Advertisement

Topics

The Effect of HFA - Beclomethasone Dipropionate Qvar on Bronchial Hyperreactivity in Preschool Children

2014-07-24 14:11:01 | BioPortfolio

Summary

Respiratory diseases including Asthma are high prevalent among preschool children. Specific treatment, nowadays, include steroid inhalers and anti leukotrienes. It is known that the amount of the drug reaching small airways and lungs is bigger how much smaller the particles liberated by inhalers. Beclometasone is being used for treating asthma for 30 years. Lately emerged a new presentation of beclometasone, which liberates particles as small as 2.1 µ, that is supposed to reach the small airways at higher concentrations and be more suitable to patients who don't cooperate properly to the procedure of inhalation.

The investigators' group has reported successfully the possibility to perform Pulmonary Challenge tests (Adenosine, Methacholine and exercise) in tender age. Other studies reported relation between asthma control and reduction in airway hyperreactivity. The purpose of this study is to evaluate the efficacy of Beclometasone dipropionate - Qvar to reduce airways hyperreactivity in preschool children, as demonstrated by Adenosine challenge test.

Description

26 - 30 patients, between 3 -6 years old, mild asthmatics, with positive adenosine challenge test, will received in a randomized, double blind, cross over assignment Beclometasone dipropionate (100µ twice a day) or placebo, through an inhaler (autohaler) device, attached to a spacer device, during four consecutive weeks. Adenosine Challenge test will be performed another time at the end of this four weeks period. After 2 weeks with no medication (wash out period) the patients will receive the second intervention (beclometasone dipropionate or placebo) in a cross over manner and will be submitted to the last adenosine challenge test.

Clinical evaluation, resting spirometry and subjective evaluation through an analogical symptoms scale will be recorded in each visit.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Conditions

Asthma

Intervention

Beclomethasone dipropionate HFA, placebo

Location

Rambam Medical Center
Haifa
Israel

Status

Recruiting

Source

Rambam Health Care Campus

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:11:01-0400

Clinical Trials [1405 Associated Clinical Trials listed on BioPortfolio]

Study to Assess the Efficacy and Safety of Beclomethasone Dipropionate in Adolescent and Adult Patients 12 Years of Age and Older With Persistent Asthma

The primary objective of this study is to evaluate the efficacy of beclomethasone dipropionate administered via BAI at a dose strength of 40 or 80 mcg per oral inhalation (320 or 640 mcg/d...

Efficacy and Safety of Nebulised Beclomethasone Dipropionate Plus as Needed Salbutamol vs as Needed Salbutamol or as Needed Salbutamol/Beclomethasone Fixed Combination in Young Children With Asthma Symptoms

To demonstrate a superior efficacy of BDP plus rescue salbutamol suspension for nebulisation, compared to placebo plus rescue salbutamol, in the relief of symptoms of asthma in young child...

Real-world Effectiveness and Cost-effectiveness of Leading Inhaled Corticosteroids in Asthma Management

The objective of the study was to compare the effectiveness, cost-effectiveness and direct healthcare costs of managing asthma in patients with evidence of persistent asthma, following the...

A Safety and Efficacy Study of Beclomethasone Dipropionate Delivered Via Breath-Actuated Inhaler (BAI) or Metered-Dose Inhaler (MDI) in Participants Ages 5-11 Years Old With Persistent Asthma

This randomized, double-blind, double-dummy, placebo-controlled, parallel-group, 12-week study will evaluate the efficacy and safety of beclomethasone dipropionate (80 or 160 mcg/day) admi...

Childhood Asthma Research and Education (CARE) Network Trial - Treating Children to Prevent Exacerbations of Asthma (TREXA)

Asthma is a common, serious illness among children in the United States. It can be effectively controlled through the use of preventative medications and "rescue" medications, which are us...

PubMed Articles [1888 Associated PubMed Articles listed on BioPortfolio]

Pharmacokinetics of Beclomethasone Dipropionate Delivered by Breath-Actuated Inhaler and Metered-Dose Inhaler in Healthy Subjects.

Breath-actuated inhalers (BAIs) eliminate the need for hand-breath coordination required of pressurized metered-dose inhalers (MDIs). This pharmacokinetic study compared systemic exposure following be...

Development of pH-Dependent Nanospheres for Nebulisation- In vitro Diffusion, Aerodynamic and Cytotoxicity Studies.

The aim of this work was to evaluate the in vitro performance of nebulized nanosuspension formulation when nebulized using ultrasonic nebulizer. The present investigation deals with successful formula...

Menopausal asthma-much ado about nothing? An observational study.

Menopausal asthma is considered a distinct asthma phenotype. Our aim was to identify potential specific features of asthma in postmenopausal women in a cohort of Polish females.

Exploring the intersection of executive function and medication adherence in school-age children with asthma.

Asthma is one of the most common chronic diseases of childhood. For children with persistent asthma, asthma control is largely related to controller medication adherence. With increasing calls for chi...

Work-related asthma in a sample of subjects with established asthma.

To assess the impact of occupational exposure to irritants or sensitizers on the occurrence, recrudescence and worsening of asthma and to identify unrecognized cases of work related asthma (WRA) inclu...

Medical and Biotech [MESH] Definitions

An anti-inflammatory, synthetic glucocorticoid. It is used topically as an anti-inflammatory agent and in aerosol form for the treatment of ASTHMA.

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

Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.

An effect usually, but not necessarily, beneficial that is attributable to an expectation that the regimen will have an effect, i.e., the effect is due to the power of suggestion.

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).

More From BioPortfolio on "The Effect of HFA - Beclomethasone Dipropionate Qvar on Bronchial Hyperreactivity in Preschool Children"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

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...

Pediatrics
Pediatrics is the general medicine of childhood. Because of the developmental processes (psychological and physical) of childhood, the involvement of parents, and the social management of conditions at home and at school, pediatrics is a specialty. With ...


Searches Linking to this Trial