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NCT03240575 · ClinicalTrials.gov registry record · Phase 4
The ENERGITO® 2 Study Compares 2 Inhaled Medicines for Chronic Obstructive Pulmonary Disease (COPD). One Medicine is a Combination of Tiotropium and Olodaterol (Stiolto®) Taken Using the Respimat® Inhaler and the Other Medicine is a Combination of Fluticasone and Salmeterol Taken Using the Diskus
A Phase 4 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 4
- Development phase
- 302
- Enrollment target
NCT03240575 is a Phase 4 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 302 participants.
The verdict
NCT03240575, a Phase 4 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 302 participants
- Enrollment target
Study Summary
The primary objective of the trial is to show superiority in lung function of once daily (2 inhalations) treatment with orally inhaled tiotropium+olodaterol fixed dose combination to twice daily (one inhalation) treatment with fluticasone propionate+salmeterol fixed dose combination over 12 weeks in patients with Chronic Obstructive Pulmonary Disease (COPD). A Digital Health (DH) exploratory study has been integrated into the main study as a site specific study. The DH exploratory study will be performed at a single site; the site is also participating in the main study. The DH exploratory study site will enter (randomize) approximately 20 patients (subjects) (in addition to the patients to be enrolled in the main study at this site). The patients enrolled in the DH exploratory study are not considered to be part of the main study (i.e. data collected in the DH exploratory study will be analyzed separately from the data collected in the main study).
Interventions
- DRUG Tiotropium
- DRUG Salmeterol
- DRUG Fluticasone propionate
- DRUG Olodaterol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 302 participants |
| Start Date | 2017-08-14 |
| Est. Completion | 2019-05-06 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03240575
The ClinicalTrials.gov registry entry for NCT03240575 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 302 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boehringer Ingelheim, which has 515 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Tiotropium is the first listed.
NCT03240575 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03240575 about?
NCT03240575 is a clinical study titled "The ENERGITO® 2 Study Compares 2 Inhaled Medicines for Chronic Obstructive Pulmonary Disease (COPD). One Medicine is a Combination of Tiotropium and Olodaterol (Stiolto®) Taken Using the Respimat® Inhaler and the Other Medicine is a Combination of Fluticasone and Salmeterol Taken Using the Diskus". The primary objective of the trial is to show superiority in lung function of once daily (2 inhalations) treatment with orally inhaled tiotropium+olodaterol fixed dose combination to twice daily (one inhalation) treatment with fluticasone propionate+salmeterol fixed dose combination over 12 weeks in...
What is the current status of trial NCT03240575?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 302 participants. The study started on 2017-08-14. Estimated completion is 2019-05-06.
What interventions are being tested in trial NCT03240575?
The interventions under investigation include: Tiotropium (DRUG), Salmeterol (DRUG), Fluticasone propionate (DRUG), Olodaterol (DRUG).
Who is sponsoring clinical trial NCT03240575?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
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