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| Sponsor: | Mundipharma Research Limited |
|---|---|
| Information provided by: | Mundipharma Research Limited |
| ClinicalTrials.gov Identifier: | NCT00563056 |
Purpose
Flutiform® compared with the individual components Flixotide® (Fluticasone) and Foradil® (Formoterol) in adolescent and adult patients.
| Condition | Intervention | Phase |
|---|---|---|
|
Asthma Bronchiale |
Drug: Flutiform |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Open, Randomised, Parallel Group Multicentre Study to Compare the Efficacy & Safety of Flutiform® pMDI vs Fluticasone pMDI Plus Formoterol DPI in Adolescent & Adult Subjects With Mild to Moderate-severe Persistent, Reversible Asthma |
| Estimated Enrollment: | 200 |
| Study Start Date: | September 2007 |
| Study Completion Date: | January 2008 |
This is a study involving a 12 week treatment phase. During the treatment phase subjects receive Flutiform® or Flixotiole® and Foradil® as individual componements. 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: | 12 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion criteria:
Demonstrate a FEV1 of ≥40% to ≤85% for predicted normal values (Quanjer et al, 19931) during the screening phase following appropriate withholding of asthma medications (if applicable).
Exclusion criteria:
Contacts and Locations| Germany | |
| Research Site | |
| Kassel, Germany | |
| Hungary | |
| Research Site | |
| Erd, Hungary | |
| Netherlands | |
| Research site | |
| Nieuwegein, Netherlands | |
| Poland | |
| Research Site | |
| Krakow, Poland | |
| Romania | |
| Research Site | |
| Cluj-Napoca, Romania | |
| United Kingdom | |
| Research Site | |
| Chesterfield, United Kingdom | |
More Information
| Study ID Numbers: | FLT3505, 2007-001634-13 |
| Study First Received: | November 21, 2007 |
| Last Updated: | July 23, 2009 |
| ClinicalTrials.gov Identifier: | NCT00563056 History of Changes |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Romania: National Medicines Agency; Germany: Federal Institute for Drugs and Medical Devices; Hungary: National Institute of Pharmacy; Netherlands: Medicines Evaluation Board (MEB) |
|
Formoterol Fluticasone Asthma |
|
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 |