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NCT03084796 · ClinicalTrials.gov registry record · Phase 2
A 6-week Dose Ranging Study of CHF 5259 pMDI in Subjects With Chronic Obstructive Pulmonary Disease
A Phase 2 study, sponsored by Chiesi Farmaceutici S.p.A..
- Completed
- Registry status
- Phase 2
- Development phase
- 733
- Enrollment target
NCT03084796: Completed Phase 2 study, sponsored by Chiesi Farmaceutici S.p.A..
NCT03084796 is a Phase 2 study that has completed, run by Chiesi Farmaceutici S.p.A.. The registered enrollment target is 733 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (451% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03084796, a Phase 2 study, has completed, sponsored by Chiesi Farmaceutici S.p.A..
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 733 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the dose-response of different doses of CHF 5259 pMDI on lung function and other clinical outcomes, to identify the optimal dose(s) in terms of benefit/ risk ratio for further development in the target subject population.
Primary Outcome
Change from baseline in FEV1 AUC(0-12h), normalized by time, at the end of treatment (Week 6). Spirometry, used to measure FEV1, was performed according to internationally accepted standards. The AUC for FEV1 at Week 6 of treatment was calculated by using the linear trapezoidal rule, based on the changes in FEV1 from the baseline values, and divided by the observation time (12 hours). Definitions: AUC=Area under the curve; Baseline=Baseline value was the average of the pre-dose measurements (
Interventions
- DRUG Placebo
- DRUG CHF 5259
- DRUG Tiotropium Bromide 18 µg Inhalation Capsule
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 733 participants |
| Start Date | 2017-07-28 |
| Est. Completion | 2018-06-06 |
| Phase | Phase 2 |
What the finished NCT03084796 record still lists
NCT03084796 is an interventional study that assigns participants to a tested intervention. The registered 733 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (451% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03084796 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03084796 about?
NCT03084796 is a clinical study titled "A 6-week Dose Ranging Study of CHF 5259 pMDI in Subjects With Chronic Obstructive Pulmonary Disease". The purpose of this study is to evaluate the dose-response of different doses of CHF 5259 pMDI on lung function and other clinical outcomes, to identify the optimal dose(s) in terms of benefit/ risk ratio for further development in the target subject population.
What is the current status of trial NCT03084796?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 733 participants. The study started on 2017-07-28. Estimated completion is 2018-06-06.
What interventions are being tested in trial NCT03084796?
The interventions under investigation include: Placebo (DRUG), CHF 5259 (DRUG), Tiotropium Bromide 18 µg Inhalation Capsule (DRUG).
Who is sponsoring clinical trial NCT03084796?
This trial is sponsored by Chiesi Farmaceutici S.p.A., which has 30 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03084796's enrollment target sits among peer trials
733 45th of 2000 higher than 1,956 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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