Study of Denufosol Tetrasodium Inhalation Solution in Patients With Cystic Fibrosis (CF) Lung Disease
| Status: | Completed |
|---|---|
| Conditions: | Pulmonary, Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 5 - Any |
| Updated: | 4/21/2016 |
| Start Date: | February 2008 |
| End Date: | October 2010 |
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
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.
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.
Inclusion Criteria:
- Have confirmed diagnosis of cystic fibrosis
- Have FEV1 of greater than or equal to 75% but less than or equal to 110%predicted
normal for age, gender and height
- Be able to reproducibly perform spirometry
- Be clinically stable for at least 4 weeks before screening
Exclusion Criteria:
- Have abnormal renal or liver function
- Have lung transplant
- Unable to discontinue use of hypertonic saline
- Participated in Inspire trial 08-108
We found this trial at
82
sites
111 Michigan Ave NW
Washington, District of Columbia
Washington, District of Columbia
(202) 476-5000
Childrens National Medical Center As the nation’s children’s hospital, the mission of Children’s National Medical...
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Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
Cincinnati, Ohio 45229
1-513-636-4200
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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Nemours Children's Clinic At Nemours Children’s Clinic, Jacksonville, we've treated every child as we would...
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Children's Mercy Hospital Children's Mercy Hospitals and Clinics continues redefining pediatric medicine throughout the Midwest...
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Childrens Hospital Los Angeles Children's Hospital Los Angeles is a 501(c)(3) nonprofit hospital for pediatric...
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601 Children's Lane
Norfolk, Virginia 23507
Norfolk, Virginia 23507
(757) 668-7000
Children's Hospital of The King's Daughters Children
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Children's Hospital of Orange County For more than 45 years, CHOC Children’s has been steadfastly...
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Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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Maine Medical Center One of the country's consistently highest rated hospitals is right in your...
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
Portland, Oregon 97239
503 494-8311
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Naval Medical Center - Portsmouth Naval Medical Center Portsmouth, Virginia has proudly served the military...
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University of Rochester The University of Rochester is one of the country's top-tier research universities....
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University of Utah Research is a major component in the life of the U benefiting...
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SUNY Upstate Medical University Hospital SUNY Upstate Medical University in Syracuse, NY, is the only...
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Tampa General Hospital In a diverse city known for its rich culture and beautiful beaches,...
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Alfred I. duPont Hospital for Children Nemours began more than 70 years ago with the...
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Albany Medical College Albany Medical Center is northeastern New York's only academic health sciences center...
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1500 E Medical Center Dr
Ann Arbor, Michigan 48109
Ann Arbor, Michigan 48109
(734) 936-4000
University of Michigan Health System The University of Michigan is home to one of the...
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733 North Broadway
Baltimore, Maryland 21205
Baltimore, Maryland 21205
(410) 955-3182
Johns Hopkins University School of Medicine Johns Hopkins Medicine (JHM), headquartered in Baltimore, Maryland, is...
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Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
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171 Ashley Avenue
Charleston, South Carolina 29425
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
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Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
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Knoxville, Tennessee 37916
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University of Kentucky The University of Kentucky is a public, land grant university dedicated to...
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Saint Barnabas Medical Center As a Barnabas Health facility, Saint Barnabas Medical Center is committed...
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600 Highland Ave
Madison, Wisconsin 53792
Madison, Wisconsin 53792
(608) 263-6400
University of Wisconsin Hospital and Clinics UW Health strives to meet the health needs of...
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West Virginia University West Virginia University, founded in 1867, has a long and rich history...
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Long Island Jewish Medical Center Serving North Shore LIJ Health System employees and their families....
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Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
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Phoenix Children's Hospital Phoenix Children's Hospital has provided hope, healing, and the best healthcare for...
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Saint Louis University Saint Louis University is a Catholic, Jesuit institution with campuses in St....
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