Topics

Clinical Trial of Efficacy and Safety of Levopront® 30 mg/5 ml in Patients With Dry Cough

2019-02-17 22:19:15 | BioPortfolio

Summary

Primary objective:

To assess the efficacy of Levopront® in comparison with Libexin® based on daytime cough resolution rate by Day 8.

The daytime cough symptoms resolution corresponds to 0 or 1 points on the "Six-point daytime and nighttime cough assessment scale".

Secondary objectives:

Treatment effect assessment in terms of the following efficacy and safety parameters:

- To assess the efficacy of Levopront® in comparison with Libexin® based on nighttime cough resolution rate by Day 8.

- Daytime and nighttime cough symptoms resolution according to "Six-point daytime and nighttime cough assessment scale" by Day 4.

- Change in severity and frequency of daytime and nighttime cough according to "Six-point daytime and nighttime cough assessment scale" on Day 4 and Day 8 from baseline on Day 1.

- Cough intensity change according to the visual-analogue scale on Day 4 and Day 8 from baseline on Day 1.

- Change of FEV1 on Day 8 from baseline values on Day 1.

- Rate of Adverse events (AE) and Serious Adverse Events (SAE) of the various severity according to subjective complaints, laboratory test results, physical examination, vital signs and spirometry

Description

This is a multicenter, open-label, randomized, clinical trial to assess the efficacy and safety of Levopront® syrup 30 mg/5 ml in comparison with Libexin® 100 mg tablets in patients suffering from dry non-productive cough caused by acute upper respiratory infection

Study Design

Conditions

Cough

Intervention

Levopront® syrup 30 mg/5 ml, Libexin®

Location

State Public Healthcare Institution of Moscow "City Clinical Hospital # 71 of Moscow Healthcare Department"
Moscow
Russian Federation
121374

Status

Completed

Source

Dompé Farmaceutici S.p.A

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-02-17T22:19:15-0500

Clinical Trials [256 Associated Clinical Trials listed on BioPortfolio]

Comparison of a Protective Cough Syrup Against Placebo on Night Cough in Children 1-5 Years Coughing Since 1- 2 Days Due to Common Cold

The intent of this study is to see how boys and girls aged 1-5 and coughing since 1-2 days due to common cold respond to a specific protective cough syrup taken before going to bed for one...

Efficacy & Tolerability of a Specific Plantain,Thyme and Honey Cough Syrup vs Placebo in Child Cough Due to Common Cold

Cough is a life saving reflex, therefore it is important, especially in pediatrics, to calm cough spells without sedating the reflex. The intent of this study is to use a protective syrup ...

Phase III Study to Evaluate the Efficacy and Safety of HOB-048 CR Tab. in Comparison With HOB-048 Syrup in Patients With Cough Due to Acute or Chronic Bronchitis

A randomized, double-blind, multicenter, active-controlled phase III study to evaluate the efficacy and safety of Levotuss CR tab. in comparison with Levotuss syrup in patients with cough ...

Efficacy, Safety and Palatability of the Syrup "KalobaTuss® Children" for the Treatment of Cough in Children

Cough of children is one of the most frequent events for which parents ask for a medical consult and it is a true challenge for pediatrics during daily practice. In the majority of cases,...

Comparative Efficacy of the Suppository Composed by Guaiacol, Eucalyptol, Menthol and Camphor Versus Guaiacol Suppository Versus Guaifenesin Syrup in Pediatric Patients With Cough Due the Infectious Origin

It is believed that the suppository consisting of guaiacol, menthol, camphor and eucalyptol, by their pharmacological properties already established for each component, has the ability to ...

PubMed Articles [196 Associated PubMed Articles listed on BioPortfolio]

What is Chronic Cough? Terminology.

Terminology used to define clinical cough is based on features such as duration, underlying causes and associated characteristics such as whether the cough is 'dry' or 'productive'. Terms such as 'Ref...

Subfreezing air as a cough trigger and multiple triggers are strongly associated with the presence of asthma in chronic cough.

Management of chronic cough relies on the recognition of cough background disorders. It is not known whether certain cough triggers are associated with specific background disorders.

Induction of airway remodeling and persistent cough by repeated citric acid exposure in a guinea pig cough model.

A previous study involving guinea pigs showed that repeated cough could increase peripheral airway smooth muscle area, which can also aggravate cough. The airway pathologic changes produced by prolong...

Quantifying test-retest variability of natural and suppressed citric acid cough thresholds and urge to cough ratings.

The citric acid cough reflex test (CRT) is used to quantify cough sensitivity and evaluate the effects of cough therapies and antitussive medications. This study quantifies the test-retest variability...

Contemplating Chronic Cough in Children.

Chronic cough is one of the most common reasons children seek care from their pediatrician. A cough can be distressing both to the patient and family as it may raise concerns for a significant underly...

Medical and Biotech [MESH] Definitions

Syrup made from corn used widely in foods and beverages as a cheaper alternative sweetener to SUCROSE (common table sugar). It is generated by enzymatic processing of natural corn syrup to produce a liquid most widely composed of 42 or 55% FRUCTOSE, GLUCOSE, and various POLYSACCHARIDES.

Agents that suppress cough. They act centrally on the medullary cough center. EXPECTORANTS, also used in the treatment of cough, act locally.

A syrup made from the dried rhizomes of two different species, CEPHAELIS ipecacuanha and C. acuminata. They contain EMETINE, cephaeline, psychotrine and other ISOQUINOLINES. Ipecac syrup is used widely as an emetic acting both locally on the gastric mucosa and centrally on the chemoreceptor trigger zone.

A synthetic opioid that is used as the hydrochloride. It is an opioid analgesic that is primarily a mu-opioid agonist. It has actions and uses similar to those of MORPHINE. It also has a depressant action on the cough center and may be given to control intractable cough associated with terminal lung cancer. Methadone is also used as part of the treatment of dependence on opioid drugs, although prolonged use of methadone itself may result in dependence. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1082-3)

An autosomal recessive inherited disorder with multiple forms of phenotypic expression, caused by a defect in the oxidative decarboxylation of branched-chain amino acids (AMINO ACIDS, BRANCHED-CHAIN). These metabolites accumulate in body fluids and render a "maple syrup" odor. The disease is divided into classic, intermediate, intermittent, and thiamine responsive subtypes. The classic form presents in the first week of life with ketoacidosis, hypoglycemia, emesis, neonatal seizures, and hypertonia. The intermediate and intermittent forms present in childhood or later with acute episodes of ataxia and vomiting. (From Adams et al., Principles of Neurology, 6th ed, p936)

More From BioPortfolio on "Clinical Trial of Efficacy and Safety of Levopront® 30 mg/5 ml in Patients With Dry Cough"

Quick Search

Relevant Topics

Drug Discovery
Clinical Approvals Clinical Trials Drug Approvals Drug Delivery Drug Discovery Generics Drugs Prescription Drugs In the fields of medicine, biotechnology and pharmacology, drug discovery is the process by which drugs are dis...

Respiratory
Asthma COPD Cystic Fibrosis Pneumonia Pulmonary Medicine Respiratory Respiratory tract infections (RTIs) are any infection of the sinuses, throat, airways or lungs.  They're usually caused by viruses, but they can also ...

Infectious-diseases
Antiretroviral Therapy Clostridium Difficile Ebola HIV & AIDS Infectious Diseases Influenza Malaria Measles Sepsis Swine Flu Tropical Medicine Tuberculosis Infectious diseases are caused by pathogenic...


Searches Linking to this Trial