An Exploratory Study to Characterise Changes in Airway Inflammation, Symptoms, Lung Function and Reliever Use in Adult Asthma Patients
Condition: Airway Inflammation; Asthma
MeSH terms: Asthma; Inflammation
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a randomised, active-comparator, open-label, parallel-group, multicentre phase IV
      exploratory study to characterise changes in airway inflammation, symptoms, lung function,
      and reliever use in asthma patients using SABA (salbutamol) or anti inflammatory reliever
      (SYMBICORT®) as reliever medication in addition to SYMBICORT as daily asthma controller.
      Eligible patients diagnosed with asthma at least 6 months prior to the Screening Visit (Visit
      1) and fulfilling all of the inclusion criteria and none of the exclusion criteria will
      continue into the Run-in Period. At Visit 2, patients will be assessed for randomisation
      criteria and, if met, will be randomised to receive either SYMBICORT as maintenance and
      reliever treatment or SYMBICORT as maintenance treatment and salbutamol as reliever treatment
      in a 1:1 ratio. Randomisation will be stratified by the patient's ongoing dose of inhaled
      corticosteroids [(ICS) low or medium] or long-acting β2-agonist (ICS/LABA) at study entry
    

Detailed description: 
      This is a randomised, active-comparator, open-label, parallel-group, multicentre phase IV
      exploratory study to characterise changes in airway inflammation, symptoms, lung function,
      and reliever use in asthma patients using SABA (salbutamol) or anti-inflammatory reliever
      (SYMBICORT®) as reliever medication in addition to SYMBICORT as daily asthma controller.
      Eligible patients diagnosed with asthma at least 6 months prior to the Screening Visit (Visit
      1) and fulfilling all of the inclusion criteria and none of the exclusion criteria will
      continue into the Run-in Period. During the run-in period, patients will take their
      maintenance medication (ie, SYMBICORT [100/6 or 200/6 μg, × 2 BID]) and reliever salbutamol
      [100 μg, PRN]) using the connected inhalers. At Visit 2, patients will be assessed for
      randomisation criteria and, if met, will be randomised to receive either SYMBICORT as
      maintenance and reliever treatment or SYMBICORT as maintenance treatment and salbutamol as
      reliever treatment in a 1:1 ratio. Randomisation will be stratified by the patient's ongoing
      dose of ICS (low or medium) or long-acting β2-agonist (LABA) at study entry. This study will
      include a minimum of 3 site visits. Patients will be requested to come to the study site for
      4 additional Event Visits (E1 to E4) at approximately 4-day intervals beginning after the
      first visit if they experience any one of the following 3 criteria: a) A severe exacerbation
      defined as use of systemic steroids for at least 3 days, emergency room visit, or inpatient
      hospitalisation due to asthma, b) Symptom worsening criteria based on CompEx evaluation - an
      asthma worsening identified by a combination of deteriorations in at least 2 variables
      (decrease in PEF of at least 15% compared with baseline, an increase of reliever medication
      of at least 1.5 occasions compared with baseline, or an increase in asthma symptoms of at
      least 1 compare with baseline or the absolute max score [=3]) at least 2 consecutive days, or
      c) A single day (in 24 hours) with 6 or more occasions of reliever medication use.

      The duration of participation in the study will be 26 to 28 weeks (maximum) for each
      individual patient, including a 2-week Run-in Period, followed by a 24-week randomised
      Treatment Period and an additional follow-up period if the Event Visits fall within the final
      2 weeks of the Treatment Period. The study plans to randomise a minimum of 60 patients to a
      maximum of 80 patients to achieve at least 54 patients completing the study. The study will
      be conducted at no less than 2 sites in the United Kingdom (UK). The estimated study duration
      is approximately 30 months.
    

Intervention name(s): SYMBICORT and salbutamol
Intervention type(s): Combination Product
Intervention description(s): Salbutamol is a short-acting β-agonist and SYMBICORT (fixed dose combination of inhaled corticosteroid plus long-acting β2-agonist) is an anti-inflammatory reliever for asthma. SYMBICORT will be given in a TURBOHALER. Salbutamol will be given in a pressurised metered dose inhaler.
Other intervention name(s): VENTOLIN (salbutamol); SYMBICORT (budesonide/formoterol)
Intervention MeSH terms: Budesonide; Albuterol; Formoterol Fumarate; Budesonide, Formoterol Fumarate Drug Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Airway inflammation; Anti-inflammatory reliever; SYMBICORT; Maintenance anti-inflammatory therapy; Reliever medication; Salbutamol