N/A
N=8
Self-dispersing Liquids as Aerosol Drug Carriers
Cystic Fibrosis
Bottom Line
View on ClinicalTrials.gov: NCT00628134 ↗Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Nov 2013
Primary outcome: Primary: Uniformity of Aerosol Distribution — -0.05; 0.10 ratio — p=0.07
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- calfactant (Drug); isotonic saline (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Pittsburgh
- Primary completion
- Aug 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Uniformity of Aerosol Distribution |
-0.05; 0.10 | 0.07 |
| SECONDARY Peripheral Lung Dose |
-3; -8 | 0.29 |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00628134). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.