A Trial of Pulmozyme Withdrawal on Exercise Tolerance in Cystic Fibrosis Subjects With Severe Lung Disease (TOPIC)
Public ClinicalTrials.gov record NCT00434278. 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 Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Pulmozyme Withdrawal on Exercise Tolerance in Cystic Fibrosis Subjects With Severe Lung Disease
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 Patients were randomized to either continue Pulmozyme or have therapy withdrawn for 2 weeks (placebo group).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.
Study identification
- NCT ID
- NCT00434278
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 27 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 14 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
- Mar 2007 (Type not available)
- Primary completion
- Nov 2008 (Actual)
- Completion
- Nov 2008 (Actual)
- Last update posted
- May 16, 2017
2007 – 2008
United States locations
- U.S. sites
- 40
- U.S. states
- 22
- U.S. cities
- 39
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama | Birmingham | Alabama | 35233 | — |
| Childrens Hospital of LA | Los Angeles | California | 90027 | — |
| USC Adult CF Center | Los Angeles | California | 90033 | — |
| CHOC | Orange | California | 92868 | — |
| Capital Allergy Resp Dis Ctr | Sacramento | California | 95819 | — |
| Ventura County Medical Ctr | Ventura | California | 93003 | — |
| Nat'l Jewish Med/Research Ctr | Denver | Colorado | 80206 | — |
| Pulm & Critical Care Assoc | Jacksonville | Florida | 32204 | — |
| Univ of Miami | Miami | Florida | 33136 | — |
| Central Florida Pulmonary Grou | Orlando | Florida | 32803 | — |
| Brown Univ School of Medicine | Atlanta | Georgia | 30322 | — |
| Medical College of Georgia | Augusta | Georgia | 30912 | — |
| Rush Medical Center | Chicago | Illinois | 60612 | — |
| Univ of Kentucky Med Ctr | Lexington | Kentucky | 40536 | — |
| Univ of Michigan Hlth System | Ann Arbor | Michigan | 48109-5212 | — |
| Wayne State University | Detroit | Michigan | 48201 | — |
| Spectrum Hospital | Grand Rapids | Michigan | 49503 | — |
| Michigan State University | Kalamazoo | Michigan | 49008 | — |
| Univ of Minnesota Dept of Derm | Minneapolis | Minnesota | 55455 | — |
| University of Mississippi | Jackson | Mississippi | 39216-4505 | — |
| Pulmonary & Critical Care Med | St Louis | Missouri | 63110 | — |
| Children's Lung Specialist | Las Vegas | Nevada | 89107 | — |
| Monmouth Medical Center | Long Branch | New Jersey | 07740 | — |
| Morristown Memorial Hospital | Morristown | New Jersey | 07962 | — |
| St. Peters Univ Hospital | New Brunswick | New Jersey | 08901 | — |
| University of New Mexico | Albuquerque | New Mexico | 87131-0001 | — |
| Albany Medical College | Albany | New York | 12208 | — |
| Long Island Jew Adult CF Ctr | New Hyde Park | New York | 11040 | — |
| SUNY Upstate Medical Univ | Syracuse | New York | 13210 | — |
| Duke Pediatric Clinical | Durham | North Carolina | 27710 | — |
| Rainbow Babies & Child Hosp | Cleveland | Ohio | 44106 | — |
| Toledo Childrens Hospital | Toledo | Ohio | 43606 | — |
| Santiago Reyes MD-Private Prac | Oklahoma City | Oklahoma | 73112 | — |
| CF Solutions, Inc | Tulsa | Oklahoma | 74145 | — |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15260 | — |
| Medical Univ of South Carolina | Charleston | South Carolina | 29425 | — |
| Pediatric Pulmonary Assoc | Columbia | South Carolina | 29203 | — |
| Baylor College of Medicine | Houston | Texas | 77030 | — |
| Alamo Clinical Research Assoc | San Antonio | Texas | 78212 | — |
| W Virginia Univ Health Sci Ctr | Morgantown | West Virginia | 26506 | — |
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 NCT00434278, 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 16, 2017 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00434278 live on ClinicalTrials.gov.