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Efficacy and safety of Intra-erythrocytes dexamethasone in cystic fibrosis - ND

Efficacy and safety of Intra-erythrocytes dexamethasone in cystic fibrosis - ND

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2007-001782-15-IT
Enrollment
Unknown
Registered
2007-07-04
Start date
2008-04-09
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic Fibrosis MedDRA version: 9.1 Level: LLT Classification code 10011762 Term: Cystic fibrosis

Interventions

Product Name: dexamethasone Pharmaceutical Form: Solution for injection INN or Proposed INN: Dexamethasone Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 250-

Sponsors

ISTITUTO GIANNINA GASLINI
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patient with diagnosis of cystic fibrosis Age 6 >years Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Sputum positive for Mycobacteri reported membrane defects in erythrocytes and/or hemoglobin anomalies

Design outcomes

Primary

MeasureTime frame
Main Objective: Improvement or worsening lt; 2 of FEV1 in front of 18 months precedents the enrolnment;Secondary Objective: improvement of the nutritional status and reduction of the acute episodes of pulmonary infection;Primary end point(s): Improvement or worsening 2 of FEV1 in front of 18 months precedents the enrolnment—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026