Absorptive Clearance After Inhaled Osmotics in Cystic Fibrosis

Completed · Phase 1

Conditions studied: Cystic Fibrosis

In brief

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.

Key facts

Study ID

NCT01223183

Run by

University of Pittsburgh

People needed

20

Starts

2010-09-01

Expected to finish

2012-12-01

Last updated by the study team

2018-11-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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)

Where it is running

• University of Pittsburgh — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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