8 results
The purpose of this study is to evaluate whether aztreonam solution for inhalation (AZLI) is safe and effective for the treatment and complete eradication of a lung infection with PA (Pseudomonas aeruginosa) in patients with Cystic Fibrosis (CF) and…
The primary objective of this study is to assess the comparative safety and efficacy ofAztreonam Lysine for Inhalation (AZLI) and Tobramycin Nebuliser Solution (TNS) in adultand pediatric cystic fibrosis (CF) patients aged 6 years or older with…
Primary- To evaluate the safety and tolerability of long-term intermittent use of lasmiditan for the acute treatment of migraine in pediatric patients.Key Secondary- To evaluate the efficacy of intermittently dosed lasmiditan in the treatment of…
Primary: - To evaluate the efficacy of 2 dose quantities of lasmiditan on migraine headache pain freedom compared to placebo - To evaluate the consistency of response to 2 dose quantities of lasmiditan compared to placeboSecondary: - To evaluate the…
Primary: To evaluate the efficacy of FF/UMEC/VI to reduce the annual rate of moderate and severe exacerbations compared with dual therapy of FF/VI or UMEC/VI in subjects with COPD. Secondary: Long term safety and other efficacy parameters.
Primary:To compare the effect of UMEC/VI (62.5/25 mcg once daily) with UMEC (62.5 mcg once daily) on lung functionSecondary:To compare UMEC/VI, UMEC with salmeterol (50 mcg twice daily) on patient reported outcomes and on other COPD efficacy…
Efficacy and safety.
Primary- To test the hypothesis that lasmiditan high dose is superior to placebo in the acute treatment of a migraine attack in pediatric patients >=6 to <18 years of ageKey Secondary- To test the hypothesis that lasmiditan medium dose…