An Open, Randomised, Parallel Group Multicentre Study to Compare the Efficacy and Safety of Fluti… (NCT00563056) | Clinical Trial Compass
CompletedPhase 3
An Open, Randomised, Parallel Group Multicentre Study to Compare the Efficacy and Safety of Flutiform® pMDI vs Fluticasone pMDI Plus Formoterol DPI in Adolescent and Adult Subjects With Mild to Moderate-severe Persistent, Reversible Asthma
Flutiform® compared with the individual components Flixotide® (Fluticasone) and Foradil® (Formoterol) in adolescent and adult patients.
Who can participate
Age range12 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Male or female subjects at least 12 years or older (females less than one year post-menopausal must have a negative serum or urine pregnancy test recorded at the screening visit prior to the first dose of study medication, be non-lactating, and willing to use adequate and highly effective methods of contraception throughout the study if they are sexually active. A highly effective method of birth control is defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as sterilization, implants, injectables, combined oral contraceptives, some IUDs (Intrauterine Device, hormonal), sexual abstinence or vasectomised partner).
✓. Known history of mild to moderate-severe persistent, reversible asthma for ≥ 6 months prior to the screening visit.
✓. 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).
✓. Documented reversibility of ≥15% in FEV1 in the screening phase.
✓. Demonstrate satisfactory technique in the use of the study medications.
✓. Willing and able to enter information in the diary and attend all study visits.
✓. Willing and able to substitute study medication for their pre study prescribed asthma medication for the duration of the study.
✓. Written informed consent obtained
Exclusion criteria
✕. Near fatal or life-threatening (including intubation) asthma within the past year.
What they're measuring
1
Comparison of mean Forced Expriatory Volume in the 1st second (FEV1) values.
✕. Hospitalization or an emergency visit for asthma within the past year.
✕. History of systemic (oral or parenteral) corticosteroid medication within 1 month before the Screening Visit.
✕. History of omalizumab use within the past 6 months.
✕. History of leukotriene receptor antagonist use, e.g. montelukast, or theophylline within the past week.
✕. Current evidence or 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 patient at risk through study participation, or which would affect the outcome of the study.
✕. In the investigators opinion a clinically significant upper or lower respiratory infection within 4 weeks prior to the Screening Visit.