Study of Denufosol Tetrasodium Inhalation Solution in Patients With Cystic Fibrosis (CF) Lung Disease
Public ClinicalTrials.gov record NCT00625612. 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 3, International, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy and Safety Study of Denufosol Tetrasodium Inhalation Solution in Patients With Cystic Fibrosis Lung Disease and FEV1 Greater Than or Equal to 75% Predicted But Less Than or Equal to 110% Predicted
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this trial is to evaluate the safety and effectiveness of one dose strength of Denufosol compared to placebo in patients with CF and a predicted FEV1 of greater than or equal to 75% but less than or equal to 110% predicted.
Study identification
- NCT ID
- NCT00625612
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 466 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 5 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
- Feb 2008 (Type not available)
- Primary completion
- Oct 2010 (Actual)
- Completion
- Oct 2010 (Actual)
- Last update posted
- Nov 2, 2015
2008 – 2010
United States locations
- U.S. sites
- 82
- U.S. states
- 38
- U.S. cities
- 75
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | — |
| Pediatric Breathing Disorders | Anchorage | Alaska | 99508 | — |
| Phoenix Childrens Hospital | Phoenix | Arizona | 85016 | — |
| University of Arizona/Arizona Health Sciences | Tucson | Arizona | 85724 | — |
| Childrens Hospital of Los Angeles | Los Angeles | California | 90027 | — |
| USC Cystic Fibrosis Center | Los Angeles | California | 90033 | — |
| Bay Area Pediatric Pulmonary | Oakland | California | 94609 | — |
| Kaiser Permanente Medical Center | Oakland | California | 94611 | — |
| Children's Hospital of Orange County | Orange | California | 92868 | — |
| Sanford University | Palo Alto | California | 94304 | — |
| Capital Allergy & Respiratory Disease Center | Sacramento | California | 95819 | — |
| UCSD Medical Center - Hillcrest & Thornton Hospitals | San Diego | California | 92103 | — |
| UCSD Medical Center - Hillcrest and Thornton Hospitals | San Diego | California | 92103 | — |
| Pediatric Diagnostic Center | Ventura | California | 93003 | — |
| Yale School of Medicine | New Haven | Connecticut | 06520 | — |
| Alfred I. duPont Hospital for Children | Wilmington | Delaware | 19803 | — |
| Children's National Medical Center | Washington D.C. | District of Columbia | 20010 | — |
| Shands at University of Florida | Gainesville | Florida | 32610 | — |
| Nemours Children's Clinic | Jacksonville | Florida | 32207 | — |
| Nemours Children's Clinic | Pensacola | Florida | 32504 | — |
| Pediatric Pulmonary Associates | St. Petersburg | Florida | 33701 | — |
| Tampa General Hospital | Tampa | Florida | 33606 | — |
| St. Mary's Medical Center | West Palm Beach | Florida | 33407 | — |
| Emory University | Atlanta | Georgia | 30322 | — |
| Children's Healthcare of Atlanta at Scottish Rite | Atlanta | Georgia | 30342 | — |
| Medical College of Georgia | Augusta | Georgia | 30912 | — |
| Children's Memorial Hospital | Chicago | Illinois | 60614 | — |
| Cystic Fibrosis Institute | Glenview | Illinois | 60025 | — |
| James Whitcomb RIley Hospital for Children | Indianapolis | Indiana | 46202 | — |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | — |
| Via Christa Research | Wichita | Kansas | 67214 | — |
| University of Kentucky | Lexington | Kentucky | 40536 | — |
| Tulane University Medical Center | New Orleans | Louisiana | 70112 | — |
| Maine Medical Center | Portland | Maine | 04102 | — |
| Johns Hopkins University School of Medicine | Baltimore | Maryland | 21287 | — |
| Boston Children's Hospital | Boston | Massachusetts | 02115 | — |
| University of Michigan Health System | Ann Arbor | Michigan | 48109 | — |
| Spectrum Health Hospitals | Grand Rapids | Michigan | 49503 | — |
| Children's Health Care | Minneapolis | Minnesota | 55404 | — |
| University of Minnesota - Farview | Minneapolis | Minnesota | 55455 | — |
| Childrens Mercy Hospital | Kansas City | Missouri | 64108 | — |
| Saint Louis University | St Louis | Missouri | 63104 | — |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | — |
| Children's Lung Specialists | Las Vegas | Nevada | 83107 | — |
| Saint Barnabas Medical Center | Livingston | New Jersey | 07039 | — |
| Monmouth Medical Center | Long Branch | New Jersey | 07740 | — |
| The Respiratory Center for Children | Morristown | New Jersey | 07960 | — |
| Albany Medical College | Albany | New York | 12208 | — |
| Cystic Fibrosis Center of Schneider Children's Hospital | Great Neck | New York | 11021 | — |
| New York Medical College | Hawthorne | New York | 10532 | — |
| Long Island Jewish Medical Center | New Hyde Park | New York | 11040 | — |
| St. Vincent's Catholic Medical Center | New York | New York | 10011 | — |
| Columbia University Medical Center | New York | New York | 10032 | — |
| University of Rochester | Rochester | New York | 14642 | — |
| SUNY Upstate Medical University Hospital | Syracuse | New York | 13210 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| St. Alexius Medical Center | Bismarck | North Dakota | 58501 | — |
| Children's Hospital Medical Center of Akron | Akron | Ohio | 44308 | — |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | — |
| University Hospital of Cleveland | Cleveland | Ohio | 44106 | — |
| Columbus Children's Hospital | Columbus | Ohio | 43205 | — |
| The Children's Medical Center of Dayton | Dayton | Ohio | 45404 | — |
| Toledo Children's Hospital | Toledo | Ohio | 43606 | — |
| Santiago Reyes, MD | Oklahoma City | Oklahoma | 73112 | — |
| Oregon Health and Science University | Portland | Oregon | 97239 | — |
| PennState Milton S Hershey Med | Hershey | Pennsylvania | 17033 | — |
| The Childrens Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | — |
| Childrens Hospital of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| Sanford Childrens' Specialty Clinic | Sioux Falls | South Dakota | 57117 | — |
| East Tennesse Children's Hospital - Pediatric Pulmonary and Respiratory Care | Knoxville | Tennessee | 37916 | — |
| Austin Children's Chest Associates | Austin | Texas | 78723 | — |
| Dallas Cystic Fibrosis Center | Dallas | Texas | 75235 | — |
| Baylor College of Medicine | Houston | Texas | 77030 | — |
| University of Utah | Salt Lake City | Utah | 84132 | — |
| University of Virginia | Charlottesville | Virginia | 22908 | — |
| Children's Hospital of the King's Daughters | Norfolk | Virginia | 23507 | — |
| Naval Medical Center Portsmouth | Portsmouth | Virginia | 84132 | — |
| Pediatric Pulmonary Clinic | Richmond | Virginia | 23219 | — |
| West Virginia University | Morgantown | West Virginia | 26506 | — |
| University of Wisconsin Hospital and Clinics | Madison | Wisconsin | 53792 | — |
| University of Wisconsin School of Medicine and Pulbic Health | Madison | Wisconsin | 53792 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 24 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00625612, 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 Nov 2, 2015 · Synced Oct 29, 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 NCT00625612 live on ClinicalTrials.gov.