deltatrials
Completed PHASE2 INTERVENTIONAL 2-arm NCT01619657

Preventive Inhalation of Hypertonic Saline in Infants With Cystic Fibrosis (PRESIS)

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

Sponsor: German Center for Lung Research

Conditions Cystic Fibrosis Lung Disease
Interventions 0.9% Isotonic Saline (IS), 4mL 6% Hypertonic Saline (HS), 4mL
Updated 8 times since 2017 Last updated: Oct 25, 2017 Started: Jun 30, 2012 Primary completion: Nov 30, 2016 Completion: Oct 31, 2017
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT01619657, this PHASE2 trial focuses on Cystic Fibrosis Lung Disease and remains completed. Sponsored by German Center for Lung Research, it has been updated 8 times since 2012, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

~Jan 2017 – ~Jun 2017 · 5 months · monthly snapshotActive Not Recruiting~Jun 2017 – ~Nov 2017 · 5 months · monthly snapshotActive Not Recruiting~Nov 2017 – ~Jun 2018 · 7 months · monthly snapshotCompleted~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotCompleted~Sep 2025 – present · 10 months · monthly snapshotCompleted

Change History

8 versions recorded

  1. Sep 2025 — Present [monthly]

    Completed PHASE2

  2. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE2

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE2

  4. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE2

  5. Jun 2018 — Jan 2021 [monthly]

    Completed PHASE2

▶ Show 3 earlier versions

  1. Nov 2017 — Jun 2018 [monthly]

    Completed PHASE2

    Status: Active Not Recruiting → Completed

  2. Jun 2017 — Nov 2017 [monthly]

    Active Not Recruiting PHASE2

  3. Jan 2017 — Jun 2017 [monthly]

    Active Not Recruiting PHASE2

    First recorded

Jun 2012

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • German Center for Lung Research
  • Heidelberg University
Data source: Heidelberg University

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations