Assessment of the Efficacy and Safety of FlutiForm® pMDI 125/5 µg (2 Puffs Bid) Versus Symbicort®… (NCT01099722) | Clinical Trial Compass
CompletedPhase 3
Assessment of the Efficacy and Safety of FlutiForm® pMDI 125/5 µg (2 Puffs Bid) Versus Symbicort® Turbohaler® 200/6 µg (2 Puffs Bid) in Adolescent and Adult Subjects With Moderate to Severe Persistent, Reversible Asthma
A comparator study to assess safety and efficacy of Flutiform® compared with symbicort turbohaler in asthma patients with moderate to severe persistent, reversible asthma.
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 old
. Female subjects less than 1 year post-menopausal must have a negative urine pregnancy test recorded at the screening visit prior to the first dose of study medication, be non-lactating, \& willing to use adequate \& highly effective methods of contraception throughout the study. 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 \& correctly such as sterilisation, implants, injectables, combined oral contraceptives, some IUDs (Intrauterine Device, hormonal), sexual abstinence or vasectomised partner.
. Known history of moderate to severe persistent, reversible asthma for ≥ 6 months prior to the Screening Visit characterised by:
. Demonstrated a FEV1 of ≥ 50% to ≤ 80% for predicted normal values (Quanjer et al., 1993 (adults), \& 1995 (adolescents)) during the Screening Period (Visit 1 or Visit 2) following appropriate withholding of asthma medications (if applicable).
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
non-inferiority in the efficacy of FlutiForm®
Timeframe: baseline to the end of the 12 week treatment
. Documented reversibility of ≥ 15% in FEV1 at visit 1 or visit 2.
. Demonstrated satisfactory technique in the use of the study medications i.e. pMDI and Dry Powder Inhaler (DPI) devices.
. Willing \& able to enter information in the electronic diary \& attend all study visits.
. Willing \& able to substitute study medication for their pre study prescribed asthma medication for the duration of the study.
Exclusion criteria
. Near fatal or life-threatening (including intubation) asthma within the past year.
. Hospitalisation or an emergency visit for asthma within the 4 weeks before the Screening Visit.
. Known history of systemic (injectable or oral) corticosteroid medication use within 1 month of the Screening Visit.
. Known history of omalizumab use within the past 6 months.
. 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.
. In the investigator's opinion a clinically significant upper or lower respiratory infection within 4 weeks prior to the Screening Visit.