Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 3 study of Pulmonary Disease, Chronic Obstructive, sponsored by GlaxoSmithKline.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 on Day 85 is defined as the mean of the FEV1 values obtained 23 and 24 hours after dosing on Day 84 (Week 12). Trough FEV1 measurements were taken electronically by spirometry on Days 2, 28, 56, 84 and 85. Baseline trough FEV1 is the mean of the two assessments made -30 and -5 minutes (min) pre-dose on Day 1. Change from baseline was calculated as the trough FE
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 1,017 participants |
| Start Date | 2014-09-01 |
| Est. Completion | 2015-06-15 |
| Phase | Phase 3 |
What the finished NCT02207829 record still lists
NCT02207829 is an interventional study that assigns participants to a tested intervention. Its 1,017 participants enrollment target places it among the larger protocols in the corpus, roughly in line with the 1,030-participant average among 74 other Pulmonary Disease, Chronic Obstructive trials with a reported enrollment target.
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 names 20 study sites across 9 states, led by 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.
Learn More About Clinical Trials
Similar trials for Pulmonary Disease, Chronic Obstructive
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02207829's enrollment target sits among peer trials
1,017 13th of 74 higher than 62 of 74 other Pulmonary Disease, Chronic Obstructive trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pulmonary Disease, Chronic Obstructive trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Depemokimab as an Extended treatmeNt Duration Biologic in Adults With Chronic Obstructive Pulmonary Disease (COPD) and Type 2 Inflammation (ENDURA-2)
RECRUITING · Phase 3
-
eValuating the Efficacy and Safety of InitiatinG depemokImab earLy therApy iN Chronic Obstructive Pulmonary Disorder (COPD) With Type 2 Inflammation
RECRUITING · Phase 3
-
Trial to Determine Effective Aspirin Dose in COPD
RECRUITING · Phase 3
-
Depemokimab as an Extended treatmeNt Duration Biologic in Adults With Chronic Obstructive Pulmonary Disease (COPD) and Type 2 Inflammation (ENDURA -1)
RECRUITING · Phase 3
-
An Exercise Endurance Study to Evaluate the Effects of Treatment of Chronic Obstructive Pulmonary Disease (COPD) Patients With a Dual Bronchodilator: GSK573719/GW642444.Study B
COMPLETED · Phase 3
-
Tiotropium / Respimat One-Year Study
COMPLETED · Phase 3
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT06549595 · 1,018 participants · Phase 3
A Study of Surovatamig (AZD0486) Plus Rituximab in Previously Untreated Follicular Lymphoma Patients
- NCT06608823 · 1,016 participants · NA
ARTIST: Aortic Regurgitation Trial Investigating Surgery Versus Trilogy™
- NCT06146738 · 1,015 participants
The PALSUR-study: Palliative Care Versus Surgery in High-grade Glioma Patients (ENCRAM 2203)
- NCT02178163 · 1,020 participants · NA
Comprehensive Genomic Analysis in Tissue Samples From Patients With Recurrent or Stage IV Non-small Cell Lung Cancer
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI