Completed

Study Description:

The primary objective is to compare the efficacy of UMEC/VI Inhalation Powder (62.5/25 mcg) once-daily with tiotropium (18 mcg) once-daily over 12 weeks for the treatment of subjects with COPD who have received tiotropium and continue to have symptoms while on tiotropium.

GSK Study ID:

116960


Has Results Document Available
ClinicalTrials.gov Identifier:

NCT01899742


Has Results Available Below
EudraCT Number:

2012-005007-41


Study Overview

Medical Conditions

Chronic Obstructive Pulmonary Disease

Product

tiotropium bromide;umeclidinium bromide;umeclidinium bromide/vilanterol;vilanterol

Collaborators

N/A


Date

September 2014 to July 2015

Type

Interventional

Phase

3


Gender

All

Age

40 years - N/A

Accepts Healthy Volunteers

No


This study has Protocol and Result summary on ClinicalTrial.gov. Click here to learn more.

Locations

  • Central Contact :

    US GSK Clinical Trials Call Center

  • Central Contact Phone:

    877-379-3718

  • Central Contact Email:

    [email protected]

Argentina, Buenos Aires C1425BENCompleted
Argentina, Ciudad Autónoma de Buenos Aires C1426ABPCompleted
Argentina, San Miguel de Tucumán 4000Completed
Argentina, Buenos Aires, La Plata 1900Completed
Argentina, Mendoza, Mendoza M5500CCGCompleted
Argentina, Mendoza, Mendoza 5500Completed
Argentina, Mendoza, San Rafael 5600Completed
Estonia, Tallinn 13419Completed
Estonia, Tallinn 10138Completed
Estonia, Tallinn 10117Completed
Estonia, Tallinn 13619Completed
Estonia, Tartu 51014Completed
Germany, Berlin, Berlin 12157Completed
Germany, Berlin, Berlin 10367Completed
Germany, Berlin, Berlin 13581Completed
Germany, Berlin, Berlin 13086Completed
Germany, Brandenburg, Potsdam 14467Completed
Germany, Brandenburg, Potsdam 14469Completed
Germany, Hessen, Frankfurt 60596Completed
Germany, Hessen, Frankfurt 60389Completed
Germany, Niedersachsen, Hannover 30173Completed
Germany, Niedersachsen, Hannover 30159Completed
Germany, Nordrhein-Westfalen, Dortmund 44263Completed
Germany, Nordrhein-Westfalen, Dueren 52349Completed
Germany, Nordrhein-Westfalen, Witten 58452Completed
Norway, Bodø 8005Completed
Norway, Hamar 2317Completed
Norway, Haugesund 5528Completed
Norway, Kløfta 2040Completed
Norway, Stavanger 4005Completed
Norway, Tønsberg 3116Completed
Russia, Blagoveshchensk 675000Completed
Russia, Chelyabinsk 454021Completed
Russia, Irkutsk 664005Completed
Russia, Kemerovo 650000Completed
Russia, Kemerovo 650002Completed
Russia, Moscow 125315Completed
Russia, Novosibirsk 630102Completed
Russia, Saint-Petersburg 194356Completed
South Africa, Bellville 7530Completed
South Africa, Bloemfontein 9301Completed
South Africa, Durban 4001Completed
South Africa, Gatesville 7764Completed
South Africa, Middelburg 1501Completed
South Africa, Mowbray 7700Completed
South Africa, Somerset West 7130Completed
South Korea, Gyeonggi-do 410-719Completed
Sweden, BORÅS SE-506 30Completed
Sweden, GÖTEBORG SE-413 90Completed
Sweden, LULEÅ SE-971 89Completed
Sweden, LUND SE-221 85Completed
Sweden, STOCKHOLM SE-111 57Completed
Sweden, ÖREBRO SE-703 62Completed
Ukraine, Kharkiv 61124Completed
Ukraine, Kiev 03680Completed
Ukraine, Kyiv Completed
Ukraine, Kyiv 03038Completed
Ukraine, Kyiv 03049Completed
Ukraine, Kyiv 03680Completed
Ukraine, Mykolayiv 54003Completed
Ukraine, Vinnytsya 21001Completed
United States, Oregon, Medford 97504Completed
United States, South Carolina, Greenville 29615Completed
United States, South Carolina, Spartanburg 29303Completed

Study Design

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Study Design: Parallel Assignment
  • Study Classification: Not Available
  • Masking: Not Available
  • Masked Subject: Yes
  • Masked Caregiver: No
  • Masked Investigator: Yes
  • Masked Assessor: No
Primary Outcomes:

  • Change from Baseline in trough forced expiratory volume in one second (FEV1) on Day 85 (Visit 8)
    Timeframe: Baseline (BL) and Day 85

Secondary Outcomes:

  • Change from BL in FEV1 at 3 hours postdose on Day 84
    Timeframe: Baseline and Day 84

Arms:
  • 2

Interventions:

  • Drug: Umeclidinium/Vilanterol 62.5/25 mcg
  • Drug: Tiotropium 18 mcg
Inclusion / Exclusion Criteria: Click to view inclusion/exclusion criteria:
Enrollment: 497

Clinical Publications:

  • Kerwin EM Kalberg CJ, Galkin DV, Zhu C, Church A, Riley JH, Fahy WA. Umeclidinium/vilanterol as step-up therapy from tiotropium in patients with chronic obstructive pulmonary disease: a randomized, parallel group, 12-week study. Int J Chron Obstruct Pulmon Dis. 2017;12:745-755.