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 range
12 Years
Sex
ALL
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Comparison of mean Forced Expriatory Volume in the 1st second (FEV1) values.
. 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.
. 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.