Absorptive Clearance After Inhaled Osmotics in Cystic Fibrosis

NCT01223183 | Completed Phase 1 Results DMC

• 1 other identifier: PRO09080375
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Blockage of the breathing tubes of the lungs by thick, sticky mucus is a major cause of lung problems for people with cystic fibrosis (CF). Many researchers now believe that people with CF absorb too much water from the insides of their lungs, and that the mucus in their lungs becomes so thick and sticky because there is not enough water in it. The investigators are trying to develop ways to measure how fast water is absorbed from the breathing tubes in the lung so that the investigators can more quickly test new medications that are being developed to fix this problem for CF patients. The investigators have already done studies showing that people with CF absorb a particular radioactive drug (Indium-111 diethylenetriaminepentaacetic acid or In-DTPA) from their lungs more quickly than people without CF. Now the investigators are trying to prove that the absorption of this drug is related to the absorption of water. The investigators measure the absorption of In-DTPA by delivering it in an aerosol (inhaled mist) along with another radioactive drug (Technetium 99m sulfur colloid or Tc-SC). This other drug helps us measure how much material is cleared from the lungs in other ways (like coughing) without being absorbed. In this study, the investigators will measure how the absorption of In-DTPA is affected by inhaling isotonic saline and hypertonic saline (salt water), both of which the investigators know affect the absorption of water in the airways.

Conditions

Cystic Fibrosis

Keywords

cystic fibrosis; nuclear medicine; aerosol; nebulizer

Outcome Measures

Primary Outcomes (4)

• Absorptive Clearance Rate After Isotonic Saline Inhalation

  The absorption rate of Indium 111 diethylenetriaminepentaacetic acid (In-DTPA) in the airways after the inhalation of isotonic saline

  80 minutes after radiopharmaceutical inhalation

• Absorptive Clearance Rate After Hypertonic Saline Inhalation

  The absorption rate of In-DTPA after the inhalation of hypertonic saline

  80 minutes after radiopharmaceutical inhalation

• Mucociliary Clearance Rate After Isotonic Saline Inhalation

  The clearance rate of Tc-SC after the inhalation of isotonic saline

  80 minutes after radiopharmaceutical inhalation

• Mucociliary Clearance Rate After Hypertonic Saline Inhalation

  The clearance rate of Tc-SC after the inhalation of hypertonic saline

  80 minutes after radiopharmaceutical inhalation

Study Arms (2)

isotonic saline then hypertonic saline

ACTIVE COMPARATOR

Subjects inhaled nebulized isotonic saline on study day 1, and then after a 5-24 day washout period, subjects inhaled nebulized 7% hypertonic saline on study day 2.

Drug: hypertonic saline (7%); Drug: isotonic saline

hypertonic saline then isotonic saline

ACTIVE COMPARATOR

Subjects inhaled nebulized 7% hypertonic saline on study day 1, and then after a 5-24 day washout period, subjects inhaled nebulized isotonic saline on study day 2.

Drug: hypertonic saline (7%); Drug: isotonic saline

Interventions

hypertonic saline (7%) DRUG

single treatment by inhalation

hypertonic saline then isotonic saline; isotonic saline then hypertonic saline

isotonic saline DRUG

single treatment by inhalation

hypertonic saline then isotonic saline; isotonic saline then hypertonic saline

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:

• intolerant to hypertonic saline.
• FEV1%p \<40% of predicted
• nursing mother
• positive urine pregnancy test
• unwilling to stop hypertonic saline therapy for 72 hours prior to each test day
• cigarette smoker (regular smoking within 6 months of study)

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (3)

• Corcoran TE, Thomas KM, Myerburg MM, Muthukrishnan A, Weber L, Frizzell R, Pilewski JM. Absorptive clearance of DTPA as an aerosol-based biomarker in the cystic fibrosis airway. Eur Respir J. 2010 Apr;35(4):781-6. doi: 10.1183/09031936.00059009. Epub 2009 Aug 28.

  PMID: 19717485 BACKGROUND

• Locke LW, Myerburg MM, Markovetz MR, Parker RS, Weber L, Czachowski MR, Harding TJ, Brown SL, Nero JA, Pilewski JM, Corcoran TE. Quantitative imaging of airway liquid absorption in cystic fibrosis. Eur Respir J. 2014 Sep;44(3):675-84. doi: 10.1183/09031936.00220513. Epub 2014 Apr 17.

  PMID: 24743971 RESULT

• Locke LW, Myerburg MM, Weiner DJ, Markovetz MR, Parker RS, Muthukrishnan A, Weber L, Czachowski MR, Lacy RT, Pilewski JM, Corcoran TE. Pseudomonas infection and mucociliary and absorptive clearance in the cystic fibrosis lung. Eur Respir J. 2016 May;47(5):1392-401. doi: 10.1183/13993003.01880-2015. Epub 2016 Mar 23.

  PMID: 27009167 DERIVED

Related Links

• PACCM aerosol research

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Saline Solution, Hypertonic; 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)

Hypertonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Tim Corcoran
• Organization: University of Pittsburgh

corcorante@upmc.edu

412-624-8918

Study Officials

• Tim Corcoran, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: Subjects inhale isotonic saline on one imaging day and 7% hypertonic on the other. The order is randomized. There is a period of 5-24 days between imaging days.

Study Record Dates

• First Submitted: October 14, 2010
• First Posted: October 18, 2010
• Study Start: September 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: November 29, 2018
• Results First Posted: February 5, 2018

Record last verified: 2018-11

Locations

US (1)