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| Sponsor: | Mundipharma Research Limited |
|---|---|
| Information provided by: | Mundipharma Research Limited |
| ClinicalTrials.gov Identifier: | NCT00475813 |
Purpose
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: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label |
| 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.
Eligibility| 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:
Contacts and Locations| Czech Republic | |
| Prague, Czech Republic | |
| France | |
| Laon, France | |
| Germany | |
| Wiesal, Germany | |
| Hungary | |
| Budapest, Hungary | |
| Poland | |
| Lublin 20-093, W. Chodzki 2, Poland | |
| Romania | |
| Bucharest, Romania | |
More Information
| ClinicalTrials.gov Identifier: | NCT00475813 History of Changes |
| Other Study ID Numbers: | FLT3502, 2006-005928-16 |
| Study First Received: | May 18, 2007 |
| Last Updated: | April 17, 2008 |
| Health Authority: | Poland: Ministry of Health |
|
Paediatric subjects with asthma |
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Formoterol Fluticasone Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists |
Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses Dermatologic Agents Anti-Allergic Agents Anti-Inflammatory Agents |