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Evaluation of treatment regimes in patients with cystic fibrosis and pulmonary excerbations (PEx)

Evaluation of treatment regimes in patients with cystic fibrosis and pulmonary excerbations (PEx) - EvPEx

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00012924
Enrollment
100
Registered
2017-09-22
Start date
2016-09-01
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

E84.0

Interventions

Group 1: CF Patients with an acute pulmonary exacerbation will be included in the study on the first day (d0) of antibiotic treatment. In-patients and out-patients are recruited in equal parts. The fo
d14, d21). After 4 weeks (d28) all investigations from d0 (see above) will be repeated once again in a final examination.

Sponsors

Klinik für Pädiatrie m. S. Pneumologie und ImmunologieCampus Rudolf Virchow Klinikum
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 75 Years

Inclusion criteria

Inclusion criteria: Included in the study are: 1. Patients with CF and acute pulmonary exacerbation (= 2/6 points in clinical symptome score) 2. Patients aged = 6 and = 75 3. Competent patients who have signed the written informed consens 4. Patients able to perform a lung function

Exclusion criteria

Exclusion criteria: Not included in the study are: 1. Patients who have undergone a lung transplantation 2. Patients aged 75 3. Incapacitated patients or patients who have not signed the written informed consens 4. Patients unable to perform a lung function

Design outcomes

Primary

MeasureTime frame
Lung function measurements (specifically: FEV1 measurement) on day 0, day 7, day 14, day 21 and day 28 by using a small FEV1 measurement gauge.

Secondary

MeasureTime frame
- Quality of life using a HRQL-questionnaire, peformed on day 0 and day 28 - Inflammatory markes such as CRP and leukocyten from a blood sample - Duration of antibiotic therapy - BMI on day 0 and day 28

Countries

Germany

Contacts

Public ContactCarsten Schwarz

Klinik für Pädiatrie m. S. Pneumologie und ImmunologieCampus Rudolf Virchow Klinikum

carsten.schwarz@charite.de030 450 666 576

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 9, 2026