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 range12 Years
SexALL
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Inclusion criteria
âś“. Male or female subjects at least 12 years old
âś“. 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).
✓. Documented reversibility of ≥ 15% in FEV1 at visit 1 or visit 2.
âś“. Demonstrated satisfactory technique in the use of the study medications i.e. pMDI and Dry Powder Inhaler (DPI) devices.
âś“. Willing \& able to enter information in the electronic diary \& attend all study visits.
âś“. Willing \& able to substitute study medication for their pre study prescribed asthma medication for the duration of the study.
Exclusion criteria
âś•. Near fatal or life-threatening (including intubation) asthma within the past year.
What they're measuring
1
non-inferiority in the efficacy of FlutiForm®
Timeframe: baseline to the end of the 12 week treatment
âś•. Hospitalisation or an emergency visit for asthma within the 4 weeks before the Screening Visit.
âś•. Known history of systemic (injectable or oral) corticosteroid medication use within 1 month of the Screening Visit.
âś•. Known history of omalizumab use within the past 6 months.
âś•. 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.
âś•. In the investigator's opinion a clinically significant upper or lower respiratory infection within 4 weeks prior to the Screening Visit.