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A Study in Asthmatic Children (6 to <12 Yrs) Comparing Single Doses of Formoterol and Foradil® Evaluating Efficacy

2014-08-27 03:13:14 | BioPortfolio

Summary

This purpose of the study is to investigate the bronchodilating effects of 3 different dosages of formoterol given in combination with budesonide as Symbicort pMDI.

Description

A Phase 2, randomized, blinded, 5-period cross-over, placebo and active controlled, multicenter, dose-finding study comparing single doses of formoterol 2.25 µg, 4.5 µg, and 9 µg delivered via Symbicort pMDI and Foradil® 12 µg evaluating the relative bronchodilating effects and safety in children.

Study Design

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

Conditions

Asthma

Intervention

formoterol/budesonide, formoterol/budesonide, placebo/budesonide, Foradil

Status

Not yet recruiting

Source

AstraZeneca

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:13:14-0400

Clinical Trials [1535 Associated Clinical Trials listed on BioPortfolio]

Effect of Budesonide / Formoterol Combination in Repeated AMP Provocations

The aim is to study whether the budesonide component within the budesonide/ formoterol combination inhaler has additive value in a model of "slow onset acute asthma" , namely three AMP pro...

Bioequivalence Study of Budesonide/Formoterol Easyhaler and Symbicort Turbohaler in Asthmatics

The purpose of this study is to compare the test product Budesonide/formoterol Easyhaler with the marketed product Symbicort Turbohaler in terms of the drug absorbed into the bloodstream.

Pharmacokinetic Pilot Study on Budesonide/Formoterol Device-metered Dry Powder Inhaler

The aim of this pilot study is to assess the methodology, practical arrangements and pulmonary absorption with charcoal blockage for the future bioequivalence studies. In addition, PK of b...

Effects of Budesonide & Budesonide/Formoterol on Smoking Asthmatic Subjects

A reduced response to inhaled corticosteroids (ICS) has been reported in smoking compared to non-smoking asthmatic patients. However, the comparative response to other currently prescribe...

Efficacy of Symbicort Versus Its Monocomponents - SPRUCE 160/4.5

The purpose of this study is to compare Symbicort with budesonide alone and with formoterol alone in the treatment of asthma in adolescents and adults

PubMed Articles [1893 Associated PubMed Articles listed on BioPortfolio]

On the pharmacokinetics of two inhaled budesonide/formoterol combinations in asthma patients using modeling approaches.

Dry powder inhalers containing the budesonide/formoterol combination have currently a well-established position among other inhaled products. Even though their efficacy mainly depends on the local con...

Budesonide instillation immediately after reperfusion ameliorates ischemia/reperfusion-induced injury in the transplanted lung of rat.

Lung ischemia-reperfusion injury (LIRI) after lung transplantation can lead to primary graft dysfunction. Budesonide can improve endothelial function to reduce lung injury. This study was aimed to exa...

Inhaled Budesonide Does Not Affect Hypoxic Pulmonary Vasoconstriction at 4559 Meter of Altitude.

Berger, Marc Moritz, Franziska Macholz, Peter Schmidt, Sebastian Fried, Tabea Perz, Daniel Dankl, Josef Niebauer, Peter Bärtsch, Heimo Mairbäurl, and Mahdi Sareban. Inhaled budesonide does not affec...

Intranasal Budesonide and Quality of Life in Pediatric Sleep-Disordered Breathing: A Randomized Controlled Trial.

Objective To study the efficacy of budesonide nasal spray on the health-related quality of life and symptoms among children with sleep-disordered breathing. Study Design Randomized, parallel, double-b...

Effects of fluticasone propionate and budesonide on the expression of immune defense genes in bronchial epithelial cells.

COPD patients have increased risk of pneumonia when treated with fluticasone propionate (FP), whereas this is generally not the case with budesonide (BUD) treatment. We hypothesized that BUD and FP di...

Medical and Biotech [MESH] Definitions

A pharmaceutical preparation of budesonide and formoterol fumarate that is used as an ANTI-ASTHMATIC AGENT and for the treatment of CHRONIC OBSTRUCTIVE PULMONARY DISEASE.

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

A pharmaceutical preparation of mometasone furoate and formoterol fumarate that is used as an inhaled dosage form for the treatment of ASTHMA.

An ADRENERGIC BETA-2 RECEPTOR AGONIST with a prolonged duration of action. It is used to manage ASTHMA and in the treatment of CHRONIC OBSTRUCTIVE PULMONARY DISEASE.

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

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