Promoter: gsk
gsk Update Il y a 5 ans

An integrated review to evaluate dose response of umeclidinium (GSK573719) administered once or twice daily in Subjects with COPD The purpose of this study was to assess the total daily dose response of umeclidinium using pooled data from study AC4113073 and AC4115321 (excluding the site with Investigator ID of 040688) following once daily doses of umeclidinium (15.6, 31.25, 62.5, 125, 250, 500, and 1000mcg) and twice daily doses of umeclidinium (15.6, 31.25 62.5, 125, and 250mcg) compared with placebo in subjects with chronic obstructive pulmonary disease (COPD). Study AC4113073 was a multicentre, randomized, double-blind, double-dummy, placebo-controlled, three-way cross-over, incomplete block design study to evaluate the safety and efficacy of five doses of the long-acting muscarinic receptor antagonist umeclidinium (GSK573719) (62.5mcg, 125mcg, 250mcg, 500mcg, and 1000mcg) administered once-daily and three doses of umeclidinium (62.5mcg, 125mcg, and 250mcg) administered twice-daily compared with placebo over a 14 day treatment period in subjects with chronic obstructive pulmonary disease (COPD). Study AC4115321 was a multicenter, randomized, double-blind, placebo controlled, three way crossover, incomplete block study to evaluate the dose response of 4 doses of umeclidinium Inhalation Powder (15.6 mcg, 31.25 mcg, 62.5 mcg, and 125mcg) administered once daily over a 7 day treatment period in patients with COPD. Study AC4115321 also evaluated the safety and efficacy of the 4 doses of umeclidinium (15.6 mcg, 31.25 mcg, 62.5 mcg, and 125 mcg) administered once daily and 2 doses of umeclidinium (15.6 mcg and 31.25 mcg) administered twice daily compared with placebo over 7 days in subjects with COPD. An open label tiotropium (18mcg once-daily) group was included as an active control in both studies. This meta-analysis combined the two studies’ data together to evaluate the dose response of umeclidinium to better inform dose selection of umeclidinium.

  • Country None
  • organs None
  • Specialty None
Closed trial
gsk Update Il y a 5 ans
  • Country None
  • organs None
  • Specialty None
Closed trial
gsk Update Il y a 5 ans

PRJ2203: A Prospective Observational Cohort Study to Monitor Occurrence of Hypersensitivity Reaction and Hepatotoxicity in Patients Receiving Dolutegravir Dolutegravir (DTG) is recommended for both treatment-naïve and treatment-experienced, HIV infected adults and paediatric patients aged 12 years and older and weighing at least 40 kg. One case of suspected DTG hypersensitivity (HSR) reaction from among over 1500 patients exposed to the drug at the time of submission in 4Q2012, has been identified; this subject experienced a diffuse maculopapular rash with fever and elevated liver enzymes. Isolated rash was uncommon in the DTG programme with less than 1% of clinical trial patients experiencing treatment related rash. The pharmacovigilance strategy for DTG and DTG-containing products is to implement a post-marketing risk management program to further quantify the risk of HSR and compare it to that of other integrase inhibitors, and to possibly determine associated risk factors. In addition, the post-authorization safety study will monitor and compare hepatotoxicity and severe skin rash following initiation of DTG or other integrase inhibitor (raltegravir (RAL) or elvitegravir (EGV) based antiretroviral regimens. Further to be able to distinguish the above symptoms and reactions caused by DTG or the other integrase inhibitor regimen from that of abacavir (ABC), known to cause hypersensitivity reaction, the integrase inhibitor groups will be compared in combinations with and without ABC. This five year-long safety study will be conducted through collaboration with EuroSIDA, a well established prospective observational cohort study of more than 18,200 patients followed in 107 hospitals in 31 European countries, plus Israel and Argentina. This is a five year-long non-interventional prospective cohort study nested within the EuroSIDA study. The study population will include HIV positive patients over the age of 16 years from EuroSIDA clinical sites, who are new users of DTG or other integrase inhibitors with and without ABC. Following initiation of DTG with ABC based antiretroviral regimen or DTG without ABC or regimens containing other integrase inhibitors (RAL, EGV) with or without ABC, the study will aim to a) Monitor and compare hypersensitivity reaction, b) Monitor and compare hepatotoxicity, and c) Monitor and compare severe skin rash among all patients discontinuing DTG or other integrase inhibitor regimens for any reason.

  • Country None
  • organs None
  • Specialty None
Closed trial