Budesonide Inhalation Suspension for Acute Asthma in Children

02:41 EDT 23rd October 2014 | BioPortfolio

Summary

The purpose of this study is to determine whether the addition of budesonide inhalation suspension (BIS) to the standard therapy of albuterol, ipratropium bromide, and systemic corticosteroids (SCS) for moderate to severe asthma flares in children reduces asthma severity more rapidly than standard therapy alone.

Description

Context: Acute asthma is a leading cause of emergency department (ED) visits and hospitalizations. Although standard therapy for acute asthma includes systemic corticosteroids (SCS), these drugs take many hours to have an effect. Recent studies demonstrate that inhaled corticosteroids (ICS) may improve patients' asthma severity more rapidly than SCS and may decrease hospitalizations. Only a few small studies have evaluated ICS added to standard therapy for acute asthma in children.

Objective: To determine if adding the nebulized steroid budesonide to standard therapy including SCS improves patients' asthma severity faster than standard therapy alone and leads to fewer hospitalizations.

Study Design/Setting/Participants: A double-blind, randomized, controlled trial of budesonide inhalation suspension (BIS) versus placebo for children 2 to 18 years of age who present to a tertiary care, urban pediatric ED with a moderate to severe asthma flare.

Intervention: Participants will receive standard therapy including SCS, albuterol, and ipratropium bromide and will be randomly assigned to also receive either nebulized BIS or saline.

Study Measures: Differences in asthma scores, vital signs, and the need for hospitalization will be compared between treatment groups.

Study Design

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

Conditions

Asthma

Intervention

Budesonide inhalation suspension (0.5 mg/2mL)

Location

Children's Hospital of Philadelphia Emergency Department
Philadelphia
Pennsylvania
United States
19104

Status

Completed

Source

Children's Hospital of Philadelphia

Results (where available)

View Results

Links

Clinical Trials [1112 Associated Clinical Trials listed on BioPortfolio]

Long Term Safety & Efficacy of Budesonide Inhalation Suspension in Japanese Children With Bronchial Asthma

This study is as an extension study of SD-004-0765, to assess the safety profile of long-term use of budesonide inhalation suspension in Japanese young children with bronchial asthma. Ch...

A Study of 2 Doses of MAP0010 in Adult Asthmatics

The purpose of this study is to examine the blood levels of two doses of MAP0010 (a corticosteroid) and two doses of an approved corticosteroid in adult asthma and safety with twice daily ...

A Comparative Study Between Foraseq And Formoterol/Budesonide Inhalation Capsules in Patients With Asthma

This study primary objective is to compare the impact of two products containing budesonide and formoterol as individual capsules with inhalation powder for the pulmonary function of subje...

Adults With Moderate to Severe Asthma

A study to compare the safety and effectiveness of 5 different ways of taking Pulmicort when given to asthma patients aged 12 years and above.

A Study Investigating the Tolerability and Pharmacokinetics of Submicron Budesonide in Children 4 Through 11 Years Old With a History of Mild-To-Moderate Stable Asthma

This Phase 2 study will investigate the tolerability of submicron budesonide at three doses in volunteers with a diagnosis and history of mild-to-moderate stable asthma and evaluate the ph...

PubMed Articles [1700 Associated PubMed Articles listed on BioPortfolio]

Comparing clinical efficacy of Symbicort versus Pulmicort in reducing asthma symptom and improving its control.

Recently, higher efficacy of the combination of long-acting beta2-adrenoceptor agonist and inhaled corticosteroids on controlling asthma symptoms has been hypothesized. This study aimed to examine the...

Efficacy and Safety of Oral Budesonide Suspension in Pediatric Patients with Eosinophilic Esophagitis.

No treatment has been approved by the US Food and Drug Administration for eosinophilic esophagitis (EoE). We investigated the efficacy and safety of a new formulation of oral budesonide suspension (OB...

Budesonide dry powder for inhalation: effects of leucine and mannitol on the efficiency of delivery.

Abstract Objective: The aim of this study was to develop a budesonide dry powder for inhalation using l-leucine and l-leucine - sieved mannitol as a carrier. Materials and methods: Budesonide and l-le...

Respiratory disease associated with occupational inhalation to hop (Humulus lupulus) during harvest and processing.

There is little published evidence for occupational respiratory disease caused by hop dust inhalation. In the United States, hops are commercially produced in the Pacific Northwest region.

Role of budesonide/formoterol maintenance and reliever therapy: a pragmatic study.

Many studies have demonstrated the efficacy of budesonide/formoterol (BUD/FORM) for Maintenance and Reliever Therapy (SMART®) for asthma control. However, there are concerns regarding its over-use an...

Medical and Biotech [MESH] Definitions

A glucocorticoid used in the management of ASTHMA, the treatment of various skin disorders, and allergic RHINITIS.

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).

Tests involving inhalation of allergens (nebulized or in dust form), nebulized pharmacologically active solutions (e.g., histamine, methacholine), or control solutions, followed by assessment of respiratory function. These tests are used in the diagnosis of asthma.

Inhalation of oxygen aimed at restoring toward normal any pathophysiologic alterations of gas exchange in the cardiopulmonary system, as by the use of a respirator, nasal catheter, tent, chamber, or mask. (From Dorland, 27th ed & Stedman, 25th ed)

A variety of devices used in conjunction with METERED DOSE INHALERS. Their purpose is to hold the released medication for inhalation and make it easy for the patients to inhale the metered dose of medication into their lungs.

More From BioPortfolio on "Budesonide Inhalation Suspension for Acute Asthma in Children"

Search BioPortfolio:
Loading
Advertisement

Relevant Topics

Pulmonary
Latest News Clinical Trials Research Drugs Reports Corporate
Pulmonary relating to or associated with the lungs eg Asthma, chronic bronchitis, emphysema, COPD, Cystic Fibrosis, Influenza,  Lung Cancer, Pneumonia, Pulmonary Arterial Hypertension, Sleep Disorders etc Follow and track Lung Cancer News ...

Pediatrics
Latest News Clinical Trials Research Drugs Reports Corporate
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 ...

Allergies
Latest News Clinical Trials Research Drugs Reports Corporate
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...

Advertisement