Efficacy of Symbicort Versus Its Monocomponents - SPRUCE 80/4.5
Summary
The purpose of this study is to compare Symbicort with its monocomponents budesonide and formoterol in the treatment of asthma in children and adults
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Conditions
Asthma
Intervention
budesonide/formoterol, budesonide, formoterol
Status
Completed
Source
AstraZeneca
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00651651
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Budesonide
A glucocorticoid used in the management of ASTHMA, the treatment of various skin disorders, and allergic RHINITIS.
Asthma, Exercise-induced
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).
Anti-asthmatic Agents
Drugs that are used to treat asthma.
Orciprenaline
A beta-adrenergic agonist used in the treatment of asthma and bronchospasms.
Tretoquinol
An adrenergic beta-agonist used as a bronchodilator agent in asthma therapy.
Clinical Trials
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...
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
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...
PubMed Articles
Once- vs Twice-Daily Budesonide/Formoterol in 6- to 15-Year-Old Patients With Stable Asthma.
Objective: To assess efficacy/tolerability of once-daily budesonide/formoterol pressurized metered-dose inhaler (pMDI) versus budesonide pMDI (primary) and twice-daily budesonide/formoterol (secondary...
Effects of formoterol-budesonide on airway remodeling in patients with moderate asthma.
Aim:To evaluate the effect of inhaled formoterol-budesonide on airway remodeling in adult patients with moderate asthma.Methods:Thirty asthmatic patients and thirty control subjects were enrolled. Ast...
ABSTRACT: BACKGROUND: There are no published studies that have compared bronchodilatory effect of inhaled budesonide/formoterol combination with budesonide/salbutamol delivered by metered dose inhaler...
Budesonide added to formoterol contributes to improved exercise tolerance in patients with COPD.
BACKGROUND: Breathlessness and exercise intolerance frequently impact the daily life of patients with COPD. METHODS: This double-blind, multicentre, three-period crossover study randomised 111 patient...
BACKGROUND AND OBJECTIVE: Inhaled glucocorticoids and long acting β2 -agonists reduce airway inflammation. It is unclear if this effect is based on the local action of the drugs or is due to a system...
