Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0436165615
Study information
Scientific title
Acronym
Study hypothesis
To counsel patients on the use of their inhaler technique and to see if this improves asthma related quality of life.
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
50 patients in each of the three groups:
1. Intervention counselled
2. Intervention non-counselled
3. Control group
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
1. Changes in inspiratory flow rates through MDIs
2. Changes in peak flow measurements
3. Scores from the asthma quality of life questionnaire (AQLQ)
4. Jones Morbidity Index score and answers to three questions on number of bottles of cough mixture, courses of antibiotics and number of prednisolone tablets taken in the past six months
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/05/2003
Overall trial end date
01/05/2004
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Not provided at time of registration
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
150
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/05/2003
Recruitment end date
01/05/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
School of Pharmacy
Bradford
BD5 0BB
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
Leeds Teaching Hospitals NHS 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
Basic results (scientific)
Publication list
2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17629471
Publication citations
-
Results
Al-Showair RA, Tarsin WY, Assi KH, Pearson SB, Chrystyn H, Can all patients with COPD use the correct inhalation flow with all inhalers and does training help?, Respir Med, 2007, 101, 11, 2395-2401, doi: 10.1016/j.rmed.2007.06.008.