7 results
The primary purpose of the study is to investigate whether the new 20 mg capsule of Orfadin® (nitisinone) has a similar bioavailability in the body (gives the same concentration in the blood) as two of the marketed capsules of 10 mg. The secundary…
The primary objective of this study is to show bioequivalence between nitisinone oral suspension and nitisinone capsules.Secondary objectives of this study are:- To assess the effect of food on the bioavailability of nitisinone oral suspension.- To…
The primary objective of this study is to evaluate the dose response, dose interval, efficacy, and safety of GSK961081 by studying three QD doses and three BID doses in subjects with COPD. The study will also evaluate the population PK, systemic PK-…
Primary: Efficacy of FF/GW642444 100/25 mcg once daily in comparison with that of FP/salmeterol 250/50 mcg twice daily during 24 weeks.Secundary: Safety and tolerability.
To demonstrate superiority of tiotropium vs. salmeterol in reducing exacerbations which are an important patient outcome because they are a major cause of morbidity from COPD. In addition, they are associated with a more rapid decline in lung…
With intervention with bronchodilators (usual care bronchodilators for COPD subjects), in one study histamine and in one study steroids, we want to investigate the respons on inspiratory lung function parameter like the FIV1 and also investigate…
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…