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Report for Clinical Trial NCT03435939

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Anti-Inflammatory Therapy to Augment CFTR Rescue in CF Patients

The goal of this study is to execute a small clinical proof of concept trial: To examine the effects of losartan on mucociliary clearance (MCC) in patients not eligible for CFTR rescue therapies

NCT03435939 Cystic Fibrosis
MeSH:Cystic Fibrosis Fibrosis

1 Interventions

Name: Losartan

Description: 50 mg/day for 7 days followed by 100 mg/day for 12 weeks
Type: Drug
Group Labels: 1

losartan


Primary Outcomes

Description: Losartan (100 mg for >12 weeks) will improve MCC+CC clearance in CF patients not on CFTR augmentation therapy in % of baseline

Measure: Improvement of mucociliary clearance ( MCC) and cough clearance (CC)

Time: 12 weeks treatment

Secondary Outcomes

Description: forced expiratory volume at one second (FEV1) in %predicted

Measure: Improvement on pulmonary function tests (in %predicted)

Time: 12 weeks of treatment

Description: forced expiratory volume at one second (FEV1) in liters

Measure: Improvement on pulmonary function tests (in L)

Time: 12 weeks of treatment

Description: Changes in serum inflammatory markers (hsCRP, WBC including absolute neutrophil count, %PMNs, serum amyloid A or SAA, calprotectin, GM-CSF, TGF-β active and total)

Measure: Decrease of inflammatory markers

Time: 12 weeks

Description: Nasal cytokine changes (TGF-β1 active and total, TNF-α, IL-1β, IL-6, IL-8, IL-13, COX-2)

Measure: Nasal cytokine changes

Time: 12 weeks

Purpose: Other

Allocation: N/A

Single Group Assignment


There is one SNP

SNPs


1 G551D

The CFTR potentiator ivacaftor (Kalydeco™), approved by the FDA mainly for class III mutations especially G551D, improves ion transport (large decrease in sweat chloride), clinical outcome (increased FEV1 and weight, decreased exacerbations), and quality of life. --- G551D ---



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