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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: Completed Phase 4 study, sponsored by Genentech.
NCT01712334 is a Phase 4 study that has completed, run by Genentech. The registered enrollment target is 99 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Spirometry was performed according to American Thoracic Society standards. FEV1 is the amount of air that is forced out of the lungs in one second and was measured at the end of each 2-week treatment period. The percent predicted FEV1 was calculated as: Percent predicted FEV1 =FEV1 (L) / Predicted FEV1 (L) ×100.
Interventions
- DRUG dornase alfa [Pulmozyme®]
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 99 participants |
| Start Date | 2012-12 |
| Est. Completion | 2013-06 |
| Phase | Phase 4 |
What the finished NCT01712334 record still lists
NCT01712334 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 99 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (81% lower).
The record links to 0 conditions, and to 1 intervention - of which dornase alfa [Pulmozyme®] is the first listed.
NCT01712334 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01712334's enrollment target sits among peer trials
99 853rd of 2000 higher than 1,147 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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