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A 12-week Study to Evaluate the Efficacy and Safety of Umeclidinium Compared With Tiotropium in Subjects With Chronic Obstructive Pulmonary Disease
NCT02207829 · View on ClinicalTrials.gov ↗
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02207829
The ClinicalTrials.gov registry entry for NCT02207829 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,017 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 558 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02207829 reports 20 study locations spanning 9 distinct geographic areas — top geographies include Quebec, Other, Ontario. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02207829?
This trial is sponsored by GlaxoSmithKline, which has 558 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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