Contact information
Type
Scientific
Primary contact
Prof Henry Chrystyn
ORCID ID
Contact details
School of Pharmacy
University of Bradford
Bradford
BD7 1DP
United Kingdom
+44 (0)1274 233495
h.chrystyn@bradford.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0626168608
Study information
Scientific title
Acronym
Study hypothesis
Does an inhalation training aid designed for those using a Metered Dose Inhaler (MDI) maintain the correct inhalation technique after a patient has received training/counselling?
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Quality of life
Patient information sheet
Condition
Respiratory: Asthma
Intervention
Patients will have their inhalation technique assessed whilst inhaling from a placebo inhaler. Those with a good technique will be placed in the control group. Those with a poor technique will form the intervention group. Subjects in the intervention group will be randomised into a group that receives verbal counselling on how to use their MDI and a group that also receives the verbal counselling with the addition of the Two Tone Training Aid.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Changes in inspiratory flow rates through MDIs.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/03/2005
Overall trial end date
01/03/2006
Reason abandoned
Eligibility
Participant inclusion criteria
1. Asthma
2. Patients using at least one MDI without a spacer device
Prescribed a preventer inhaler
3. Age 3-65 - Group 1: 3-6 years, Group 2: 7-17 years, Group 3: 16 to 65 years
4. Written signed consent
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
120 patients will be recruited aged <17 and 17-65 years (40 participants in each of the three groups).
Participant exclusion criteria
1. Patients experiencing an acute exacerbation of asthma or receiving oral prednisolone in the four weeks prior to recruitment
2. Patients with other illnesses adversely affecting the respiratory system or evidence of fixed respiratory obstruction
3. Deaf or unable to distinguish between one and two tones with the Two-Tone trainer
4. Chronic obstructive pulmonary disease (COPD)
Recruitment start date
01/03/2005
Recruitment end date
01/03/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
School of Pharmacy
Bradford
BD7 1DP
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Bradford South and West Primary Care Trust (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
2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17400675
Publication citations
-
Results
Al-Showair RA, Pearson SB, Chrystyn H, The potential of a 2Tone Trainer to help patients use their metered-dose inhalers., Chest, 2007, 131, 6, 1776-1782, doi: 10.1378/chest.06-2765.