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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 |
Health Authority: | Poland: Ministry of Health |
Paediatric subjects with asthma |
Hypersensitivity Lung Diseases, Obstructive Respiratory Tract Diseases Lung Diseases Hypersensitivity, Immediate |
Formoterol Fluticasone Asthma Respiratory Hypersensitivity |
Anti-Inflammatory Agents Respiratory System Agents Neurotransmitter Agents Bronchial Diseases Immune System Diseases Adrenergic beta-Agonists Adrenergic Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |
Anti-Asthmatic Agents Anti-Allergic Agents Adrenergic Agonists Pharmacologic Actions Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Dermatologic Agents Bronchodilator Agents |