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Sponsored by: |
Mundipharma Research Limited |
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Information provided by: | Mundipharma Research Limited |
ClinicalTrials.gov Identifier: | NCT00734318 |
The study compares the efficacy and safety of FlutiForm® vs Flixotide® plus Foradil® in the treatment of severe persisent asthma in adult subjects.
Condition | Intervention | Phase |
---|---|---|
Asthma, Bronchial |
Drug: FlutiForm® (combination product of Fluticasone and Formoterol) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Double Blind, Double Dummy, Randomised, Multicentre, Four Arm Parallel Group Study to Assess the Efficacy and Safety of FlutiForm® pMDI 250/10µg (2 Puffs Bid) vs Fluticasone pMDI 250µg (2 Puffs Bid) Plus Formoterol pMDI 12µg (2 Puffs Bid) Administered Concurrently in Adult Subjects With Severe Persistent, Reversible Asthma. |
Estimated Enrollment: | 508 |
Study Start Date: | September 2008 |
Estimated Study Completion Date: | October 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
This is a study involving a 2 week run-in phase followed by an 8 week double blind treatment phase. During the run-in phase, subjects receive Flixotide®. In the treatment phase subjects will be randomised to one of the four treatment groups and will receive either high dose FlutiForm® and Foradil® plus Flixotide® placebo or low dose FlutiForm® plus Foradil® and Flixotide® placebo or Foradil® plus Flixotide® and FlutiForm® placebo or Flixotide® and FlutiForm® plus Foradil® placebo. Efficacy will be assessed by lung function tests, asthma symptoms, sleep disturbance due to asthma and rescue medication use. Safety will be assessed by adverse events, lab tests, ECGs and vital signs.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Demonstrated a FEV1 of ≥ 40% to ≤ 80% for predicted normal values (Quanjer et al., 1993) during the Screening Visit (Visit 1) and Randomisation Visit (Visit 3) following appropriate withholding of asthma medications (if applicable).
Written informed consent obtained.
Inclusion criteria required following run-in:
Exclusion criteria:
Current evidence or known history of any clinically significant disease or abnormality including uncontrolled coronary artery disease, congestive heart failure, myocardial infarction, or cardiac dysrhythmia.
'Clinically significant' is defined as any disease that, in the opinion of the Investigator, would put the subject at risk through study participation, or which would affect the outcome of the study.
Contact: Jill Kiteley | info@contact-clinical-trials.com | |
Contact: Margaret Wilson | info@contact-clinical-trials.com |
Hungary | |
Recruiting | |
SIOFOK, Hungary |
Responsible Party: | ( Mundipharma Research Limited ) |
Study ID Numbers: | FLT3503, 2007-001633-34 |
Study First Received: | August 13, 2008 |
Last Updated: | July 23, 2009 |
ClinicalTrials.gov Identifier: | NCT00734318 History of Changes |
Health Authority: | Hungary: National Institute of Pharmacy |
Severe asthma Fluticasone Formoterol |
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 |