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NCT02207829 · ClinicalTrials.gov registry record · Phase 3

A 12-week Study to Evaluate the Efficacy and Safety of Umeclidinium Compared With Tiotropium in Subjects With Chronic Obstructive Pulmonary Disease

A Phase 3 study of Pulmonary Disease, Chronic Obstructive, sponsored by GlaxoSmithKline.

Completed
Registry status
Phase 3
Development phase
1,017
Enrollment target
20
Study locations

NCT02207829 is a Phase 3 study of Pulmonary Disease, Chronic Obstructive that has completed, run by GlaxoSmithKline. The registered enrollment target is 1,017 participants, roughly in line with the 1,030-participant average among 74 other Pulmonary Disease, Chronic Obstructive trials with a reported enrollment target. The trial reports 20 study locations across 9 states.

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The verdict

NCT02207829, a Phase 3 study of Pulmonary Disease, Chronic Obstructive, has completed, sponsored by GlaxoSmithKline.

COMPLETED
Registry status
Phase 3
Development phase
1,017 participants
Enrollment target
20
Study locations

Study Summary

This is a multicentre, randomized, blinded, double dummy, parallel group study to evaluate the efficacy and safety of UMEC inhalation powder\[ (62.5 microgram (mcg) once daily (QD)\] when administered via a novel Dry Powder Inhaler compared with tiotropium (18 mcg QD) administered via a HANDIHALER® inhaler over a treatment period of 12 weeks (24 weeks in Germany) in subjects with chronic obstructive pulmonary disease (COPD). At the end of the run-in period, subjects who meet the randomization criteria will be randomized to receive UMEC 62.5 mcg administered via novel dry powder inhaler(nDPI) + Placebo administered via HANDIHALER inhaler OR Tiotropium 18 mcg administered via HANDIHALER inhaler + Placebo administered via nDPI in a 1:1 ratio. There will be up to 8 clinic visits conducted on an outpatient basis at Pre-Screening (Visit 0), Screening (Visit 1), a 7 to 14 day run-in period, randomization at Day 1 (Visit 2), and after randomization at Day 2 (Visit 3), Day 28 (Visit 4), Day 56 (Visit 5), Day 84 (Visit 6) and Day 85 (Visit 7). For subjects enrolled in Germany, there will be an additional 3 visits at Day 112 (Visit 8), Day 140 (Visit 9) and Day 168 (Visit 10). The total duration of subject participation in the study will be approximately 15 weeks (27 weeks in Germany). The primary endpoint of the study is clinic visit trough forced expiratory volume in one second (FEV1) on treatment Day 85. All subjects will have spirometry performed at clinic Visits 1 though 7. Trough spirometry will be obtained 23 and 24 hours after the previous day's dose of blinded study medication at Visits 3 to 7. HANDIHALER is a registered trademark of Boehringer Ingelheim Pharma GmbH \& Co. KG.

Conditions Studied

Pulmonary Disease, Chronic Obstructive

Interventions

  • DRUG Umeclidinium
  • DRUG Umeclidinium matching placebo
  • DRUG Tiotropium
  • DRUG Tiotropium matching placebo

Study Locations (20)

Quebec

  • GSK Investigational Site - Montreal
  • GSK Investigational Site - Québec
  • GSK Investigational Site - Québec
  • GSK Investigational Site - Saint-Charles-Borromée
  • GSK Investigational Site - Sherbrooke

Other

  • GSK Investigational Site - Buenos Aires
  • GSK Investigational Site - Buenos Aires
  • GSK Investigational Site - Talcahuano
  • GSK Investigational Site - Aarhus C

Ontario

  • GSK Investigational Site - Greater Sudbury
  • GSK Investigational Site - Toronto
  • GSK Investigational Site - Toronto

Región Metro de Santiago

  • GSK Investigational Site - Santiago
  • GSK Investigational Site - Santiago
  • GSK Investigational Site - Santiago

South Carolina

  • GSK Investigational Site - Spartanburg

Manitoba

  • GSK Investigational Site - Winnipeg

Newfoundland and Labrador

  • GSK Investigational Site - St. John's

Nova Scotia

  • GSK Investigational Site - Truro

Trial Details

FieldValue
Enrollment Target 1,017 participants
Start Date 2014-09-01
Est. Completion 2015-06-15
Phase Phase 3

Sponsor

GlaxoSmithKline

1,345 total trials

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What the Registry Record Tells You About NCT02207829

The ClinicalTrials.gov registry entry for NCT02207829 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,017 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 1,030-participant average among 74 other Pulmonary Disease, Chronic Obstructive trials with a reported enrollment target. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Pulmonary Disease, Chronic Obstructive appearing as the primary indexed condition, and to 4 interventions - of which Umeclidinium is the first listed.

NCT02207829 reports 20 study locations spanning 9 distinct geographic areas - top geographies include Quebec, Other, Ontario.

Frequently Asked Questions

What is clinical trial NCT02207829 about?

NCT02207829 is a clinical study titled "A 12-week Study to Evaluate the Efficacy and Safety of Umeclidinium Compared With Tiotropium in Subjects With Chronic Obstructive Pulmonary Disease". This is a multicentre, randomized, blinded, double dummy, parallel group study to evaluate the efficacy and safety of UMEC inhalation powder\[ (62.5 microgram (mcg) once daily (QD)\] when administered via a novel Dry Powder Inhaler compared with tiotropium (18 mcg QD) administered via a HANDIHALER® ...

What is the current status of trial NCT02207829?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,017 participants. The study started on 2014-09-01. Estimated completion is 2015-06-15.

What conditions does trial NCT02207829 study?

This clinical trial studies the following conditions: Pulmonary Disease, Chronic Obstructive.

What interventions are being tested in trial NCT02207829?

The interventions under investigation include: Umeclidinium (DRUG), Umeclidinium matching placebo (DRUG), Tiotropium (DRUG), Tiotropium matching placebo (DRUG).

Who is sponsoring clinical trial NCT02207829?

This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02207829 being conducted?

This trial has 20 study locations across South Carolina, Manitoba, Newfoundland and Labrador, Nova Scotia, Ontario. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.