The use of an inhaled antibiotic called Cayston to treat acute chest infections in people with CF

Phase 1

Conditions: Cystic fibrosis
MedDRA version: 19.0Level: PTClassification code 10011762Term: Cystic fibrosisSystem Organ Class: 10010331 - Congenital, familial and genetic disorders
Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Registration Number: EUCTR2016-002832-34-GB

Lead Sponsor: iverpool Heart & Chest Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 16

Inclusion Criteria

Confirmed diagnosis of CF

Patients aged 18 - 65 years of age who have given informed consent

FEV1 >25% or <75% predicted (in keeping with Cayston® prescribing license)

Admitted to the Liverpool Heart and Chest Hospital with an exacerbation of CF pulmonary disease (as per modified Fuchs criteria)

Presence of Psa in lower respiratory tract cultures in the 6 months prior to screening

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 16
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

Documented allergy to beta-lactam antibiotics or IV Colistin

Growth of Burkholderia Cepacia Complex (BCC) within 2 years

Pregnancy

Previous organ transplant

Receiving other clinical trial medication

Already prescribed regular Cayston®

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Is using Cayston plus one standard intravenous antibiotic as effective as two standard intravenous antibiotics in the treatment of an acute chest infections in people with cystic fibrosis?;Secondary Objective: What changes occur in the bacterial community in the lung during treatment with Cayston plus an intravenous antibiotic and how do they compare to the changes seen when treatment is two intravenous antibiotics? ;Primary end point(s): Average actual change from Day 0 (start of exacerbation) in forced expiratory volume in 1 second (FEV1) % predicted;Timepoint(s) of evaluation of this end point: At 7 days, the end of each arm of study (day 14) and at 14 days post treatment (day 28)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Time to first protocol-defined pulmonary exacerbation (or end point of 12 months if no subsequent exacerbation)<br><br>Rate of hospitalizations for a respiratory event (12 months)<br><br>Average change from baseline in the Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Symptom Scale (RSS) score at the end of each arm of study (Day 14)<br><br>Psa sputum counts, total bacterial load and 16S microbiome (From sputum taken at Day 0 and Day 14 in each arm of the study)<br><br>Prevalence of resistance to antibiotics and changes in antimicrobial resistance ( From sputum taken at Day and Day 14 in each arm of the study) <br>;Timepoint(s) of evaluation of this end point: As above