This is a comparator study to assess safety and efficacy of Flutiform compared with Fluticasone pMDI and Seretide pMDI in paediatric asthma patients with moderate to severe persistent, reversible asthma.
Who can participate
Age range
5 Years – 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 and Female subjects 5 to \<12 years old.
. Known history of moderate to severe persistent reversible asthma1 for ≥ 6 months prior to the screening visit.
. Demonstrated FEV1 of ≥ 60% to ≤ 90% for predicted normal values (Polgar 1971) during the screening period following appropriate withholding of asthma medications (if applicable):
. Documented reversibility of ≥ 15% in FEV1 in the screening period
. Current use of an inhaled corticosteroid for asthma at a stable dose for at least 4 weeks prior to the screening visit
. Inadequate asthma control on an ICS alone at a dose of ≤ 500 µg fluticasone equivalents/day, OR controlled asthma on an ICS-LABA combination at a ICS dose of ≤ 200 µg fluticasone equivalents/day
. Demonstrated satisfactory technique in the use of the pMDI and spacer device
. Can perform spirometry adequately
Exclusion criteria
. Near fatal or life-threatening (including intubation) asthma within the past year
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
To show superiority in the efficacy of Flutiform pMDI 50/5μg (2 puffs bid) versus fluticasone pMDI 50 μg (2 puffs bid).
. Hospitalisation or an emergency visit for asthma within the past 6 months
. History of systemic (injectable or oral) corticosteroid medication within 1 month of the screening visit
. Current or prior non-response or partial response only to an ICS-LABA combination1
. Evidence of a clinically unstable disease, as determined by medical history, clinical laboratory tests, and physical examination that, in the Investigator's opinion, preclude entry into the study. "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