Pediatric Asthma Study Using Stepwise Treatment With Two Food And Drug Administration Approved Asthma Medications
Summary
This study was designed to evaluate if, in children with asthma, a stepwise treatment (five levels varying from once daily fluticasone propionate 100mcg until twice daily a fixed combination of salmeterol and fluticasone propionate 50/500 mcg) based on symptom scores alone results in a sub-optimal treatment when compared to treatment based on cumulative symptom scores and bronchial hyperresponsiveness (PD20 methacholine).
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Conditions
Asthma
Intervention
Salmeterol/Fluticasone propionate combination product, Fluticasone propionate
Location
GSK Investigational Site
Alkmaar
Netherlands
1815 JD
Status
Completed
Source
GlaxoSmithKline
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00158834
- Information obtained from ClinicalTrials.gov on July 15, 2010
Published on BioPortfolio: 2014-07-24T14:28:07-0400
Clinical Trials
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The purpose of the study is to characterize the pharmacokinetic profiles of fluticasone propionate and/or salmeterol when delivered as a single oral inhalation dose of Fp MDPI and FS MDPI.
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PubMed Articles
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Asthma is the most chronic inflammatory disease of the airways worldwide. Combination therapy with inhaled fluticasone and salmeterol is a common practice for the long-term management of asthma. Seret...
There is a scarcity of studies that assessed the association between adherence to combination therapy and asthma control in pediatric patients. The authors investigated the association between adheren...
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Medical and Biotech [MESH] Definitions
Fluticasone Propionate, Salmeterol Xinafoate Drug Combination
A drug combination of fluticasone and salmeterol that is used as an inhaler formulation to manage the symptoms of ASTHMA and CHRONIC OBSTRUCTIVE PULMONARY DISEASE.
Testosterone Propionate
An ester of TESTOSTERONE with a propionate substitution at the 17-beta position.
Fluticasone
A STEROID with GLUCOCORTICOID RECEPTOR activity that is used to manage the symptoms of ASTHMA; ALLERGIC RHINITIS, and ATOPIC DERMATITIS.
Levopropoxyphene
A propionate derivative that is used to suppress coughing.
Salmeterol Xinafoate
A selective ADRENERGIC BETA-2 RECEPTOR agonist that functions as a BRONCHODILATOR when administered by inhalation. It is used to manage the symptoms of ASTHMA and CHRONIC OBSTRUCTIVE PULMONARY DISEASE.
