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NCT02085161 · ClinicalTrials.gov registry record · Phase 3
To Evaluate the Effect of Inhaled Medication Together With Exercise and Activity Training on Exercise Capacity and Daily Activities in Patients With Chronic Lung Disease With Obstruction of Airways
A Phase 3 study of Pulmonary Disease, Chronic Obstructive, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 3
- Development phase
- 304
- Enrollment target
- 20
- Study locations
NCT02085161: Completed Phase 3 study of Pulmonary Disease, Chronic Obstructive, sponsored by Boehringer Ingelheim.
NCT02085161 is a Phase 3 study of Pulmonary Disease, Chronic Obstructive that has completed, run by Boehringer Ingelheim. The registered enrollment target is 304 participants, below the 1,040-participant average among 74 other Pulmonary Disease, Chronic Obstructive trials with a reported enrollment target (71% lower). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02085161, a Phase 3 study of Pulmonary Disease, Chronic Obstructive, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 304 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary objectives of the study are to explore the effect of treatment with orally inhaled tiotropium + olodaterol fixed dose combination with and without exercise training, and tiotropium comparing to placebo, on top of behavioural modification in improving exercise capacity in patients with COPD
Primary Outcome
Endurance time during ESWT to symptom limitation at walking speed corresponding to 85% of predicted maximum oxygen consumption (VO2 peak) after 8 weeks of pharmacological treatment and non-pharmacological intervention. The numerical value of endurance time in seconds was transformed in log10 scale to correct for skewness and then an analysis of covariance (ANCOVA) was fitted to the log10-transformed data and the least square means (LSMean) and standard error (SE) were obtained. To present the re
Conditions Studied
Interventions
- DRUG tiotropium
- DRUG placebo to tiotropium + olodaterol
- DRUG tiotropium+olodaterol
- DRUG tiotropium +olodaterol
Study Locations (20)
Other
- Boehringer Ingelheim Investigational Site - Salzburg
- Boehringer Ingelheim Investigational Site - Genk
- Boehringer Ingelheim Investigational Site - Hasselt
- Boehringer Ingelheim Investigational Site - Leuven
- Boehringer Ingelheim Investigational Site - Kolding
- Boehringer Ingelheim Investigational Site - København NV
- Boehringer Ingelheim Investigational Site - Odense
- Boehringer Ingelheim Investigational Site - Berlin
- Boehringer Ingelheim Investigational Site - Bochum
- Boehringer Ingelheim Investigational Site - Frankfurt
- Boehringer Ingelheim Investigational Site - Großhansdorf
- Boehringer Ingelheim Investigational Site - Heidelberg
California
- Boehringer Ingelheim Investigational Site - San Diego
- Boehringer Ingelheim Investigational Site - Torrance
South Australia
- Boehringer Ingelheim Investigational Site - Daw Park
- Boehringer Ingelheim Investigational Site - Glen Osmond
Quebec
- Boehringer Ingelheim Investigational Site - Montreal
- Boehringer Ingelheim Investigational Site - Ste-Foy
Connecticut
- Boehringer Ingelheim Investigational Site - Hartford
Saskatchewan
- Boehringer Ingelheim Investigational Site - Saskatoon
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 304 participants |
| Start Date | 2014-03 |
| Est. Completion | 2015-10 |
| Phase | Phase 3 |
What the finished NCT02085161 record still lists
NCT02085161 is an interventional study that assigns participants to a tested intervention. The registered 304 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 (71% lower).
The record links to 1 condition, with Pulmonary Disease, Chronic Obstructive appearing as the primary indexed condition, and to 4 interventions - of which tiotropium is the first listed.
NCT02085161 names 20 study sites across 6 states, led by Other, California, South Australia.
Frequently Asked Questions
What is clinical trial NCT02085161 about?
NCT02085161 is a clinical study titled "To Evaluate the Effect of Inhaled Medication Together With Exercise and Activity Training on Exercise Capacity and Daily Activities in Patients With Chronic Lung Disease With Obstruction of Airways". The primary objectives of the study are to explore the effect of treatment with orally inhaled tiotropium + olodaterol fixed dose combination with and without exercise training, and tiotropium comparing to placebo, on top of behavioural modification in improving exercise capacity in patients with CO...
What is the current status of trial NCT02085161?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 304 participants. The study started on 2014-03. Estimated completion is 2015-10.
What conditions does trial NCT02085161 study?
This clinical trial studies the following conditions: Pulmonary Disease, Chronic Obstructive.
What interventions are being tested in trial NCT02085161?
The interventions under investigation include: tiotropium (DRUG), placebo to tiotropium + olodaterol (DRUG), tiotropium+olodaterol (DRUG), tiotropium +olodaterol (DRUG).
Who is sponsoring clinical trial NCT02085161?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02085161 being conducted?
This trial has 20 study locations across California, Connecticut, South Australia, Quebec, Saskatchewan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02085161's enrollment target sits among peer trials
304 36th of 74 higher than 39 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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