Status:
COMPLETED
Self-dispersing Liquids as Aerosol Drug Carriers
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
Cystic Fibrosis Foundation
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Inhaled medications are often used to treat lung diseases such as cystic fibrosis. We are performing this study to determine whether inhaled medications dissolved in surfactant-based solutions will di...
Detailed Description
Cystic fibrosis (CF) is an inherited chronic disease that affects the lungs and digestive system of about 30,000 children and adults in the United States (70,000 worldwide). The lungs of a person with...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- Diagnosis of cystic fibrosis as determined by sweat test or genotype and clinical symptoms
- Clinically stable as determined by the investigator (pulmonologist).
Exclusion
- Known allergies to any of the administered components (as described by subjects or based on positive RAST test to bovine serum albumin)
- Any past instances of bronchospasm associated with aerosol medications
- FEV1 \< 60% predicted
- Positive urine pregnancy test (as administered to all female subjects of childbearing potential on testing days)
- Currently a nursing mother
- History of reactive airways disease associated with significant instances of bronchoconstriction
- Self-reported smoking history within the last 6 months.
- Subjects receiving any treatments or diagnostic procedures involving radioisotopes within the last 30 days.
- Subjects in the CF arm of the study will also be excluded if their pre-study pulmonary function test (FEV1) is more than 15% depressed from their last baseline pulmonary function test, if this baseline value is from within the last 6 months, or if they have experienced an exacerbation requiring hospitalization or treatment with an IV antibiotic within the last month.
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00628134
Start Date
March 1 2008
End Date
August 1 2009
Last Update
August 24 2017
Active Locations (1)
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1
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213