Cystic Fibrosis Trial, Recruiting NCT02270476 Sponsor: Heidelberg University Condition: Cystic Fibrosis
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Cystic Fibrosis Trial, Recruiting

NCT02270476
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who have been newly diagnosed with Cystic Fibrosis (CF), confirmed by at least one of three accepted methods: a sweat chloride test result of 60 or above, two CF-causing gene changes, or specific electrical measurements in the nose or rectum that are typical of CF.
  • Children diagnosed early (called "Early Diagnosed"): those identified with CF through newborn screening or for other reasons (such as family history, prenatal testing, or a bowel blockage at birth) within the first 4 months of life, with an original diagnosis date after January 1st, 2006.
  • Children diagnosed later (called "Late Diagnosed"): those identified with CF after 4 months of age due to symptoms showing up, with an original diagnosis date after January 1st, 2006.

Who may not be able to join:

  • Children or parents who do not wish to participate, or who have withdrawn from the study.
  • Cases where the CF diagnosis is uncertain.
  • Babies born before 30 weeks of pregnancy.
  • Children who required a longer period of breathing support through a machine (mechanical ventilation) in their first 3 months of life.
  • Children who have a significant health condition other than CF that could affect their ability to complete the full study.
  • Children who have had major surgery before joining, except surgery related to a bowel blockage (meconium ileus) or bowel narrowing at birth.
  • Children who have a major problem with an organ other than those already affected by CF (such as the pancreas or liver).
  • Children with physical findings that the study doctor believes would affect their safety or the quality of the study results.
  • Children who have a long-term lung condition other than CF, such as a condition called bronchopulmonary dysplasia.
  • Children who have had a bad reaction to sedation medication in the past, or who are known to have claustrophobia (fear of enclosed spaces).
  • Note: Some study procedures involving sedation may be delayed — rather than the child being excluded entirely — if the child has a significant airway blockage (such as severely floppy airways, very enlarged tonsils, heavy snoring, or diagnosed sleep apnoea), or has severe and persistent vomiting related to reflux that does not improve with treatment (confirm with trial site).

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 26 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Marcus A Mall, MD, University Hospital Heidelberg

Phone: +49 6221 56 4502

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Heidelberg University
Registry
ClinicalTrials.gov
Start date
1 December 2011
Est. completion
1 December 2030

Where this trial is recruiting

🇩🇪 Germany

Primary endpoints

Proportion with morphological and/or perfusion changes due to CF lung disease after chest MRI score in both groups; Proportion of patients with impairments in pulmonary function tests (e.g. multiple breath washout (MBW)) in both groups

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov