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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: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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
| ClinicalTrials.gov Identifier: | NCT00563056 History of Changes |
| Other Study ID Numbers: | FLT3505, 2007-001634-13 |
| Study First Received: | November 21, 2007 |
| Last Updated: | July 23, 2009 |
| 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 |
|
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 |