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Sponsored by: |
Mundipharma Research Limited |
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Information provided by: | Mundipharma Research Limited |
ClinicalTrials.gov Identifier: | NCT00475813 |
Study compares the efficacy and safety of FLUTIFORM® with Seretide® in the treatment of mild to moderate persistent asthma in pediatric subjects.
Condition | Intervention | Phase |
---|---|---|
Asthma |
Drug: FLUTIFORM® (Formoterol fumarate / Fluticasone propionate) |
Phase III |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Enrollment: | 211 |
Study Start Date: | March 2007 |
Study Completion Date: | February 2008 |
Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
This is a study involving a 12 week treatment phase followed by a 6 month extension phase. During the treatment phase subjects receive FLUTIFORM® or Seretide®. In the extension phase all subjects receive FLUTIFORM®. Efficacy will be assessed by lung function tests and asthma symptoms, sleep disturbance. Safety will be assessed by adverse events, vital signs, lab tests and ECGs.
Ages Eligible for Study: | 4 Years to 12 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Demonstrate a FEV1 of ≥60% to ≤80% of predicted normal values (Zapletal, 1977) during the screening phase following appropriate withholding of asthma medications (if applicable).
Exclusion Criteria:
Czech Republic | |
Prague, Czech Republic | |
France | |
Laon, France | |
Germany | |
Wiesal, Germany | |
Hungary | |
Budapest, Hungary | |
Poland, W. Chodzki 2 | |
Lublin 20-093, W. Chodzki 2, Poland | |
Romania | |
Bucharest, Romania |
Study ID Numbers: | FLT3502, 2006-005928-16 |
Study First Received: | May 18, 2007 |
Last Updated: | April 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00475813 History of Changes |
Health Authority: | Poland: Ministry of Health |
Paediatric subjects with asthma |
Anti-Inflammatory Agents Neurotransmitter Agents Bronchial Diseases Adrenergic Agents Adrenergic beta-Agonists Anti-Asthmatic Agents Asthma Anti-Allergic Agents Adrenergic Agonists Lung Diseases, Obstructive |
Hypersensitivity Respiratory Tract Diseases Lung Diseases Hypersensitivity, Immediate Fluticasone Formoterol Peripheral Nervous System Agents Bronchodilator Agents Respiratory Hypersensitivity |
Anti-Inflammatory Agents Respiratory System Agents Neurotransmitter Agents Bronchial Diseases Adrenergic Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Adrenergic Agonists Hypersensitivity Lung Diseases, Obstructive Respiratory Tract Diseases Therapeutic Uses Fluticasone Formoterol |
Dermatologic Agents Adrenergic beta-Agonists Immune System Diseases Asthma Anti-Asthmatic Agents Anti-Allergic Agents Pharmacologic Actions Autonomic Agents Lung Diseases Hypersensitivity, Immediate Peripheral Nervous System Agents Bronchodilator Agents Respiratory Hypersensitivity |