The effect on blood and sputum measures of a new drug used to treat cystic fibrosis patients

Not Applicable

Completed

• Conditions: Cystic fibrosis; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN72529591
• Lead Sponsor: Manchester University NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-02
• Study Completion: 2023-06-01
• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 97

Inclusion Criteria

Cystic fibrosis patients commenced on the CFTR modulator Kaftrio

Exclusion Criteria

Any factor that would be expected to significantly influence the proteome in its own right, including conditions requiring immunosuppressive medication and immunodeficiency syndromes.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ongitudinal change in sputum and plasma proteome associated with therapy (univariate and multivariate analyses). The proteome will be measured using mass spectrometry.

Secondary Outcome Measures

Name	Time	Method
Comparison of proteome change and clinical response to therapy measured using biobank samples and patient records at a single time point