A phase II trial to assess the activity and tolerability of Thymosin alpha 1 in Cystic Fibrosis Patients

Conditions

Cystic Fibrosis

Brief summary

The activity of Thymosin alpha 1 will be evaluated by means of variation of inflammatory cytokines (IL-1ß, IL-8, IL-17A, IL-6 and TNF-alpha) in sputum.

Detailed description

Safety and tolerability will be evaluated during the course of the study by means of: - Type, incidence, severity, timing, seriousness and relatedness of reported AEs. - Physical examinations. - Vital signs. - ECGs. - Clinical laboratory results (local lab)., Activity will be evaluated during the course of the study by monitoring: - variation of a combined score of inflammatory cytokines; - variation of neutrophil elastase in sputum; - variation of blood C-reactive protein; - variation of the sweat chloride concentration tests., Efficacy will be evaluated by monitoring during the course of the study of: - change in predicted forced expiratory volume in 1 second (ppFEV1). - change in quality of life measured by CFQ-R questionnaire

Related papers

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Interventions

DRUGZADAXIN® 1

DRUG6 mg/ml

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The activity of Thymosin alpha 1 will be evaluated by means of variation of inflammatory cytokines (IL-1ß, IL-8, IL-17A, IL-6 and TNF-alpha) in sputum.	—

Secondary

Measure	Time frame
Safety and tolerability will be evaluated during the course of the study by means of: - Type, incidence, severity, timing, seriousness and relatedness of reported AEs. - Physical examinations. - Vital signs. - ECGs. - Clinical laboratory results (local lab)., Activity will be evaluated during the course of the study by monitoring: - variation of a combined score of inflammatory cytokines; - variation of neutrophil elastase in sputum; - variation of blood C-reactive protein; - variation of the sweat chloride concentration tests., Efficacy will be evaluated by monitoring during the course of the study of: - change in predicted forced expiratory volume in 1 second (ppFEV1). - change in quality of life measured by CFQ-R questionnaire	—

Measure

Time frame

Safety and tolerability will be evaluated during the course of the study by means of: - Type, incidence, severity, timing, seriousness and relatedness of reported AEs. - Physical examinations. - Vital signs. - ECGs. - Clinical laboratory results (local lab)., Activity will be evaluated during the course of the study by monitoring: - variation of a combined score of inflammatory cytokines; - variation of neutrophil elastase in sputum; - variation of blood C-reactive protein; - variation of the sweat chloride concentration tests., Efficacy will be evaluated by monitoring during the course of the study of: - change in predicted forced expiratory volume in 1 second (ppFEV1). - change in quality of life measured by CFQ-R questionnaire

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Countries

Italy

Outcome results

None listed