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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00456313 |
This multi centre, double blind, comparator controlled, parallel group study is to determine whether asthma treatment with high doses of fluticasone propionate (FP) redirects a Th2/ eosinophil response towards a more treatment resistant neutrophil/ monocyte response and whether this occurs to a lesser extent in asthmatic subjects treated with the combination product of salmeterol and fluticasone propionate (SFC). The primary endpoint is the mean change in priming of blood neutrophils assessed by marker A17. After a run-in period of 4 weeks subjects will enter a 24 weeks high dose treatment (FP 500 mcg bd) or a 12 week medium-dose treatment with FP 250 mcg bd followed by a 12 week treatment with SFC 50/ 250 mcg. At the visits lung function measurements, ACT, eNO measurements and a blood sample will be performed. A total of 50 randomised subjects are planned to be recruited in this study
Condition | Intervention | Phase |
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Asthma |
Drug: FLIXOTIDE and SERETIDE |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Rationale for Therapy With Low Dose Steroids Combined With Long-Acting beta2-Agonists in Patients With Allergic Asthma: Redirecting Innate Immune Responses by Long-Term Treatment With High Doses of Inhaled Steroids |
Estimated Enrollment: | 50 |
Study Start Date: | December 2007 |
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion:
Inclusion criteria treatment period:
Exclusion criteria run-in period:
Exclusion criteria treatment period:
Netherlands | |
GSK Investigational Site | |
UTRECHT, Netherlands, 3582 KE | |
GSK Investigational Site | |
UTRECHT, Netherlands, 3584 CX |
Study Director: | GSK Clinical Trials, Prof. dr. | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | SAM109352 |
Study First Received: | April 3, 2007 |
Last Updated: | October 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00456313 |
Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
salmeterol/fluticasone propionate combination product innate immune response |
neutrophil priming asthma fluticasone propionate |
Hypersensitivity Lung Diseases, Obstructive Salmeterol Respiratory Tract Diseases Lung Diseases |
Hypersensitivity, Immediate Fluticasone Asthma Respiratory Hypersensitivity |
Anti-Inflammatory Agents Respiratory System Agents Bronchial Diseases Immune System Diseases Physiological Effects of Drugs Anti-Asthmatic Agents Anti-Allergic Agents |
Pharmacologic Actions Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Bronchodilator Agents Dermatologic Agents |