NCT01619657 (PRESIS) is a Phase 2 clinical trial of 6% Hypertonic Saline (HS), 4mL in Cystic Fibrosis Lung Disease, sponsored by Heidelberg University.

Who is sponsoring NCT01619657?

NCT01619657 is sponsored by Heidelberg University.

What drugs are being tested in NCT01619657?

Interventions in NCT01619657: 6% Hypertonic Saline (HS), 4mL, 0.9% Isotonic Saline (IS), 4mL.

What condition does NCT01619657 study?

NCT01619657 studies Cystic Fibrosis Lung Disease.

Is NCT01619657 still recruiting?

NCT01619657 is currently completed. Last updated 25 October 2017.

Last reviewed 2017-10-25 · How we verify

NCT01619657: PRESIS

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Randomized, Double-blind, Controlled Pilot Study on Safety of Hypertonic Saline as Preventive Inhalation Therapy in Newborns and Infants With Cystic Fibrosis

Completed Phase 2 Last updated 25 October 2017

What this trial tests

Phase 2 trial testing 6% Hypertonic Saline (HS), 4mL in Cystic Fibrosis Lung Disease in 42 participants. Completed in 1 October 2017.

Timeline

1 June 2012

Primary endpoint
1 November 2016

1 October 2017

Quick facts

Lead sponsor	Heidelberg University
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	42
Start date	1 June 2012
Primary completion	1 November 2016
Estimated completion	1 October 2017
Sites	4 locations across Germany

Drugs / interventions tested

6% Hypertonic Saline (HS), 4mL — full drug profile →
0.9% Isotonic Saline (IS), 4mL — full drug profile →

Conditions studied

Cystic Fibrosis Lung Disease — all drugs for Cystic Fibrosis Lung Disease →

Sponsor

Heidelberg University

Who can join

Under 4 Months, any sex, with Cystic Fibrosis Lung Disease. 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.

Number of patients in both treatment groups with adverse events (AEs) and serious adverse events (SAEs)
Time frame: during the 52 week treatment period
Safety of inhalation with HS and IS in newborns and infants with CF assessed by proportion of adverse events (AEs) and serious adverse events (SAEs)

Sponsor's own description

The purpose of this study is to assess whether 6% hypertonic saline (HS) is a safe and effective preventive therapy in newborns and infants with cystic fibrosis (CF).

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

Preventive Inhalation of Hypertonic Saline in Infants with Cystic Fibrosis (PRESIS). A Randomized, Double-Blind, Controlled Study.
Stahl M, Wielpütz MO, Ricklefs I, Dopfer C, et al · · 2019 · cited 74× · PMID 30409023 · DOI 10.1164/rccm.201807-1203oc
Nebulised hypertonic saline for cystic fibrosis.
Wark P, McDonald VM. · · 2018 · cited 42× · PMID 30260472 · DOI 10.1002/14651858.cd001506.pub4
Update in Cystic Fibrosis 2018.
Ramsey BW, Downey GP, Goss CH. · · 2019 · cited 10× · PMID 30917288 · DOI 10.1164/rccm.201902-0310up
Nebulised hypertonic saline for cystic fibrosis.
Wark P, McDonald VM, Smith S. · · 2023 · cited 6× · PMID 37319354 · DOI 10.1002/14651858.cd001506.pub5

Verify or expand the search:

Other Heidelberg University trials

Trials by the same sponsor.

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NCT06852599 — Long-term Outcomes of Implants in Patients with Periodontitis · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01619657 (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 Heidelberg University
Last refreshed: 25 October 2017

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/NCT01619657.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing