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 range5 Years – 12 Years
SexALL
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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
✕. 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
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).
✕. 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