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NCT01223183 · ClinicalTrials.gov registry record · Phase 1

Absorptive Clearance After Inhaled Osmotics in Cystic Fibrosis

A Phase 1 study, sponsored by University of Pittsburgh.

Completed
Registry status
Phase 1
Development phase
20
Enrollment target

NCT01223183 is a Phase 1 study that has completed, run by University of Pittsburgh. The registered enrollment target is 20 participants.

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The verdict

NCT01223183, a Phase 1 study, has completed, sponsored by University of Pittsburgh.

COMPLETED
Registry status
Phase 1
Development phase
20 participants
Enrollment target

Study 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.

Interventions

  • DRUG hypertonic saline (7%)
  • DRUG isotonic saline

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2010-09
Est. Completion 2012-12
Phase Phase 1

Sponsor

University of Pittsburgh

1,238 total trials

What the Registry Record Tells You About NCT01223183

The ClinicalTrials.gov registry entry for NCT01223183 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pittsburgh, which has 1,238 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which hypertonic saline (7%) is the first listed.

NCT01223183 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01223183 about?

NCT01223183 is a clinical study titled "Absorptive Clearance After Inhaled Osmotics in Cystic Fibrosis". 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 s...

What is the current status of trial NCT01223183?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2010-09. Estimated completion is 2012-12.

What interventions are being tested in trial NCT01223183?

The interventions under investigation include: hypertonic saline (7%) (DRUG), isotonic saline (DRUG).

Who is sponsoring clinical trial NCT01223183?

This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.