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NCT03086460 · ClinicalTrials.gov registry record · Phase 2
A Dose Ranging Study With CHF 1531 in Subjects With Asthma (FLASH)
A Phase 2 study, sponsored by Chiesi Farmaceutici S.p.A..
- Completed
- Registry status
- Phase 2
- Development phase
- 67
- Enrollment target
NCT03086460: Completed Phase 2 study, sponsored by Chiesi Farmaceutici S.p.A..
NCT03086460 is a Phase 2 study that has completed, run by Chiesi Farmaceutici S.p.A.. The registered enrollment target is 67 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03086460, a Phase 2 study, has completed, sponsored by Chiesi Farmaceutici S.p.A..
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 67 participants
- Enrollment target
Study Summary
To evaluate the dose-response of different doses of CHF 1531 pressurized metered dose inhaler (pMDI) containing formoterol fumarate, on lung function and other clinical outcomes and to identify the optimal dose(s) with regard to benefit/ risk ratio for further development in the target subject population.
Primary Outcome
Spirometry used to measure FEV1, was performed according to internationally accepted standards. Results show the change from baseline in FEV1 AUC(0-12h), normalized by time on Day 14; it was calculated by using the linear trapezoidal rule, based on the changes in FEV1 from the baseline values. Patients receiving the same treatment during two periods are considered twice in the ANCOVA model (once for each period attended). Definitions: AUC=Area under the curve; AUC(0-12h)=AUC between 0 and 12
Interventions
- DRUG Placebo pMDI
- DRUG CHF 1531 pMDI
- DRUG Formoterol Inhalation Solution
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 67 participants |
| Start Date | 2017-09-08 |
| Est. Completion | 2018-07-28 |
| Phase | Phase 2 |
What the finished NCT03086460 record still lists
NCT03086460 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 67 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo pMDI is the first listed.
NCT03086460 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03086460 about?
NCT03086460 is a clinical study titled "A Dose Ranging Study With CHF 1531 in Subjects With Asthma (FLASH)". To evaluate the dose-response of different doses of CHF 1531 pressurized metered dose inhaler (pMDI) containing formoterol fumarate, on lung function and other clinical outcomes and to identify the optimal dose(s) with regard to benefit/ risk ratio for further development in the target subject popul...
What is the current status of trial NCT03086460?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 67 participants. The study started on 2017-09-08. Estimated completion is 2018-07-28.
What interventions are being tested in trial NCT03086460?
The interventions under investigation include: Placebo pMDI (DRUG), CHF 1531 pMDI (DRUG), Formoterol Inhalation Solution (DRUG).
Who is sponsoring clinical trial NCT03086460?
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 NCT03086460's enrollment target sits among peer trials
67 974th of 2000 higher than 1,026 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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