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NCT01712854 · ClinicalTrials.gov registry record · Phase 4
Effects of Symbicort on the Ventilatory Kinematics
A Phase 4 study, sponsored by Columbia University.
- Terminated
- Registry status
- Phase 4
- Development phase
- 9
- Enrollment target
NCT01712854 is a Phase 4 study that was terminated before completion, run by Columbia University. The registered enrollment target is 9 participants.
The verdict
NCT01712854, a Phase 4 study, was terminated before completion, sponsored by Columbia University.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 9 participants
- Enrollment target
Study Summary
The purpose of this study is to investigate how budesonide/formoterol fumarate dihydrate (Symbicort ©) affects dynamic hyperinflation in patients with obstructive disease using Optoelectronic Plethysmography (OEP). This study is unique as it will be the first randomized, doubleblind, crossover study with a placebo inhaler and budesonide/formoterol fumarate dihydrate as the intervention which will evaluate the effects on ventilatory mechanics through the use of OEP. The investigators plan to demonstrate that budesonide/formoterol fumarate dihydrate impacts dynamic hyperinflation which can be detected with OEP, and that budesonide/formoterol fumarate dihydrate may have an effect in the short term on exercise capacity during a constant load exercise test. The changes in ventilatory mechanics measured after budesonide/formoterol fumarate dihydrate by OEP will provide a unique evaluation of budesonide/formoterol fumarate dihydrate in a controlled setting also demonstrating the utility of OEP in evaluating of the effects of a medical treatment on hyperinflation in individuals with chronic obstructive lung disease (COPD). 1. Primary Objective/Hypothesis: Our objective is to measure baseline, post treatment and post exercise spirometry and evaluate exercise dynamic hyperinflation before and after treatment using OEP. The investigators hypothesize that budesonide/formoterol fumarate dihydrate will decrease dynamic hyperinflation as measured by OEP. 2. Primary Endpoint: Our primary endpoint is the change in dynamic hyperinflation, specifically end expiratory volumes, dynamic lung volumes and diaphragmatic paradoxical breathing as measured by OEP. 3. Secondary Objective: Our secondary objective is to evaluate duration of steady state exercise and exercise capacity before and after treatment. Our secondary hypothesis is that decreases in dynamic hyperinflation during exercise will lead to improvements in dyspnea with exercise, and allow for increases in exercise capacity. 4. S
Interventions
- DRUG Budesonide
- DRUG Symbicort
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2012-03 |
| Est. Completion | 2012-09 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01712854
The ClinicalTrials.gov registry entry for NCT01712854 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 9 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Columbia University, which has 958 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Budesonide is the first listed.
NCT01712854 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01712854 about?
NCT01712854 is a clinical study titled "Effects of Symbicort on the Ventilatory Kinematics". The purpose of this study is to investigate how budesonide/formoterol fumarate dihydrate (Symbicort ©) affects dynamic hyperinflation in patients with obstructive disease using Optoelectronic Plethysmography (OEP). This study is unique as it will be the first randomized, doubleblind, crossover study...
What is the current status of trial NCT01712854?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 9 participants. The study started on 2012-03. Estimated completion is 2012-09.
What interventions are being tested in trial NCT01712854?
The interventions under investigation include: Budesonide (DRUG), Symbicort (DRUG).
Who is sponsoring clinical trial NCT01712854?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
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