Topics

Efficacy and Safety of Flutiform K-haler in Patients With Uncontrolled Asthma Following Mid-dose ICS/LABA DPI Therapy

2019-10-16 10:39:13 | BioPortfolio

Summary

The purpose of this study is to evaluate the efficacy of the Asthma improvement of Flutiform K-haler after 12 weeks of treatment in patients with moderate to severe uncontrolled* asthma following mid-dose ICS/LABA DPI therapy.

Description

Asthma is a chronic inflammatory allergic disease of airway involving many cells and various media. Airway inflammation causes various symptoms of airway hypersensitivity, including repeated wheezing, dyspnea, and tightness in the chest. An estimated 300 million people worldwide suffer from asthma, and in South Korea, an estimated asthma prevalence rate for adults is approximately 5% [1]. For more effective management of asthma, Global Initiative for Asthma (GINA) guideline[2] and Korean Asthma Management Guideline for Adults [1] suggests that for patients who cannot have asthma symptoms under control with ICS (Inhaled Corticosteroid) alone, concomitant treatment of ICS/LABA is more effective than dose increase of ICS, and therefore recommends ICS combined with Long-acting β2-agonist (LABA) products. Common ICS/LABA products that are available in the Korea market including dry power inhaler (DPI) and pressured metered dose inhaler (pMDI).

It is known that small airway significantly contributes to total airway resistance, so the inflammation of the small airways could lead to the poor asthma control observed since small airways are not directly reached by inhaler's particles [3,4]. Fluticasone/formoterol (Flutiform®) shows a high fine particle fraction (FPF) of about 40% for both the ICS and the LABA components regardless the inhalation flow rate[5]. FPF of Fluticasone/formoterol is significantly higher than other ICS/LABA combinations. It is expected that small particles of fluticason/formoterol could reach to the large/small airways easier than other ICS/LABA combinations even if these ICS/LABAs shows a similar efficacy for asthma treatment. However Asthma patients can struggle to use their pMDI inhalers correctly due to the need to properly co-ordinate the press and inhale, which can worsen their asthma and lead to exacerbations.

Flutiform K-haler is the first breath-actuated inhaled corticosteroid (ICS) long-acting β2-agonist (LABA) combination aerosol inhaler for adults and adolescents. The flutiform k-haler has been designed with patients in mind, requiring only a gentle inhalation to trigger the dose release, with the aim to help patients reduce critical errors and improve long-term outcomes.

Therefore, It is expected that Flutiform K-haler prevents exacerbation and improves symptom of Asthma. Especially it will be beneficial to patients who did not response to existing ICS/LABA DPI in Korea. This study is planned to examine the efficacy and safety of Flutiform K-haler in patients who are not adequately controlled by previous mid-dose ICS/LABA DPI treatment.

Study Design

Conditions

Asthma

Intervention

Brand Name: Flutiform K-haler

Status

Not yet recruiting

Source

Mundipharma Korea Ltd

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-10-16T10:39:13-0400

Clinical Trials [1610 Associated Clinical Trials listed on BioPortfolio]

Study of FLUTIFORM® VS Seretide® in Paediatric Subjects With Asthma

Study compares the efficacy and safety of FLUTIFORM® with Seretide® in the treatment of mild to moderate persistent asthma in pediatric subjects.

Study of FlutiForm® Versus Fluticasone Plus Formoterol in Adult Subjects With Severe Asthma

The study compares the efficacy and safety of FlutiForm® vs Flixotide® plus Foradil® in the treatment of severe persisent asthma in adult subjects.

New Combination Inhaler (FlutiForm HFA MDI 100/10 µg and 250/10 µg) in Patients With Asthma

The purpose of this study is to evaluate the long-term safety of the fixed combination asthma drug FlutiForm HFA MDI (containing fluticasone propionate and formoterol fumarate) in adult an...

An Open, Randomised, Parallel Group Multicentre Study to Compare the Efficacy and Safety of Flutiform® pMDI vs Fluticasone pMDI Plus Formoterol DPI in Adolescent and Adult Subjects With Mild to Moderate-severe Persistent, Reversible Asthma

Flutiform® compared with the individual components Flixotide® (Fluticasone) and Foradil® (Formoterol) in adolescent and adult patients.

A Phase 3, Multicenter, Open-Label Continuation Study in Moderate to Severe Asthmatic Subjects Who Completed FlutiForm HFA pMDI Study SKY2028-3-005

The objective of this study is to assess the long-term safety and efficacy of FlutiForm HFA pMDI 250/10 mcg bid in adolescents and adults with moderate to severe asthma who have completed ...

PubMed Articles [1098 Associated PubMed Articles listed on BioPortfolio]

Comparative effectiveness of generic and brand-name medication use: A database study of US health insurance claims.

To the extent that outcomes are mediated through negative perceptions of generics (the nocebo effect), observational studies comparing brand-name and generic drugs are susceptible to bias favoring the...

Competition and price among brand-name drugs in the same class: A systematic review of the evidence.

Some experts have proposed combating rising drug prices by promoting brand-brand competition, a situation that is supposed to arise when multiple US Food and Drug Administration (FDA)-approved brand-n...

Hot Topic: Precision Medicine for Asthma-Has the Time Come?

Asthma is a common inflammatory airway disease, which affects more than 300 million people worldwide. Although conventional drugs are effective for most of the patients with mild-to-moderate asthma, t...

The effects of tech and non-tech innovation on brand equity in China: The role of institutional environments.

Recently, innovation has been a key driver of brand equity. However, the emerging economies provide a dynamic institutional environment that makes it difficult to explore the relationship between inno...

Novel Insights on Sex-Related Differences in Asthma.

Asthma, a common respiratory disease that affects about 10% of the US population, represents a significant public health issue. In the last decade, cumulative evidence has demonstrated sex disparities...

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.

Adrenergic beta-2 agonist used as bronchodilator for emphysema, bronchitis and asthma.

More From BioPortfolio on "Efficacy and Safety of Flutiform K-haler in Patients With Uncontrolled Asthma Following Mid-dose ICS/LABA DPI Therapy"

Quick Search

Relevant Topic

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...


Searches Linking to this Trial