Self-dispersing Liquids as Aerosol Drug Carriers

NCT00628134 | Completed Results DMC

• 2 other identifiers: PRO07090095CORCOR07A0
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystic Fibrosis

Keywords

cystic fibrosis; surfactant; aerosol; inhaled drug; inhaled antibiotic

Outcome Measures

Primary Outcomes (1)

• Uniformity of Aerosol Distribution

  Measured change in central/peripheral (c/p) dose ratio over a 30 minute period after aersol delivery (c/p at t=30 - c/p at t=0). Central and peripheral lung doses are measured as radioactive counts depicted on nuclear medicine gamma camera images after radioisotope aerosol delivery. The central lung zone is a rectangle with 1/2 the height and 1/2 the width of a box outlining the whole right lung. The peripheral lung zone is defined as the portion of the lung outside of the central lung zone. A change in c/p ratio over time would indicate transport of material from one lung zone to the other. The variable represents the realtive proportion of airways dosing to alveolar dosing - an indication of deposition uniformity in the lungs.

  30 minutes

Secondary Outcomes (1)

• Peripheral Lung Dose

  30 minutes after delivery

Study Arms (2)

1

EXPERIMENTAL

Subjects inhaled calfactant then isotonic saline

Drug: calfactant; Drug: isotonic saline

2

EXPERIMENTAL

Subjects inhaled isotonic saline then calfactant

Drug: calfactant; Drug: isotonic saline

Interventions

calfactant DRUG

single inhaled dose by nebulizer

Also known as: Infasurf

1; 2

isotonic saline DRUG

single inhaled dose by nebulizer

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pittsburgh: lead
• Cystic Fibrosis Foundation: collaborator

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

• 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.

  PMID: 22393908 RESULT

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

calfactant; Sodium Chloride

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Limitations and Caveats

Our aerosol delivery method resulted in more peripheral distribution than was anticipated. The more peripheral deposition pattern likely affected the location and quantity of deposited calfactant available to cause transport.

Results Point of Contact

• Title: Tim Corcoran, Ph.D.
• Organization: University of Pittsburgh

corcorante@upmc.edu

412-624-8918

Study Officials

• Tim Corcoran, Ph.D.

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 22, 2008
• First Posted: March 4, 2008
• Study Start: March 1, 2008
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: August 24, 2017
• Results First Posted: November 7, 2013

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will share

Locations

US (1)