Cystic Fibrosis Clinical Trial
— EVOLVEOfficial title:
A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 3 Trial to Assess the Efficacy and Safety of Tobramycin Inhalation Powder (TIP) in Cystic Fibrosis (CF) Subjects
| Verified date | October 2011 |
| Source | Novartis |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
Lung infections are a chronic problem for patients with cystic fibrosis (CF). Some patients with CF may have a type of bacteria called Pseudomonas aeruginosa in their lungs that can cause infections or make their symptoms worse. Tobramycin inhalation solution (TOBI) is an approved antibiotic, which is inhaled directly into the lungs, and can be used to manage these infections. Tobramycin inhalation powder (TIP) is a new, experimental powder formulation of tobramycin that is inhaled directly into the lungs using a T-326 inhaler. The purpose of this research study is to determine if TIP is safe and effective when compared to placebo (a powder with no medicine) treatment.
| Status | Terminated |
| Enrollment | 98 |
| Est. completion date | February 2007 |
| Est. primary completion date | February 2007 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 6 Years to 21 Years |
| Eligibility |
Inclusion Criteria: - Confirmed diagnosis of cystic fibrosis patients with Pseudomonas aeruginosa infection. - Male and female subjects between 6 and 21 years of age at the time of screening. - FEV1 at screening must be between 25% and 80% of normal predicted values. Exclusion Criteria: - Known local or systemic hypersensitivity to aminoglycosides or inhaled antibiotics. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Argentina | For information on a site near you, call 1-800-244-7668 Option "2" | Buenos Aires | |
| Argentina | For information on a site near you, call 1-800-244-7668 Option "2" | Cordoba | |
| Brazil | For information on a site near you, call 1-800-244-7668 Option "2" | Campinas | San Paolo |
| Brazil | For information on a site near you, call 1-800-244-7668 Option "2" | Curitiba | PR |
| Brazil | For information on a site near you, call 1-800-244-7668 Option "2" | Florianopolis | SC |
| Bulgaria | For information on a site near you, call 1-800-244-7668 Option "2" | Varna | |
| Canada | For information on a site near you, call 1-800-244-7668 Option "2" | Hamilton | Ontario |
| Canada | For information on a site near you, call 1-800-244-7668 Option "2" | Sainte-Foy | Quebec |
| Canada | For information on a site near you, call 1-800-244-7668 Option "2" | Vancouver | British Columbia |
| Chile | For information on a site near you, call 1-800-244-7668 Option "2" | Santiago | |
| Chile | For information on a site near you, call 1-800-244-7668 Option "2" | Viña del Mar | |
| Lithuania | For information on a site near you, call 1-800-244-7668 Option "2" | Vilnius | |
| Mexico | For information on a site near you, call 1-800-244-7668 Option "2" | Mexico City | |
| Mexico | For information on a site near you, call 1-800-244-7668 Option "2" | Monterrey | |
| Mexico | For information on a site near you, call 1-800-244-7668 Option "2" | Tijuana | |
| United States | For information on a site near you, call 1-800-244-7668 Option "2" | Ann Arbor | Michigan |
| United States | For information on a site near you, call 1-800-244-7668 Option "2" | Atlanta | Georgia |
| United States | For information on a site near you, call 1-800-244-7668 Option "2" | Augusta | Georgia |
| United States | For information on a site near you, call 1-800-244-7668 Option "2" | Charleston | South Carolina |
| United States | For information on a site near you, call 1-800-244-7668 Option "2" | Chicago | Illinois |
| United States | For information on a site near you, call 1-800-244-7668 Option "2" | Cleveland | Ohio |
| United States | For information on a site near you, call 1-800-244-7668 Option "2" | Columbus | Ohio |
| United States | For information on a site near you, call 1-800-244-7668 Option "2" | Durham | North Carolina |
| United States | For information on a site near you, call 1-800-244-7668 Option "2" | Fresno | California |
| United States | For information on a site near you, call 1-800-244-7668 Option "2" | Long Beach | California |
| United States | For information on a site near you, call 1-800-244-7668 Option "2" | Los Angeles | California |
| United States | For information on a site near you, call 1-800-244-7668 Option "2" | Mobile | Alabama |
| United States | For information on a site near you, call 1-800-244-7668 Option "2" | Morgantown | West Virginia |
| United States | For information on a site near you, call 1-800-244-7668 Option "2" | New Hyde Park | New York |
| United States | For information on a site near you, call 1-800-244-7668 Option "2" | New York | New York |
| United States | For information on a site near you, call 1-800-244-7668 Option "2" | Oak Lawn | Illinois |
| United States | For information on a site near you, call 1-800-244-7668 Option "2" | Oakland | California |
| United States | For information on a site near you, call 1-800-244-7668 Option "2" | Oklahoma City | Oklahoma |
| United States | For information on a site near you, call 1-800-244-7668 Option "2" | Orlando | Florida |
| United States | For information on a site near you, call 1-800-244-7668 Option "2" | Pensacola | Florida |
| United States | For information on a site near you, call 1-800-244-7668 Option "2" | Philadelphia | Pennsylvania |
| United States | For information on a site near you, call 1-800-244-7668 Option "2" | Phoenix | Arizona |
| United States | For information on a site near you, call 1-800-244-7668 Option "2" | Sacramento | California |
| United States | For information on a site near you, call 1-800-244-7668 Option "2" | Salt Lake City | Utah |
| United States | For information on a site near you, call 1-800-244-7668 Option "2" | Tyler | Texas |
| United States | For information on a site near you, call 1-800-244-7668 Option "2" | Valhalla | New York |
| Lead Sponsor | Collaborator |
|---|---|
| Novartis |
United States, Argentina, Brazil, Bulgaria, Canada, Chile, Lithuania, Mexico,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Forced expiratory volume in 1 second (FEV1) measured at week 1 and week 5. | |||
| Secondary | Time until first antipseudomonal antibiotic (an antibiotic used to treat bacteria of a certain type [the genus pseudomonas]) is used | |||
| Secondary | Relative changes in FEV1 % predicted for patients who received TIP starting at visit 1 and for patients who received placebo starting at week 9, compared to all subsequent visits. | |||
| Secondary | Relative change in FEV1 % predicted for patients who received placebo from week 5 to week 13 | |||
| Secondary | Relative change in FEV1 % predicted for patients who received placebo (from the average of four assessments [weeks 1, 2, 5, and 9] to week 13) | |||
| Secondary | Change from baseline in susceptibility of pseudomonas to the antibiotic during the study measured at weeks 5, 9, 13, 17, 21, and 25, and change from baseline in quantity of pseudomonas found in sputum during the study measured at weeks 5, 9, 13, 17, 21, |
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