Phase 4
Completed N=87
A Study of the Comparable Efficacy and Safety of Pulmozyme (Dornase Alfa) Delivered by the eRapid Nebulizer System in Patients With Cystic Fibrosis
Source: ClinicalTrials.gov NCT01712334 ↗Enrolled (actual)
87
Serious AEs
0.0%
Results posted
May 2014
Primary outcomePrimary: Stability of Lung Function: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) — 98.1; 97.2 percent predicted
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Stability of Lung Function: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) |
98.1; 97.2 | — |
| PRIMARY Safety: Number of Participants With Adverse Events During Each Treatment Period |
18; 24 | — |
Eligibility Criteria
Inclusion Criteria
- Male and female patients, >/= 6 years of age
- Confirmed diagnosis of cystic fibrosis (CF)
- Receiving Pulmozyme once daily chronically for treatment of CF for at least 6 months prior to screening
- Percent predicted FEV1 >/= 40% at screening based on the Wang (males /= 18 years, females >/= 16 years) standardized equations
- Able to reproducibly perform spirometry testing and comply with study assessments
Exclusion Criteria
- An acute respiratory infection or pulmonary exacerbation within 4 weeks prior to randomization
- Initiation of any new chronic therapy (e.g. inhaled corticosteroids, inhaled oral antibiotics, high-dose ibuprofen, hypertonic saline, ivacaftor) for respiratory disease within 4 weeks prior to randomization
- Changes in chest physiotherapy schedule within 4 weeks prior to randomization
- Hospitalization within 4 weeks prior to randomization
- Planned hospitalization during the 6-week study
- History of organ transplantation
- Participation in an investigational drug or device study within 30 day prior to screening
Data sourced from ClinicalTrials.gov (NCT01712334). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.