To assess the impact of Target Inhalation Mode (TIM) aerosol delivery on the treatment time with nebulised antibiotic therapy in children with Cystic Fibrosis

ISRCTN	ISRCTN65617839
DOI	https://doi.org/10.1186/ISRCTN65617839
Protocol serial number	09-02-RE
Sponsor	Alder Hey Children's NHS Foundation Trust (UK)
Funder	Alder Hey Children's Foundation Trust Endowment Fund (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Mrs Pamela McCormack
Scientific

Alder Hey Children's Hospital
Eaton Rd
Liverpool
L12 2AP
United Kingdom

Primary study design	Interventional
Study design	Pilot randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	A pilot randomised controlled trial to assess the impact of Target Inhalation Mode (TIM) aerosol delivery on the treatment time with nebulised antibiotic therapy in children with Cystic Fibrosis
Study acronym	TIM CF
Study objectives	With an Adaptive Aerosol Delivery (AAD) device, use of target inhalation mode (TIM) will reduce the length of treatment times for inhalation when compared with standard tidal breathing mode.
Ethics approval(s)	Liverpool paediatric ethics committee and date of approval was 25/05/2009
Health condition(s) or problem(s) studied	Cystic Fibrosis
Intervention	Target inhalation mode vs tidal breathing mode for delivering aerosolised antibiotic through an adaptive aerosol delivery device
Intervention type	Other
Primary outcome measure(s)	Treatment time (seconds)
Key secondary outcome measure(s)	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
Completion date	31/05/2010

Participant type(s)	Patient
Age group	Child
Sex	All
Target sample size at registration	20
Key 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
Key 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
Date of first enrolment	01/06/2009
Date of final enrolment	31/05/2010

Alder Hey Children's Hospital

Liverpool
L12 2AP
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/09/2011		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes