Clinical Trial of Efficacy and Safety of Rengalin in the Treatment of Cough in Patients With Chronic Obstructive Pulmonary Disease

NCT03159091 | Completed Phase 4 Results

• 1 other identifier: MMH-RN-005
• Study Type: interventional
• Target: 238
• Locations: 1 country
• Sites: 18

Brief 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

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• 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.

  in 4 weeks of the treatment

Secondary Outcomes (4)

• Severity of Cough After 4 Weeks Compared to Baseline

  Baseline and 4 weeks after the treatment

• Percentage of Patients With ≥50% Lesser Cough Severity at 4 Weeks

  in 4 weeks of the treatment

• Changes in Clinical Symptoms of Chronic Obstructive Pulmonary Disease (COPD)

  in 4 weeks of the treatment

• Percentage of Patients With no Exacerbation of COPD

  in 4 weeks of the treatment

Study Arms (2)

Rengalin

EXPERIMENTAL

Oral administration. Two tablets per intake. The tablet should be held in the mouth until complete dissolution. 2 tablets 3 times a day without food (i.e. 15-30 min prior to meal or 15-30 min after meal).

Drug: Rengalin

Placebo

PLACEBO COMPARATOR

Oral administration. Two tablets per intake. The tablet should be held in the mouth until complete dissolution. 2 tablets 3 times a day without food (i.e. 15-30 min prior to meal or 15-30 min after meal).

Drug: Placebo

Interventions

Rengalin DRUG

Oral administration.

Rengalin

Placebo DRUG

Oral administration.

Placebo

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients of both sexes aged from 40 to 80 years old.
• Stable course of COPD (≥ 6 weeks free of disease progression).
• Mild, moderate or severe degree of bronchial obstruction (FEV1/FVC \< 0.7; post-bronchodilator FEV1 ≥30% of predicted value).
• CSS score ≥2.
• Stable dose of standard therapy within the preceding 4 weeks.
• Use of and adherence to contraceptive methods by fertile-age patients of both sexes during the study.
• Availability of a signed patient information sheet (Informed Consent form) for participation in the trial.

You may not qualify if:

• 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.).
• Cough associated with eating.
• Modifications to standard drug therapy (dose escalation, replacement of medicines prescribed or addition of new medications) in the previous 4 weeks.
• Very severe degree of bronchial obstruction (post-bronchodilator FEV1 \<30% pred or \< 50% and chronic respiratory failure).
• Haemoptysis.
• Stroke in the preceding 3 months or stroke with long-term residual neurological deficit within 6 months before study entry.
• Acute coronary syndrome, myocardial infarction within 6 months before study enrollment.
• Unstable or life-threatening arrhythmia in the previous 3 months.
• Acute or chronic heart failure (NYHA (1964) Class III or IV).
• Presence or suspicion of oncological disease.
• Body Mass Index (BMI) ≤18 kg/m2 or ≥40 kg/m2.
• Chronic kidney disease (categories С3-5 А3).
• Hepatic failure (Child-Pugh class C)
• Exacerbation or decompensation of a chronic disease that would affect the patient's ability to participate in the clinical trial.
• For smokers - intention to quit smoking in the next 4 weeks.

Sponsors & Collaborators

• Materia Medica Holding: lead

Study Sites (18)

Regional state budgetary health care institution "Regional Clinical Hospital"

Barnaul, 656024, Russia

Location

Regional state budget health care institution "City Hospital No. 5, Barnaul"

Barnaul, 656045, Russia

Location

NUZ "Road Clinical Hospital at the station Chelyabinsk JSC" RZhD "

Chelyabinsk, 454000, Russia

Location

The State Budget Health Institution "Regional Clinical Hospital No. 4"

Chelyabinsk, 454021, Russia

Location

Federal State Budgetary Educational Institution of Higher Education "Kazan Medical University"/Central City Clinical Hospital and Clinic #18

Kazan', 420012, Russia

Location

Federal State Budgetary Educational Institution of Higher Education "Kazan Medical University"/Professor's Clinic

Kazan', 420012, Russia

Location

Pirogov Russian National Research Medical University

Moscow, 117997, Russia

Location

State Budgetary Institution of Health Care of the Nizhny Novgorod Region "City Clinical Hospital No. 10"

Nizhny Novgorod, 603011, Russia

Location

Ryazan State Medical University named after academician I.P. Pavlov

Ryazan, 390026, Russia

Location

North-Western State Medical University named after I.I. Mechnikov

Saint Petersburg, 191015, Russia

Location

North-western State Medical University named after I.I.Mechnikov

Saint Petersburg, 191015, Russia

Location

St. Petersburg State Budgetary Public Health Institution "Vvedensky City Clinical Hospital"

Saint Petersburg, 191180, Russia

Location

The Federal State Institute of Public Health 'The Nikiforov Russian Center of Emergency and Radiation Medicine'

Saint Petersburg, 194044, Russia

Location

The First Pavlov State Medical University of St. Petersburg

Saint Petersburg, 197022, Russia

Location

St. Petersburg State Budgetary Institution of Health "City Polyclinic No. 106"

Saint Petersburg, 198328, Russia

Location

Samara City Hospital №4

Samara, 443056, Russia

Location

St. Petersburg State Budgetary Institution "City Hospital No. 40 in the Kurortny District"

Sestroretsk, 197706, Russia

Location

Voronezh Regional Clinical Hospital №1

Voronezh, 394066, Russia

Location

Related Publications (1)

• Avdeev SN, Vizel AA, Abrosimov VN, Zaicev AA, Ignatova GL, Khamitov RF, Mikhaylusova MP, Shapovalova JS, Pavlysh EF, Trofimov BI, Emelyanov AV, Martynenko TI, Martynenko VA, Kostina NE, Chizhov DA, Chizhova OY, Kuzubova NA, Makova EV, Makarova EV. Management of Cough in Patients with Chronic Obstructive Pulmonary Disease: Results of the Multicenter Randomized Placebo-Controlled Clinical Trial. Int J Chron Obstruct Pulmon Dis. 2021 May 5;16:1243-1253. doi: 10.2147/COPD.S292109. eCollection 2021.

  PMID: 33981141 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Mikhail Putilovskiy, MD, PhD, Clinical and Medical Department Director
• Organization: Materia Medica Holding

PutilovskiyMA@materiamedica.ru

+74952761571

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: May 17, 2017
• First Posted: May 18, 2017
• Study Start: June 16, 2017
• Primary Completion: April 25, 2019
• Study Completion: April 25, 2019
• Last Updated: December 11, 2020
• Results First Posted: December 11, 2020

Record last verified: 2019-08

Locations

RU (18)