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NCT01887197
Repeatability and Response Study of Absorptive Clearance Scans
Phase 1 trial testing Absorptive clearance scan in Cystic Fibrosis in 24 participants. Completed in 1 May 2018.
1 December 2017
Quick facts
| Lead sponsor | Tim Corcoran |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | single group |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 24 |
| Start date | 1 June 2013 |
| Primary completion | 1 December 2017 |
| Estimated completion | 1 May 2018 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Absorptive clearance scan
- inhaled hypertonic saline (7%) — full drug profile →
- mannitol inhalation powder — full drug profile →
Conditions studied
- Cystic Fibrosis — all drugs for Cystic Fibrosis →
Sponsor
Tim Corcoran — full company profile →
Who can join
18 and older, any sex, with Cystic Fibrosis. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
absorptive clearance variability
Time frame: 30 days
The difference in absorptive clearance measured on two different study days in the same subjects as an indicator of measurement variability -
absorptive clearance response
Time frame: 14 day
The change in absorptive clearance demonstrated in response to therapy when compared to baseline
Sponsor's own description
The investigators are developing a new nuclear medicine imaging technique for measuring liquid absorption in the airways that can be applied to screen new medications being developed to treat cystic fibrosis (CF). The investigators believe that the absorption of the small molecule radiopharmaceutical Indium 111 diethylene triamine pentaacetic acid (In-DTPA) will indicate changes in liquid absorption in the airways and demonstrate whether new CF medications will be effective. In this study the investigators will determine whether the imaging technique will demonstrate similar results when it is repeated on different days. They will also determine how their results change when subjects utilize several common CF medications.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Pseudomonas infection and mucociliary and absorptive clearance in the cystic fibrosis lung.
Locke LW, Myerburg MM, Weiner DJ, Markovetz MR, et al · · 2016 · cited 22× · PMID 27009167 · DOI 10.1183/13993003.01880-2015 -
Multiprobe Nuclear Imaging of the Cystic Fibrosis Lung as a Biomarker of Therapeutic Effect.
Corcoran TE, Huber AS, Myerburg MM, Weiner DJ, et al · · 2019 · cited 4× · PMID 30969149 · DOI 10.1089/jamp.2018.1491
Verify or expand the search:
- PubMed search for NCT01887197
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Cystic Fibrosis
Currently open trials in the same condition.
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- NCT07283770 — Dose Escalation Study Evaluating the Safety and Pharmacokinetics of VX-581 in Healthy Participants · Phase 1 · recruiting
- NCT07274631 — A Cohort for Inflammatory Respiratory Diseases: From Phenotyping to Personalised Medicine · recruiting
- NCT06810167 — Assessing Tenapanor as a Treatment of CF-related Constipation. · Phase 3 · recruiting
- NCT06962852 — A Long-term Study to Monitor the Health Status of People With Cystic Fibrosis Who Took Part in a Previous Study With BI · Phase 1, PHASE2 · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01887197 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Tim Corcoran
- Last refreshed: 2 November 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01887197.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing