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 |
| Secondary identifying numbers | 09-02-RE |
- Submission date
- 14/03/2011
- Registration date
- 07/04/2011
- Last edited
- 17/01/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mrs Pamela McCormack
Scientific
Scientific
Alder Hey Children's Hospital
Eaton Rd
Liverpool
L12 2AP
United Kingdom
Study information
| Study design | Pilot randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | Treatment time (seconds) |
| Secondary outcome measures | 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 |
| Overall study start date | 01/06/2009 |
| Completion date | 31/05/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | Both |
| Target number of participants | 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 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Alder Hey Children's Hospital
Liverpool
L12 2AP
United Kingdom
L12 2AP
United Kingdom
Sponsor information
Alder Hey Children's NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Eaton Rd
Liverpool
L12 2AP
England
United Kingdom
"ROR" |
https://ror.org/00p18zw56 |
|---|
Funders
Funder type
Government
Alder Hey Children's Foundation Trust Endowment Fund (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/09/2011 | Yes | No |
