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
Study type: Interventional
Phase: Phase 4

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
    

Detailed description: 
      Design: multicenter, double-blind, randomized, parallel group placebo-controlled study.

      The study will enroll men and women (aged 40 to 80 years) with cough associated with stable
      chronic obstructive pulmonary disease (COPD). Subjects with COPD diagnosed more than 12
      months earlier obtaining allowed basic therapy and retaining cough ≥2 points (according to
      cough severity scale [CSS]) despite their therapy should be considered as the study
      candidates.

      After signing patient information leaflet (informed consent form) to participate in the
      clinical study, collection of medical history and objective examination are performed, cough
      severity is assessed (using CSS; at baseline evaluation of diurnal and nocturnal cough the
      number of episodes and cough severity in the preceding day is taken into account) as well as
      intensity of COPD effect on the subject (САТ test), concomitant therapy is recorded, computer
      spirometry with evaluation of baseline FEV1/FVC and post-bronchodilator FEV1 (where
      respiratory function cannot be assessed, the results of the previous examination dating no
      more than 3 months earlier may be used). Females of childbearing potential will undergo
      pregnancy test.

      If a patient meets the inclusion criteria and does not demonstrate any of the exclusion
      criteria at Visit 1 (Day 1), he/she is randomized to one of 2 groups: group 1 patients will
      receive Rengalin at 2 tablets 3 times a day for 4 weeks; group 2 patients will receive
      placebo using Rengalin dosing regimen for 4 weeks.

      The patient will be monitored for 4 weeks (screening, randomization - before day 1, treatment
      - 4 weeks). During follow-up period two visits are scheduled (Visit 1 (Day 1) and Visit 2
      (Week 4) at which objective examination, recording cough severity (using CSS) will be carried
      out, COPD effect on the subjects (САТ test) and concomitant therapy will be evaluated. At
      Visit 2 (after 4-week treatment period) compliance will be additionally assessed.

      At one of the clinical sites (Research Institute of Pulmonology, Russian FMBA), patients will
      be monitored for cough on a daily basis (using the WHolter™ monitor), with the data used as
      an additional measure to evaluate efficacy.

      Subjects are allowed to take basic COPD therapy and medications for their co-morbidities in
      the course of the study, except for the medicines listed in "Prohibited concomitant
      treatment".
    

Intervention name(s): Rengalin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral administration.; Oral administration.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment