Phase 1
N=20
Absorptive Clearance After Inhaled Osmotics in Cystic Fibrosis
Cystic Fibrosis
Bottom Line
View on ClinicalTrials.gov: NCT01223183 ↗Enrolled (actual)
20
Serious AEs
5.0%
Results posted
Feb 2018
Primary outcome: Primary: Absorptive Clearance Rate After Isotonic Saline Inhalation — 32.0 percent cleared / 80 minutes
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- hypertonic saline (7%) (Drug); isotonic saline (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Pittsburgh
- Primary completion
- Dec 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Absorptive Clearance Rate After Isotonic Saline Inhalation |
32.0 | — |
| PRIMARY Absorptive Clearance Rate After Hypertonic Saline Inhalation |
22.2 | <0.001 sig |
| PRIMARY Mucociliary Clearance Rate After Isotonic Saline Inhalation |
23.6 | — |
| PRIMARY Mucociliary Clearance Rate After Hypertonic Saline Inhalation |
42.4 | 0.003 sig |
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.
Eligibility Criteria
Inclusion Criteria
- 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)
Exclusion Criteria
- 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)
Data sourced from ClinicalTrials.gov (NCT01223183). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.