Trials / Terminated
TerminatedNCT00434278
A Trial of Pulmozyme Withdrawal on Exercise Tolerance in Cystic Fibrosis Subjects With Severe Lung Disease (TOPIC)
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Pulmozyme Withdrawal on Exercise Tolerance in Cystic Fibrosis Subjects With Severe Lung Disease
- Status
- Terminated
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 27 (actual)
- Sponsor
- Genentech, Inc. · Industry
- Sex
- All
- Age
- 14 Years
- Healthy volunteers
- Not accepted
Summary
This was a multicenter, randomized, double-blind, placebo-controlled study of patients with severe, though stable, cystic fibrosis (CF) whose routine treatment included Pulmozyme. Patients were randomized to either continue Pulmozyme or have therapy withdrawn for 2 weeks (placebo group). Patients must have had stable CF symptoms without any change in therapy for 2 weeks prior to enrollment in order to participate.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Dornase alfa | 2.5 mg inhalation dose twice daily for 14±2 days |
| DRUG | placebo | 2.5 mg inhalation dose twice daily for 14±2 days |
Timeline
- Start date
- 2007-03-01
- Primary completion
- 2008-11-01
- Completion
- 2008-11-01
- First posted
- 2007-02-13
- Last updated
- 2017-05-16
- Results posted
- 2010-11-16
Locations
40 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00434278. Inclusion in this directory is not an endorsement.