NCT01641692 - A 3-period Crossover Study With GSK573719 as Monotherapy in Adult Subjects With Asthma | Biotech Hunter

Enrollment

350

Participants

Timeline

Start Date

May 31, 2012

Primary Completion Date

February 28, 2013

Study Completion Date

February 28, 2013

Conditions

Asthma

Interventions

DRUG

GSK573719 Active treatment or Placebo

Eligible subjects will be randomised to a sequence of three treatments from 8 possible arms: 7 active drug doses (15.6mcg, 31.25 mc, 62.5mcg 125mcg or 250mcg GSK573719 once daily; 15.6mcg or 31.25 mcg GSK573719 taken twice daily) or matched placebo.

PROCEDURE

GSK573719 (Sub-group cohort)

Subjects at selected Sub-group sites (approximately 30% of the total population) will have additional serial assessments and procedures (including blood and urine samples for pharmacokinetic analysis) at the start (Day 1) and at the end (Days 14 and 15) of each treatment period. On Day 14 of each treatment period subjects will remain overnight at the clinic for 24-hour assessments, including spirometry, ECGs, and 24-hour Holter monitoring.

DRUG

Salbutamol/Albuterol

Salbutamol/Albuterol, short-activing beta agonist provided to all subjects to be taken as needed for the relief of asthma symptoms.throughout the study period, including washout periods

Trial Locations (43)

1431

GSK Investigational Site, Sofia

4003

GSK Investigational Site, Plovdiv

5500

GSK Investigational Site, Lovech

5800

GSK Investigational Site, Pleven

6000

GSK Investigational Site, Stara Zagora

7000

GSK Investigational Site, Rousse

9000

GSK Investigational Site, Varna

10717

GSK Investigational Site, Berlin

10787

GSK Investigational Site, Berlin

10789

GSK Investigational Site, Berlin

12203

GSK Investigational Site, Berlin

20814

GSK Investigational Site, Bethesda

21502

GSK Investigational Site, Geesthacht

22299

GSK Investigational Site, Hamburg

22767

GSK Investigational Site, Hamburg

29118

GSK Investigational Site, Orangeburg

29303

GSK Investigational Site, Spartanburg

44100

GSK Investigational Site, Guadalajara

45040

GSK Investigational Site, Zapopan

60596

GSK Investigational Site, Frankfurt am Main

63141

GSK Investigational Site, St Louis

63263

GSK Investigational Site, Neu-Isenburg

65203

GSK Investigational Site, Columbia

65401

GSK Investigational Site, Rolla

69469

GSK Investigational Site, Weinheim

70584

GSK Investigational Site, Sunset

78229

GSK Investigational Site, San Antonio

78750

GSK Investigational Site, Austin

92663

GSK Investigational Site, Newport Beach

97504

GSK Investigational Site, Medford

68123-4303

GSK Investigational Site, Bellevue

Lima 18

GSK Investigational Site, Lima

Lima 1

GSK Investigational Site, Lima

Lima 27

GSK Investigational Site, Lima

Lima 41

GSK Investigational Site, San Borja

Lima 32

GSK Investigational Site, San Miguel

Lima 33

GSK Investigational Site, Santiago de Surco

15-010

GSK Investigational Site, Bialystok

31-024

GSK Investigational Site, Krakow

31-455

GSK Investigational Site, Krakow

41-790

GSK Investigational Site, Ruda Śląska

47-120

GSK Investigational Site, Zawadzkie

95-100

GSK Investigational Site, Zgierz