Self-dispersing Liquids as Aerosol Drug Carriers

• Status: Completed
• Trial end date: 2009-08-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Pittsburgh
• Collaborators: Cystic Fibrosis Foundation; Cystic Fibrosis Foundation Therapeutics
• Treatments: Calfactant

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.