Determine if counselling patients on how to use Metered Dose Inhalers improves quality of life

ISRCTN	ISRCTN69215680
DOI	https://doi.org/10.1186/ISRCTN69215680
Secondary identifying numbers	N0626168608

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Henry Chrystyn
Scientific

School of Pharmacy
University of Bradford
Bradford
BD7 1DP
United Kingdom

Phone	+44 (0)1274 233495
Email	h.chrystyn@bradford.ac.uk

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Quality of life
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure	Changes in inspiratory flow rates through MDIs.
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/03/2005
Completion date	01/03/2006

Participant type(s)	Patient
Age group	Adult
Sex	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).
Key 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
Key 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)
Date of first enrolment	01/03/2005
Date of final enrolment	01/03/2006

School of Pharmacy

Bradford
BD7 1DP
United Kingdom

Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government

The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom

Government

Bradford South and West Primary Care Trust (UK)

No information available

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

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/06/2007		Yes	No