CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 238 enrolled
Drug / intervention
Rengalin +1 moredrug
Likely dose
Rengalin oral administration (specific dose not stated)AI-extracted
Key inclusion· 6
  • ✓Age 40-80 years
  • ✓COPD diagnosed ≥12 months before inclusion per GOLD-2014 guidelines
  • ✓Stable COPD course with ≥6 weeks free of disease progression
  • ✓FEV1/FVC <0.7 and post-bronchodilator FEV1 ≥30% of predicted (mild, moderate, or severe obstruction)
Key exclusion· 11
  • ✕Prior diagnosis of non-COPD causes of cough (asthma, lung cancer, tuberculosis, sarcoidosis, α1-antitrypsin deficiency, bronchiectasis, cystic fibrosis, interstitial pulmonary disease, allergic rhinitis, GERD, ACE inhibitor use, upper respiratory tract disease)
  • ✕COPD exacerbation or acute respiratory infection within 4 weeks before inclusion
  • ✕Very severe bronchial obstruction: post-bronchodilator FEV1 <30% predicted or <50% with chronic respiratory failure
  • ✕Stroke within 3 months or with residual deficit within 6 months before study entry

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03159091
NCT03159091Phase 4Completed
CompareCT.gov

Multicenter Double-blind Placebo-controlled Parallel-group Randomized Clinical Trial of Efficacy and Safety of Rengalin in the Treatment of Cough in Patients With Chronic Obstructive Pulmonary Disease

Materia Medica Holding·interventional·Posted May 18, 2017·Updated Dec 11, 2020

In Brief

A Phase 4 clinical trial evaluating Rengalin and Placebo for Chronic Obstructive Pulmonary Disease. Completed, enrolled 238 participants across 18 sites.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Obstructive Pulmonary Disease
CountriesRussia
Collaborators--

Timeline

Phase 4CompletedFinished
201820192020202120222023202420252026
First PostedMay 18, 2017
Enrollment StartJun 16, 2017
Primary CompletionApr 25, 2019
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 9.1 years ago

Interventions

Rengalindrug

Oral administration.

Placebodrug

Oral administration.