A Study of the Comparable Efficacy and Safety of Pulmozyme (Dornase Alfa) Delivered by the eRapid Nebulizer System in Patients With Cystic Fibrosis
Public ClinicalTrials.gov record NCT01712334. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase IV Multicenter, Randomized, Open Label, Two-Period, Crossover Study in Patients With Cystic Fibrosis to Evaluate the Comparable Efficacy and Safety of Pulmozyme Delivered by the eRapid Nebulizer System
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01712334
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 99 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 6 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 2012 (Type not available)
- Primary completion
- Jun 2013 (Actual)
- Completion
- Jun 2013 (Actual)
- Last update posted
- May 1, 2014
2012 – 2013
United States locations
- U.S. sites
- 16
- U.S. states
- 15
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Phoenix | Arizona | 85016 | — |
| Not listed | Little Rock | Arkansas | 72202 | — |
| Not listed | Portland | Maine | 4102 | — |
| Not listed | Boston | Massachusetts | 02115 | — |
| Not listed | Lebanon | New Hampshire | 03756 | — |
| Not listed | Long Branch | New Jersey | 07740 | — |
| Not listed | Rochester | New York | 14618 | — |
| Not listed | Durham | North Carolina | 27710 | — |
| Not listed | Akron | Ohio | 44308 | — |
| Not listed | Cleveland | Ohio | 44106 | — |
| Not listed | Charleston | South Carolina | 29425 | — |
| Not listed | Sioux Falls | South Dakota | 57104 | — |
| Not listed | Nashville | Tennessee | 37232-9119 | — |
| Not listed | Houston | Texas | 77030 | — |
| Not listed | Salt Lake City | Utah | 84132 | — |
| Not listed | Seattle | Washington | 98105 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01712334, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 1, 2014 · Synced Oct 17, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01712334 live on ClinicalTrials.gov.