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NCT01533922 · ClinicalTrials.gov registry record · Phase 3
Effect on Exercise Endurance and Lung Hyperinflation of Tiotropium + Olodaterol in COPD Patients
A Phase 3 study of Pulmonary Disease, Chronic Obstructive, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 3
- Development phase
- 295
- Enrollment target
- 20
- Study locations
NCT01533922: Completed Phase 3 study of Pulmonary Disease, Chronic Obstructive, sponsored by Boehringer Ingelheim.
NCT01533922 is a Phase 3 study of Pulmonary Disease, Chronic Obstructive that has completed, run by Boehringer Ingelheim. The registered enrollment target is 295 participants, below the 1,040-participant average among 74 other Pulmonary Disease, Chronic Obstructive trials with a reported enrollment target (72% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01533922, a Phase 3 study of Pulmonary Disease, Chronic Obstructive, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 295 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary objective of this trial is to investigate the effect of 6 weeks treatment with tiotropium + olodaterol fixed dose combination inhalation solution on lung hyperinflation and exercise tolerance in patients with COPD
Primary Outcome
Inspiratory capacity (IC) at rest before constant work rate cycle ergometry to symptom limitation at 75% maximal work capacity (Wcap). Wcap was defined as the maximum work rate achieved for at least 30 seconds during the incremental cycle ergometry performed at Visit 1. The presented means are adjusted means from the MMRM (Mixed Effects Model Repeated Measures) model.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Tiotropium
- DRUG tiotropium + olodaterol
- DRUG Olodaterol
- DRUG Tiotropium + Olodaterol
Study Locations (20)
Other
- 1237.13.54301 Boehringer Ingelheim Investigational Site - Capital Federal
- 1237.13.54302 Boehringer Ingelheim Investigational Site - Mar del Plata
- 1237.13.43303 Boehringer Ingelheim Investigational Site - Linz
- 1237.13.43301 Boehringer Ingelheim Investigational Site - Thalheim bei Wels
- 1237.13.32302 Boehringer Ingelheim Investigational Site - Brussels
- 1237.13.32303 Boehringer Ingelheim Investigational Site - Edegem
- 1237.13.32305 Boehringer Ingelheim Investigational Site - Jambes
South Carolina
- 1237.13.01305 Boehringer Ingelheim Investigational Site - Easley
- 1237.13.01301 Boehringer Ingelheim Investigational Site - Greenville
- 1237.13.01303 Boehringer Ingelheim Investigational Site - Spartanburg
South Australia
- 1237.13.61301 Boehringer Ingelheim Investigational Site - Daw Park
- 1237.13.61305 Boehringer Ingelheim Investigational Site - Toorak Gardens
Victoria
- 1237.13.61304 Boehringer Ingelheim Investigational Site - Footscray
- 1237.13.61302 Boehringer Ingelheim Investigational Site - Prahran
California
- 1237.13.01302 Boehringer Ingelheim Investigational Site - Torrance
Connecticut
- 1237.13.01308 Boehringer Ingelheim Investigational Site - Hartford
Michigan
- 1237.13.01304 Boehringer Ingelheim Investigational Site - Livonia
Pennsylvania
- 1237.13.01307 Boehringer Ingelheim Investigational Site - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 295 participants |
| Start Date | 2012-03 |
| Est. Completion | 2013-11 |
| Phase | Phase 3 |
What the finished NCT01533922 record still lists
NCT01533922 is an interventional study that assigns participants to a tested intervention. The registered 295 participants enrollment target is mid-sized for trials with a published cap, below the 1,040-participant average among 74 other Pulmonary Disease, Chronic Obstructive trials with a reported enrollment target (72% lower).
The record links to 1 condition, with Pulmonary Disease, Chronic Obstructive appearing as the primary indexed condition, and to 5 interventions - of which Placebo is the first listed.
NCT01533922 names 20 study sites across 10 states, led by Other, South Carolina, South Australia.
Frequently Asked Questions
What is clinical trial NCT01533922 about?
NCT01533922 is a clinical study titled "Effect on Exercise Endurance and Lung Hyperinflation of Tiotropium + Olodaterol in COPD Patients". The primary objective of this trial is to investigate the effect of 6 weeks treatment with tiotropium + olodaterol fixed dose combination inhalation solution on lung hyperinflation and exercise tolerance in patients with COPD
What is the current status of trial NCT01533922?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 295 participants. The study started on 2012-03. Estimated completion is 2013-11.
What conditions does trial NCT01533922 study?
This clinical trial studies the following conditions: Pulmonary Disease, Chronic Obstructive.
What interventions are being tested in trial NCT01533922?
The interventions under investigation include: Placebo (DRUG), Tiotropium (DRUG), tiotropium + olodaterol (DRUG), Olodaterol (DRUG), Tiotropium + Olodaterol (DRUG).
Who is sponsoring clinical trial NCT01533922?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01533922 being conducted?
This trial has 20 study locations across California, Connecticut, Michigan, Pennsylvania, South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01533922's enrollment target sits among peer trials
295 38th of 74 higher than 37 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.
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