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

The changes in sputum and plasma proteome in response to CFTR therapy

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN72529591

Enrollment

100

Registered

2022-03-02

Start date

2020-09-01

Completion date

Unknown

Last updated

2024-05-13

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

Conditions

Cystic fibrosis Nutritional, Metabolic, Endocrine

Interventions

We are using sputum and blood samples provided to a research biobank by cystic fibrosis patients commencing the drug Kaftrio. All patients have provided consent. These samples will be analysed by mass

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Cystic fibrosis patients commenced on the CFTR modulator Kaftrio

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Longitudinal change in sputum and plasma proteome associated with therapy (univariate and multivariate analyses). The proteome will be measured using mass spectrometry.	—

Secondary

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

Countries

England, United Kingdom

Outcome results

None listed

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