Self-dispersing Liquids as Aerosol Drug Carriers

NCT ID: NCT00628134

Last Updated: 2017-08-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2009-08-31

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.

Conditions

Cystic Fibrosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

1

Subjects inhaled calfactant then isotonic saline

Group Type: EXPERIMENTAL

calfactant

Intervention Type: DRUG

single inhaled dose by nebulizer

isotonic saline

Intervention Type: DRUG

single inhaled dose by nebulizer

2

Subjects inhaled isotonic saline then calfactant

Group Type: EXPERIMENTAL

calfactant

Intervention Type: DRUG

single inhaled dose by nebulizer

isotonic saline

Intervention Type: DRUG

single inhaled dose by nebulizer

Interventions

calfactant

single inhaled dose by nebulizer

Intervention Type: DRUG

isotonic saline

single inhaled dose by nebulizer

Intervention Type: DRUG

Other Intervention Names

Infasurf

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cystic Fibrosis Foundation

OTHER

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Tim Corcoran

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tim Corcoran, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Countries

United States

References

Corcoran TE, Thomas KM, Garoff S, Tilton RD, Przybycien TM, Pilewski JM. Imaging the postdeposition dispersion of an inhaled surfactant aerosol. J Aerosol Med Pulm Drug Deliv. 2012 Oct;25(5):290-6. doi: 10.1089/jamp.2011.0920. Epub 2012 Mar 6.

Reference Type: RESULT

PMID: 22393908 (View on PubMed)

Other Identifiers

CORCOR07A0

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

PRO07090095

Identifier Type: -

Identifier Source: org_study_id