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The purpose of this research study is to evaluate the safety and effectiveness of Interferon gamma-1b (IFN-g 1b) on lung function when given to patients with cystic fibrosis by inhalation (breathed into the lungs) three times a week for 12 weeks.
The FDA has not approved Interferon gamma-1b for use with cystic fibrosis patients, which is the condition being examined in this study.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| interferon gamma-1b | Drug | 500 or 1000 mcg, inhalation, 3x per week |
| Measure | Description | Time Frame |
|---|---|---|
| change in FEV1, sputum bacterial density | 12 weeks |
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Key inclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steve Porter, MD | InterMune | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | United States | ||||
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| Phoenix |
| Arizona |
| United States |
| Palo Alto | California | United States |
| Sacramento | California | United States |
| San Diego | California | United States |
| San Francisco | California | United States |
| Denver | Colorado | United States |
| Daytona Beach | Florida | United States |
| Orlando | Florida | United States |
| Chicago | Illinois | United States |
| New Orleans | Louisiana | United States |
| Rochester | Minnesota | United States |
| New York | New York | United States |
| Philadelphia | Pennsylvania | United States |
| Nashville | Tennessee | United States |
| Lackland Air Force Base | Texas | United States |
| Tyler | Texas | United States |
| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
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| ID | Term |
|---|---|
| C554125 | interferon gamma-1b |
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