Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
ND0020 T331
Study information
Scientific title
Acronym
Study hypothesis
Approximately 200,000 people in the Yorkshire Region have COPD of varying degrees of severity. A recent published regional review has shown that more than 2000 of the more severely disabled patients are currently treated at home with high dose bronchodilators using nebulisers and compressors. This represents a £20k capital cost, an approximate annual £20k servicing cost, and an annual drug bill of £2m. The regional review has shown that this expensive treatment is often introduced without adequate assessments. Hand-held inhalers may be more efficient and cheaper. Projected drug costs if hand held inhalers were used for the usual combination of bronchodilator drugs for such patients in equivalent doses would be approximately £700k per annum with a potential saving to the Health Authorities of more than a million pounds per annum.
Similarly, regular use of newer-generation nebulisers, which are more efficient, might result in a saving of half the drug costs, again without any compromise in patient benefit. Before purchasers can recommend either a trial of high dose hand-held inhalers or the use of newer-generation nebulisers to achieve these savings, it is necessary to show in a controlled double-blind study that patient benefit from equipotent doses in the three systems (current nebuliser treatment versus hand-held treatment versus new-generation nebuliser treatment) are equivalent. This study will provide evidence allowing purchasers to make such judgments. From the patients point of view, the benefit from using hand-held inhalers rather than electric compressors and nebulisers is that the treatment is less complex, taking 15 minutes per day rather than one hour per day to use and would allow people to travel, and not to rely on emergency back-up and service arrangements.
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
Other
Trial type
Treatment
Patient information sheet
Condition
Chronic obstructive pulmonary disease
Intervention
Current nebuliser treatment versus hand-held treatment versus new-generation nebuliser treatment
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Quality of life measured by SGRQ (St George's Respiratory Questionnaire)
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/1995
Overall trial end date
31/03/1995
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients with COPD
Participant type
Patient
Age group
Not Specified
Gender
Both
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Does not match inclusion criteria
Recruitment start date
01/01/1995
Recruitment end date
31/03/1995
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Academic Unit of Psychiatry and Behavioural Sciences
Leeds
LS2 9LT
United Kingdom
Sponsor information
Organisation
NHS R&D Regional Programme Register - Department of Health (UK)
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
NHS Executive Northern and Yorkshire (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