Condition category
Nutritional, Metabolic, Endocrine
Date applied
14/03/2011
Date assigned
07/04/2011
Last edited
17/01/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Pamela McCormack

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

09-02-RE

Study information

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

Acronym

TIM CF

Study hypothesis

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

Liverpool paediatric ethics committee and date of approval was 25/05/2009

Study design

Pilot randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Cystic Fibrosis

Intervention

Target inhalation mode vs tidal breathing mode for delivering aerosolised antibiotic through an adaptive aerosol delivery device

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/06/2009

Overall trial end date

31/05/2010

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

20

Participant 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

Recruitment start date

01/06/2009

Recruitment end date

31/05/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

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

Sponsor information

Organisation

Alder Hey Children's NHS Foundation Trust (UK)

Sponsor details

Eaton Rd
Liverpool
L12 2AP
United Kingdom

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

Alder Hey Children's Foundation Trust Endowment Fund (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21620782

Publication citations

  1. Results

    McCormack P, McNamara PS, Southern KW, A randomised controlled trial of breathing modes for adaptive aerosol delivery in children with cystic fibrosis., J. Cyst. Fibros., 2011, 10, 5, 343-349, doi: 10.1016/j.jcf.2011.04.006.

Additional files

Editorial Notes