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
Overview
- Phase
- Phase 3
- Intervention
- Flutiform
- Conditions
- Asthma
- Sponsor
- Mundipharma Research Limited
- Enrollment
- 261
- Locations
- 1
- Primary Endpoint
- non-inferiority in the efficacy of FlutiForm®
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
A comparator study to assess safety and efficacy of Flutiform® compared with symbicort turbohaler in asthma patients with moderate to severe persistent, reversible asthma.
Detailed Description
This is a study involving a 2-4 week run-in phase followed by a 12 week double blind treatment phase. During the run-in phase, subjects receive Flixotide®. In the treatment phase subjects will be randomised to one of the two treatment groups and will receive either FlutiForm® and placebo inhaler for symbicort® turbohaler® or symbicort® turbohaler® and placebo inhaler for Flutiform ® . Efficacy will be assessed by lung function tests, asthma symptoms, sleep disturbance due to asthma and rescue medication use. Safety will be assessed by adverse events, lab tests, ECGs and vital signs.
Investigators
Eligibility Criteria
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:
- •Treatment with an inhaled corticosteroid (ICS) at a dose of 250 - 1000 µg fluticasone or equivalent OR Treatment wth ICS at a dose of 200-500 µg fluticasone or equivalent in combination with a Long Acting β2-Agonist (LABA).
- •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).
- •No β2-agonist use on day of testing
- •No use of inhaled combination asthma therapy on day of testing.
- •Inhaled corticosteroids are allowed on day of testing.
- •Documented reversibility of ≥ 15% in FEV1 at visit 1 or visit
- •Demonstrated satisfactory technique in the use of the study medications i.e. pMDI and Dry Powder Inhaler (DPI) devices.
Exclusion Criteria
- Not provided
Arms & Interventions
Inhaler
Intervention: Flutiform
Inhaler
Intervention: Symbicort Turbohaler
inhaler
Symbicort
Intervention: Symbicort Turbohaler
Outcomes
Primary Outcomes
non-inferiority in the efficacy of FlutiForm®
Time Frame: baseline to the end of the 12 week treatment
To show non-inferiority in the efficacy of FlutiForm® pMDI 125/5 µg (2 puffs bid) vs Symbicort® Turbohaler® 200/6 µg (2 puffs bid), based on the mean change in the pre morning dose value of forced expiratory volume in the first second (FEV1) from baseline (end of run-in period) to the end of the 12 week treatment period.
Secondary Outcomes
- Additional efficacy and safety assessments