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NCT03084718 · ClinicalTrials.gov registry record · Phase 2
An 8-week Dose Ranging Study of CHF 718 pMDI in Asthmatic Subjects
A Phase 2 study, sponsored by Chiesi Farmaceutici S.p.A..
- Completed
- Registry status
- Phase 2
- Development phase
- 610
- Enrollment target
NCT03084718: Completed Phase 2 study, sponsored by Chiesi Farmaceutici S.p.A..
NCT03084718 is a Phase 2 study that has completed, run by Chiesi Farmaceutici S.p.A.. The registered enrollment target is 610 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (359% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03084718, a Phase 2 study, has completed, sponsored by Chiesi Farmaceutici S.p.A..
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 610 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the dose-response of different doses of CHF 781 Pressurized Metered Dose Inhaler (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 patient population.
Primary Outcome
Change from baseline in pre-dose morning FEV1 (average of pre-dose FEV1 measurements) at Week 8. Spirometry, used to measure FEV1, was performed according to internationally accepted standards. Definitions: Baseline=Baseline values for pre-dose FEV1 were the average of measurements taken at V2 (Week 0) at 45 minutes and 15 minutes pre-dose; FEV1=Forced expiratory volume in the 1st second;
Interventions
- DRUG Placebo pMDI
- DRUG CHF 718 pMDI
- DRUG Beclomethasone Dipropionate (BDP)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 610 participants |
| Start Date | 2017-07-28 |
| Est. Completion | 2018-12-05 |
| Phase | Phase 2 |
What the finished NCT03084718 record still lists
NCT03084718 is an interventional study that assigns participants to a tested intervention. The registered 610 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 (359% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo pMDI is the first listed.
NCT03084718 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03084718 about?
NCT03084718 is a clinical study titled "An 8-week Dose Ranging Study of CHF 718 pMDI in Asthmatic Subjects". The purpose of this study is to evaluate the dose-response of different doses of CHF 781 Pressurized Metered Dose Inhaler (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 patient population.
What is the current status of trial NCT03084718?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 610 participants. The study started on 2017-07-28. Estimated completion is 2018-12-05.
What interventions are being tested in trial NCT03084718?
The interventions under investigation include: Placebo pMDI (DRUG), CHF 718 pMDI (DRUG), Beclomethasone Dipropionate (BDP) (DRUG).
Who is sponsoring clinical trial NCT03084718?
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 NCT03084718's enrollment target sits among peer trials
610 53rd of 2000 higher than 1,948 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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