A Long-term, Randomized, Double-blind, Multicenter, Parallel-group, Phase III Study Evaluating the Efficacy and Safety of PT027 Compared to PT007 Administered as Needed in Response to Symptoms in Symptomatic Adults and Children 4 Years of Age or Older With Asthma
Criteria:- Be female or male aged 4 years or older at time of enrollment
- Have a physician diagnosis of asthma documented for at least 1 year
- Have a documented history of at least 1 severe asthma exacerbation within 12 months before Visit 1
- Be receiving 1 of the following scheduled asthma maintenance therapies for 3 months with stable dosing for at least the 4 weeks before Visit 1:
- Medium-to-high dose inhaled corticosteroid
- Medium to high dose inhaled corticosteroid and 1 additional maintenance therapy from the following: LTRA, LAMA, or theophylline
- Low to high dose inhaled corticosteroid in combination with LABA with or without one additional maintenance therapy from the following: LTRA, LAMA, or theophylline
- A documented history of at least 1 severe asthma exacerbation within 12 months before Visit 1