks.

Placebo

Eligibility Criteria

• Age: 40 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Neutec Ar-Ge San ve Tic A.Ş: lead

Study Sites (2)

Cukurova University Faculty of Medicine, Chest Diseases Department

Adana, Turkey (Türkiye)

Location

Health Sciences University, Sureyyapasa Chest Diseases and Thoracic Surgery Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Acetylcysteine; doxofylline

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2017
• First Posted: January 3, 2018
• Study Start: February 20, 2018
• Primary Completion: December 21, 2019
• Study Completion: December 21, 2019
• Last Updated: June 12, 2020

Record last verified: 2017-12

Locations

TU (2)