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
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".
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
238
Regional state budgetary health care institution "Regional Clinical Hospital"
Barnaul, Russia
Percentage of Patients With a Positive Treatment Response
Cough Severity Scale (CSS) total score. Cough intensity according to the scale is assessed in daytime and at night in points where 0 - no cough, 5 - continuous exhausting cough in daytime and at night. Response criterion: ≥1 lower total CSS score compared to baseline.
Time frame: in 4 weeks of the treatment
Severity of Cough After 4 Weeks Compared to Baseline
Cough Severity Scale (CSS) total score. Cough intensity according to the scale is assessed in the daytime and at night in points, where 0 - no cough, 5 - continuous exhausting cough in the daytime, and at night.
Time frame: Baseline and 4 weeks after the treatment
Percentage of Patients With ≥50% Lesser Cough Severity at 4 Weeks
Number of Participants with a Decrease from Baseline of ≥50% in Cough Severity at 4 weeks. Based on the total Cough Severity Scale (CSS) score. Cough intensity according to the scale is assessed in the daytime and at night in points, where 0 - no cough, 5 - continuous exhausting cough in the daytime and at night.
Time frame: in 4 weeks of the treatment
Changes in Clinical Symptoms of Chronic Obstructive Pulmonary Disease (COPD)
Based on the total COPD Assessment Test (CAT) score. CAT consists of 8 items. Each item ranges from "0" to "5" balls. The total score ranges from minimum "0" to maximum "40" points. Higher values represent a worse outcome.
Time frame: in 4 weeks of the treatment
Percentage of Patients With no Exacerbation of COPD
COPD exacerbation is defined as an acute event characterized by aggravation of the event within 2-3 or more days. Exacerbation manifests in intensification of respiratory disorders beyond their regular daily fluctuations and require administration of products in addition to the previously prescribed basic therapy as well as a rescue drug for symptom relief (salbutamol). Additional products include antibacterial drugs, systemic corticosteroids and/or emergency therapy (ambulance call) or hospitalization for COPD exacerbation. COPD exacerbation is recorded as an adverse event. If a COPD exacerbation develops within the first week of the subject participation in the study, it will not be considered as a secondary inefficacy criterion
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Regional state budget health care institution "City Hospital No. 5, Barnaul"
Barnaul, Russia
NUZ "Road Clinical Hospital at the station Chelyabinsk JSC" RZhD "
Chelyabinsk, Russia
The State Budget Health Institution "Regional Clinical Hospital No. 4"
Chelyabinsk, Russia
Federal State Budgetary Educational Institution of Higher Education "Kazan Medical University"/Central City Clinical Hospital and Clinic #18
Kazan', Russia
Federal State Budgetary Educational Institution of Higher Education "Kazan Medical University"/Professor's Clinic
Kazan', Russia
Pirogov Russian National Research Medical University
Moscow, Russia
State Budgetary Institution of Health Care of the Nizhny Novgorod Region "City Clinical Hospital No. 10"
Nizhny Novgorod, Russia
Ryazan State Medical University named after academician I.P. Pavlov
Ryazan, Russia
North-Western State Medical University named after I.I. Mechnikov
Saint Petersburg, Russia
...and 8 more locations
Time frame: in 4 weeks of the treatment