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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 [1584 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 [1947 Associated PubMed Articles listed on BioPortfolio]

Pharmacokinetics of Co-Suspension Delivery Technology Budesonide/Glycopyrronium/Formoterol Fumarate Dihydrate (BGF MDI) and Budesonide/Formoterol Fumarate Dihydrate (BFF MDI) Fixed-Dose Combinations Compared With an Active Control: A Phase 1, Randomized, Single-Dose, Crossover Study in Healthy Adults.

This randomized, phase 1, single-dose, crossover study (NCT02189304) compared the 12-hour pharmacokinetic (PK) and safety profiles of budesonide/glycopyrronium/formoterol fumarate dihydrate metered do...

Safety and pharmacokinetics of budesonide/glycopyrronium/formoterol fumarate dihydrate metered dose inhaler (BGF MDI) in healthy adult subjects of Japanese descent.

BGF MDI, a budesonide, glycopyrronium, and formoterol fumarate dihydrate triple fixed-dose combination metered dose inhaler formulated using co-suspension delivery technology, is currently in Phase II...

As-Needed Budesonide-Formoterol versus Maintenance Budesonide in Mild Asthma.

Patients with mild asthma often rely on inhaled short-acting β-agonists for symptom relief and have poor adherence to maintenance therapy. Another approach might be for patients to receive a fast-act...

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...

Inhaled Combined Budesonide-Formoterol as Needed in Mild Asthma.

In patients with mild asthma, as-needed use of an inhaled glucocorticoid plus a fast-acting β-agonist may be an alternative to conventional treatment strategies.

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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