Randomised double-blind comparison of hand-held inhalers versus electric compressors and nebulisers, for domiciliary high-dose bronchodilator treatment in severe stable chronic obstructive pulmonary disease (COPD)

ISRCTN	ISRCTN36776916
DOI	https://doi.org/10.1186/ISRCTN36776916
Secondary identifying numbers	ND0020 T331

Submission date: 23/01/2004
Registration date: 23/01/2004
Last edited: 23/10/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Kate Hill
Scientific

Academic Unit of Psychiatry and Behavioural Sciences
15 Hyde Terrace
Leeds
LS2 9LT
United Kingdom

Phone	+44 (0)113 243 2704
Email	abc@email.com

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Scientific title	Randomised double-blind comparison of hand-held inhalers versus electric compressors and nebulisers, for domiciliary high-dose bronchodilator treatment in severe stable chronic obstructive pulmonary disease (COPD)
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Chronic obstructive pulmonary disease
Intervention	Current nebuliser treatment versus hand-held treatment versus new-generation nebuliser treatment
Intervention type	Other
Primary outcome measure	Quality of life measured by SGRQ (St George's Respiratory Questionnaire)
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/01/1995
Completion date	31/03/1995

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Both
Target number of participants	Not provided at time of registration
Key inclusion criteria	Patients with COPD
Key exclusion criteria	Does not match inclusion criteria
Date of first enrolment	01/01/1995
Date of final enrolment	31/03/1995

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Academic Unit of Psychiatry and Behavioural Sciences

Leeds
LS2 9LT
United Kingdom

Sponsor information

NHS R&D Regional Programme Register - Department of Health (UK)
Government

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

Phone	+44 (0)20 7307 2622
Email	dhmail@doh.gsi.org.uk
Website	http://www.doh.gov.uk

Funders

Funder type

Government

NHS Executive Northern and Yorkshire (UK)

No information available

Results and Publications

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

Editorial Notes

23/10/2019: Proactive update review. No pubs found. Search options exhausted.