Self-dispersing Liquids as Aerosol Drug Carriers
Completed · Not applicable
Conditions studied: Cystic Fibrosis
In brief
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 distribute more evenly throughout the lungs when compared to standard saline-based solutions. We think that inhaling medication that is in a surfactant-based liquid will result in more medication reaching partially blocked parts of the lung. This study will use a special nuclear medicine test called an aerosol deposition scan to compare how a drug spreads in the lung using a surfactant-based aerosol compared to a saline-based aerosol.
Key facts
- Study ID
- NCT00628134
- Run by
- University of Pittsburgh
- People needed
- 8
- Starts
- 2008-03-01
- Expected to finish
- 2009-08-01
- Last updated by the study team
- 2017-08-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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.
Where it is running
- University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
Full record on ClinicalTrials.gov
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