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Sponsored by: |
Johann Wolfgang Goethe University Hospitals |
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Information provided by: | Johann Wolfgang Goethe University Hospitals |
ClinicalTrials.gov Identifier: | NCT00543686 |
Explorative comparison of montelukast with inhaled steroids (fluticasone) to estimate responder profiles, in terms of symptom scores, rescue medication, increase of FEV1, in correlation to presence of allergy, bronchial hyperreactivity (PD20), exhaled NO, excretion of leukotrienes, response to RABA and laboratory parameters in patients with pre-school asthma i.e. asthma phenotypes.
Condition | Intervention | Phase |
---|---|---|
Asthma |
Drug: Intake of Montelukast Drug: Intake of Fluticasone |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | A Randomised Controlled Open-Label Phase IV Mono Centre Study to Compare the Response Profiles of Montelukast Versus Fluticasone in Children With Pre-School Asthma |
Estimated Enrollment: | 100 |
Study Start Date: | August 2007 |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
Montelukast
|
Drug: Intake of Montelukast |
2: Active Comparator
Fluticasone
|
Drug: Intake of Fluticasone |
Ages Eligible for Study: | 4 Years to 6 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Germany, Hessen | |
Goethe University, Department of Pulmonology | Recruiting |
Frankfurt, Hessen, Germany, 60590 | |
Contact: Stefan Zielen, M.D., Ph.D. 0049-69-6301 ext 83011 Stefan.Zielen@kgu.de | |
Contact: Tatjana Müller 0049-69-6301 ext 5381 Tatjana.Mueller@kgu.de | |
Principal Investigator: Stefan Zielen, M.D., Ph.D. |
Principal Investigator: | Stefan Zielen, Prof. Dr. | Johann Wolfgang Goethe-University Frankfurt, Zentrum für Kinderheilkunde I, Haus 32, Abt. Pneumologie |
Study ID Numbers: | 165/07/FFM |
Study First Received: | October 11, 2007 |
Last Updated: | October 12, 2007 |
ClinicalTrials.gov Identifier: | NCT00543686 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Pre-School Asthma Responder Profiles Fluticasone |
Montelukast Leukotriene Children with Pre-School Asthma |
Montelukast Hypersensitivity Lung Diseases, Obstructive Respiratory Tract Diseases Infectious Mononucleosis Lung Diseases |
Hypersensitivity, Immediate Fluticasone Asthma Leukotriene Antagonists Respiratory Hypersensitivity |
Anti-Inflammatory Agents Respiratory System Agents Bronchial Diseases Immune System Diseases Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Anti-Asthmatic Agents |
Anti-Allergic Agents Pharmacologic Actions Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Bronchodilator Agents Dermatologic Agents |