Self-Dispersing Liquids as Aerosol Drug Carriers - Full Text View

Sponsors and Collaborators:	University of Pittsburgh Cystic Fibrosis Foundation
Information provided by:	University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT00628134

Purpose

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. It will include subjects both with and without cystic fibrosis.

Condition	Intervention
Cystic Fibrosis	Drug: calfactant aerosol Drug: isotonic saline aerosol

Genetics Home Reference related topics: cystic fibrosis

MedlinePlus related topics: Cystic Fibrosis

Drug Information available for: Calfactant

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Single Blind (Outcomes Assessor), Placebo Control, Crossover Assignment
Official Title:	Self-Dispersing Liquids as Aerosol Drug Carriers

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:

Uniformity of aerosol distribution [ Time Frame: 30 minutes after delivery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

peripheral lung dose [ Time Frame: 30 minutes after delivery ] [ Designated as safety issue: No ]

Estimated Enrollment:	16
Study Start Date:	March 2008
Estimated Study Completion Date:	February 2010
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Subjects with cystic fibrosis	Drug: calfactant aerosol single inhaled dose, 3ml by nebulizer Drug: isotonic saline aerosol single inhaled dose, 3ml by nebulizer
2: Experimental Healthy subjects	Drug: calfactant aerosol single inhaled dose, 3ml by nebulizer Drug: isotonic saline aerosol single inhaled dose, 3ml by nebulizer

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Age ≥ 18 years
Diagnosis of cystic fibrosis as determined by sweat test or genotype and clinical symptoms (CF subjects only)
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00628134

Contacts

Contact: Liz Hartigan, RN, MPH

412-692-7060

Elizabeth.Hartigan@chp.edu

Locations

United States, Pennsylvania
University of Pittsburgh Medical Center	Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Elizabeth Hartigan, RN, MPH 412-692-7060 Elizabeth. Hartigan@chp.edu
Principal Investigator: Tim Corcoran, Ph.D.

Sponsors and Collaborators

University of Pittsburgh

Cystic Fibrosis Foundation

Investigators

Principal Investigator:

Tim Corcoran, Ph.D.

University of Pittsburgh

More Information

Responsible Party:	University of Pittsburgh ( Tim Corcoran, Ph.D. )
Study ID Numbers:	PRO07090095, CORCOR07A0
Study First Received:	February 22, 2008
Last Updated:	June 2, 2008
ClinicalTrials.gov Identifier:	NCT00628134
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Pittsburgh:

cystic fibrosis
surfactant
aerosol
inhaled drug
inhaled antibiotic

Study placed in the following topic categories:

Digestive System Diseases
Genetic Diseases, Inborn
Respiratory Tract Diseases
Cystic Fibrosis
Fibrosis

Lung Diseases
Infant, Newborn, Diseases
Pancreatic Diseases
Calfactant
Cystic fibrosis

Additional relevant MeSH terms:

Respiratory System Agents
Pathologic Processes
Therapeutic Uses
Pharmacologic Actions
Pulmonary Surfactants

ClinicalTrials.gov processed this record on January 16, 2009