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NCT01712334 · ClinicalTrials.gov registry record · Phase 4
A Study of the Comparable Efficacy and Safety of Pulmozyme (Dornase Alfa) Delivered by the eRapid Nebulizer System in Patients With Cystic Fibrosis
A Phase 4 study, sponsored by Genentech.
- Completed
- Registry status
- Phase 4
- Development phase
- 99
- Enrollment target
NCT01712334 is a Phase 4 study that has completed, run by Genentech. The registered enrollment target is 99 participants.
The verdict
NCT01712334, a Phase 4 study, has completed, sponsored by Genentech.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 99 participants
- Enrollment target
Study Summary
This phase IV, multicenter, randomized, open-label, two-period crossover study will evaluate the comparable efficacy and safety of Pulmozyme (dornase alfa) delivered by the eRapid nebulizer system in patients with cystic fibrosis. Patients who have been receiving Pulmozyme once daily chronically for at least 6 months will continue to receive Pulmozyme once daily for a run-in period of 2 weeks using the Pari LC Plus nebulizer. Patients will then be randomized to receive in a crossover design Pulmozyme once daily for two treatment periods of 2 weeks each using either the Pari LC Plus or the eRapid nebulizer. Anticipated time on study treatment is 6 weeks.
Interventions
- DRUG dornase alfa [Pulmozyme®]
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 99 participants |
| Start Date | 2012-12 |
| Est. Completion | 2013-06 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01712334
The ClinicalTrials.gov registry entry for NCT01712334 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 99 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Genentech, which has 332 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which dornase alfa [Pulmozyme®] is the first listed.
NCT01712334 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01712334 about?
NCT01712334 is a clinical study titled "A Study of the Comparable Efficacy and Safety of Pulmozyme (Dornase Alfa) Delivered by the eRapid Nebulizer System in Patients With Cystic Fibrosis". This phase IV, multicenter, randomized, open-label, two-period crossover study will evaluate the comparable efficacy and safety of Pulmozyme (dornase alfa) delivered by the eRapid nebulizer system in patients with cystic fibrosis. Patients who have been receiving Pulmozyme once daily chronically for...
What is the current status of trial NCT01712334?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 99 participants. The study started on 2012-12. Estimated completion is 2013-06.
What interventions are being tested in trial NCT01712334?
The interventions under investigation include: dornase alfa [Pulmozyme®] (DRUG).
Who is sponsoring clinical trial NCT01712334?
This trial is sponsored by Genentech, which has 332 total clinical trials registered on ClinicalTrials.gov.
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