Cystic Fibrosis Nutritional, Metabolic, Endocrine Cystic fibrosis
Conditions
Interventions
Target inhalation mode vs tidal breathing mode for delivering aerosolised antibiotic through an adaptive aerosol delivery device
Sponsors
Alder Hey Children's NHS Foundation Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with a valid diagnosis (sweat chloride > 60 or two CF causing gene mutations) 2. Airway infection with Pseudomonas aeruginosa requiring long term nebulised Colistin therapy 3. Established on standard Tidal Breathing Mode of delivery using AAD device for Colistin therapy 4. Ability to comprehend use of the TIM device and follow instruction 5. Aged more than or equal to 5 years and able to perform lung function 6. No recent (> 6 weeks) exacerbation of chest condition as defined by 6.1. A deterioration forced expiratory volume in one second (FEV1) more than or equal to 10% from previously recorded value 6.2. Cough 6.3. Change in sputum production
Exclusion criteria
Exclusion criteria: 1. Patient with first growth of Pseudomonas aeruginosa requiring short term (3 months) colistin therapy 2. Patients prescribed alternate month TOBI and Colistin nebulised therapy 3. Patients with an acute exacerbation respiratory symptoms
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment time (seconds) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. % Adherence to treatment 2. Pseudomonas growth (number of colony forming units on respiratory culture) 3. Pulmonary function (FEV1 and forced vital capacity (FVC), percent predicted for age, sex and height) 4. Adverse events (e.g. wheeze, or increase in wheeze or change in wheeze pattern) 5. Patient withdrawal 6. Patient reported outcomes using Challenges of Living with Cystic Fibrosis (CLCF) questionnaire | — |
Countries
United Kingdom
Outcome results
None listed