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NCT00434278 · ClinicalTrials.gov registry record · Phase 4
A Trial of Pulmozyme Withdrawal on Exercise Tolerance in Cystic Fibrosis Subjects With Severe Lung Disease (TOPIC)
A Phase 4 study, sponsored by Genentech.
- Terminated
- Registry status
- Phase 4
- Development phase
- 27
- Enrollment target
NCT00434278: Clinical Trial Phase 4 study, sponsored by Genentech.
NCT00434278 is a Phase 4 study that was terminated before completion, run by Genentech. The registered enrollment target is 27 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00434278, a Phase 4 study, was terminated before completion, sponsored by Genentech.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 27 participants
- Enrollment target
Study 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 Patients were randomized to either continue Pulmozyme or have therapy withdrawn for 2 weeks (placebo group).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.
Primary Outcome
Change in distance walked was defined as (distance walked in 6 minutes at baseline \[Day 0\]) - (distance walked in 6 minutes at Day 14) in meters.
Interventions
- DRUG placebo
- DRUG Dornase alfa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2007-03 |
| Est. Completion | 2008-11 |
| Phase | Phase 4 |
Why NCT00434278 stopped before completion
NCT00434278 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT00434278 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00434278 about?
NCT00434278 is a clinical study titled "A Trial of Pulmozyme Withdrawal on Exercise Tolerance in Cystic Fibrosis Subjects With Severe Lung Disease (TOPIC)". 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 mu...
What is the current status of trial NCT00434278?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 27 participants. The study started on 2007-03. Estimated completion is 2008-11.
What interventions are being tested in trial NCT00434278?
The interventions under investigation include: placebo (DRUG), Dornase alfa (DRUG).
Who is sponsoring clinical trial NCT00434278?
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 NCT00434278's enrollment target sits among peer trials
27 1651st of 2000 higher than 346 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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