Conditions: Cystic Fibrosis
Keywords: cystic fibrosis surfactant aerosol inhaled drug inhaled antibiotic
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 8
Healthy volunteers: no

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 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.

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 cystic fibrosis often contain thick sticky mucus that can clog the lungs and lead to life-threatening lung infections. A major milestone in the treatment of CF was the development of an inhaled form of an antibiotic drug called tobramycin. For an inhaled antibiotic to work it must be delivered to all infected parts of the lung. Many studies have shown that blockages in the lungs, like those found in CF patients, can prevent inhaled medicines from reaching all parts of the lungs.

Usually aerosolized medications are dissolved in saline or water. Most of these medications could be dissolved in surfactant solutions and aerosolized. Soaps are common examples of surfactants. Surfactants may have the ability to spread medication over the inside surface of the lungs similar to the way dish soap spreads over water. We think that inhaling medication that is in a surfactant-based liquid will result in more medication reaching partially blocked parts of the lung. We further believe that the normal movements of the lung associated with breathing will further spread surfactant-based aerosol medications, and contribute to even more even drug distribution over longer periods of time.

A surfactant-based inhaled antibiotic would have the potential to reach more sites of infection in the lung, possibly getting rid of infection all together. This study will use a special 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. The study includes one screening and two testing visits.

Arms:
arm 1: Subjects inhaled calfactant then isotonic saline arm 2: Subjects inhaled isotonic saline then calfactant

Interventions: intervention 1: calfactant intervention 2: isotonic saline
Intervention descriptions: intervention 1: single inhaled dose by nebulizer intervention 2: single inhaled dose by nebulizer

Protocol document: