Summary:
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
Qualified Participants Must:- Be female or male aged ≥4 years at the time of informed consent
- 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 last 4 weeks before Visit 1:
- Medium-to-high-dose inhaled corticosteroid (ICS)
- Medium-to-high-dose ICS and 1 additional maintenance therapy from the following: leukotriene receptor antagonists (LTRA), long-acting muscarinic antagonists (LAMA), or theophylline
- Low-to-high-dose ICS in combination with long-acting β2-adrenoreceptor agonist (LABA) with or without one additional maintenance therapy from the following: LTRA, LAMA, or theophyllinA documented history of at least 1 severe asthma exacerbation within 12 months before Visit 1
Qualified Participants May Receive:
Compensation of $50 per visit for time and travel
All study-related procedures at no cost to the participant