Condition category
Respiratory
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
12/02/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Kate Hill

ORCID ID

Contact details

Academic Unit of Psychiatry and Behavioural Sciences
15 Hyde Terrace
Leeds
LS2 9LT
United Kingdom
+44 (0)113 243 2704

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 measures

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

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

http://www.doh.gov.uk

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes