Advertisement

Topics

Long-Term Safety Performance of Fexofenadine in Asthma

2014-08-27 03:55:47 | BioPortfolio

Summary

The purpose of this study is to assess the long-term safety performance of fexofenadine compared to montelukast in subjects with asthma

Description

The incidence of respiratory allergy in the US has increased gradually over the past several years, and current estimates suggest that allergic rhinitis and bronchial asthma affect approximately 20% and 5% of the population, respectively. Rhinitis and asthma frequently coexist, and large-scale population surveys indicate that up to 38% of subjects with rhinitis have asthma, and up to 78% of subjects with asthma have chronic nasal symptoms. Safety concerns with the increased use of inhaled corticosteroids, the heterogeneity of the disease, and poor compliance with asthma medication regimens, point to the need for the development of safe and convenient oral therapies for asthma. Oral leukotriene receptor antagonists (eg montelukast) are the latest class of inflammation-modulating asthma drugs and appear to cause fewer long-term side effects than systemic corticosteroids and reduce the need for shorter-acting bronchodilator reliever medicines. However variability in response between patients has been observed and clinical experience with these agents is still limited.

Histamine is an important chemical mediator of inflammation in asthma. The benefits of antihistamine treatment in patients with mild to moderate asthma have been well documented, however their clinical use has been previously limited due to the high doses required for efficacy and their associated side effects including sedation and cognitive impairment. Recent evidence indicates that in addition to H1-receptor antagonism, some of the newer nonsedating, non-impairing antihistamines appear to possess various anti-inflammatory properties at concentrations achieved at therapeutic dosages suggesting an additional benefit of these drugs in the management of allergic diseases and asthma. The purpose of this study is to assess the long-term safety performance of fexofenadine compared to montelukast in subjects with asthma.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Asthma

Intervention

Fexofenadine, Comparator = Montelukast

Location

Aventis Pharmaceutical Inc.
Bridgewater
New Jersey
United States
08807

Status

Completed

Source

Sanofi-Aventis

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:55:47-0400

Clinical Trials [1616 Associated Clinical Trials listed on BioPortfolio]

Montelukast Back to School Asthma Study

This study, in children with chronic asthma, evaluates the number of days of worsening asthma during 8 weeks of treatment with montelukast after treatment is started for the first day of s...

Montelukast Asthmatic Smoker Study

This is a multicenter study to evaluate the efficacy and safety of MK0476 versus placebo in patients with chronic asthma who actively smoke cigarettes.

Montelukast Compared With Placebo and Salmeterol in Exercise-Induced Bronchoconstriction

To determine the effect of an approved medication being studied in support of a new approach in the prevention of exercise-induced asthma (a worsening of asthma caused by exercise, also kn...

MK0524 Asthma POC Study

The purpose of the study is to demonstrate the benefit of MK0524 compared to placebo in patients with chronic asthma.

Study to Evaluate the Inflammatory Cells Activity in Patients With Persistent Asthma Treated With Montelukast (0476-403)(COMPLETED)

Verify if the quantitative parameters of the eosinophils activation and phagocyte system function show a predictive value for clinical response and prognostic in patients with persistent a...

PubMed Articles [1047 Associated PubMed Articles listed on BioPortfolio]

Montelukast inhibits hypoxia inducible factor-1α translation in prostate cancer cells.

Through regulating the expression of hundreds of genes, hypoxia-inducible factor -1(HIF-1) plays a critical role in hypoxic adaption of cancer cells and is considered as a target for cancer therapy. H...

The cysteinyl leukotriene receptor 1 (CysLT1R) antagonist montelukast suppresses matrix metalloproteinase-13 expression induced by lipopolysaccharide.

Bacterial products such as LPS are critical factors responsible for bone destruction. MMP-13, a member of the matrix metalloproteinase family, plays a critical role in the proteolytic degradation of e...

Early Discontinuation of Montelukast Treatment; A Danish Nationwide Utilization Study.

Montelukast, a leukotriene receptor antagonist, was marketed in 1998 as an oral supplementary treatment to patients with mild to moderate asthma. The aim of this study was to describe the early discon...

Seasonality of sputum eosinophilia in adolescents with asthma remission - effects of montelukast.

Remission of asthma may occur at any age, but most commonly presents during adolescence and young adulthood. Eosinophilic inflammation is the predominant type of inflammation in asthmatic children and...

Montelukast inhibits inflammatory response in rheumatoid arthritis fibroblast-like synoviocytes.

Montelukast, a potent selective antagonist of cysteinyl leukotriene (cysLT) receptors, has displayed its important anti-oxidative and anti-inflammatory effects in various tissues and organs. Rheumatoi...

Medical and Biotech [MESH] Definitions

Asthma attacks caused, triggered, or exacerbated by OCCUPATIONAL EXPOSURE.

Asthma attacks following a period of exercise. Usually the induced attack is short-lived and regresses spontaneously. The magnitude of postexertional airway obstruction is strongly influenced by the environment in which exercise is performed (i.e. inhalation of cold air during physical exertion markedly augments the severity of the airway obstruction; conversely, warm humid air blunts or abolishes it).

Drugs that are used to treat asthma.

A beta-adrenergic agonist used in the treatment of asthma and bronchospasms.

A beta-2 adrenergic agonist used in the treatment of ASTHMA and BRONCHIAL SPASM.

More From BioPortfolio on "Long-Term Safety Performance of Fexofenadine in Asthma"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Asthma
Asthma is caused by inflammation of small tubes, called bronchi, which carry air in and out of the lungs. If you have asthma, the bronchi will be inflamed and more sensitive than normal.  When you come into contact with something that irritates your...

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 ...

Allergies
The term allergy is used to describe a response, within the body, to a substance, which is not necessarily harmful in itself, but results in an immune response and a reaction that causes symptoms and disease in a predisposed person, which in turn can cau...


Searches Linking to this Trial