Clinical Trial of Efficacy and Safety of Rengalin in the Treatment of Cough in Patients With Chronic Obstructive Pulmonary Disease
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Rengalin; Placebo
Intervention description: Oral administration.; Oral administration.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 238.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to obtain additional data on efficacy and safety of Rengalin in
      the treatment of cough in patients with stable obstructive pulmonary disease
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients of both sexes aged from 40 to 80 years old.

          2. COPD diagnosed (in accordance with the GOLD-2014 guidelines) ≥12 months before
             inclusion.

          3. Stable course of COPD (≥ 6 weeks free of disease progression).

          4. Mild, moderate or severe degree of bronchial obstruction (FEV1/FVC < 0.7;
             post-bronchodilator FEV1 ≥30% of predicted value).

          5. CSS score ≥2.

          6. Stable dose of standard therapy within the preceding 4 weeks.

          7. Use of and adherence to contraceptive methods by fertile-age patients of both sexes
             during the study.

          8. Availability of a signed patient information sheet (Informed Consent form) for
             participation in the trial.

        Exclusion Criteria:

          1. Earlier diagnosis of intra- or extrathoracic causes of cough (e.g., asthma, malignant
             neoplasm of lung, tuberculosis, sarcoidosis, α1-antitrypsin deficiency,
             bronchiectasis, cystic fibrosis, interstitial pulmonary diseases, perennial allergic
             rhinitis, gastro-oesophageal reflux disease, use of ACE inhibitors, disease of upper
             respiratory tract, etc.).

          2. Cough associated with eating.

          3. An exacerbation of COPD, acute upper and/or lower respiratory infection at inclusion
             or in the previous 4 weeks.

          4. Modifications to standard drug therapy (dose escalation, replacement of medicines
             prescribed or addition of new medications) in the previous 4 weeks.

          5. Very severe degree of bronchial obstruction (post-bronchodilator FEV1 <30% pred or <
             50% and chronic respiratory failure).

          6. Haemoptysis.

          7. Stroke in the preceding 3 months or stroke with long-term residual neurological
             deficit within 6 months before study entry.

          8. Acute coronary syndrome, myocardial infarction within 6 months before study
             enrollment.

          9. Unstable or life-threatening arrhythmia in the previous 3 months.

         10. Acute or chronic heart failure (NYHA (1964) Class III or IV).

         11. Presence or suspicion of oncological disease.

         12. Body Mass Index (BMI) ≤18 kg/m2 or ≥40 kg/m2.

         13. Chronic kidney disease (categories С3-5 А3).

         14. Hepatic failure (Child-Pugh class C)

         15. Exacerbation or decompensation of a chronic disease that would affect the patient's
             ability to participate in the clinical trial.

         16. For smokers - intention to quit smoking in the next 4 weeks.

         17. Allergy/intolerance to any of the components of medications used in the treatment.

         18. Course intake of medicines listed in the section 'Prohibited concomitant treatment'
             for 4 weeks prior to the enrollment in the trial.

         19. Participation in other clinical trials within 3 months prior to the enrollment in this
             study.

         20. Patients who, from investigator's point of view, will fail to comply with the
             observation requirements of the trial or with the dosing regimen of the
             investigational drug.

         21. Other conditions preventing the patient from normal participation (e.g., planned
             business or other trips).

         22. Drug addiction, alcohol use in the amount over 2 units of alcohol a day, mental
             diseases.

         23. Pregnancy, breast-feeding, unwillingness to use contraception during the study.

         24. Patient is related to the research staff of the clinical investigative site who are
             directly involved in the trial or is the immediate family member of the investigator.
             The immediate family members include husband/wife, parents, children or brothers (or
             sisters), regardless of whether they are natural or adopted.

         25. Patient works for MATERIA MEDICA HOLDING company (i.e., is the company's employee,
             temporary contract worker or appointed official responsible for carrying out the
             research or their immediate family).