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 |
| Protocol serial number | ND0020 T331 |
| Sponsor | NHS R&D Regional Programme Register - Department of Health (UK) |
| Funder | NHS Executive Northern and Yorkshire (UK) |
- 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
Scientific
Academic Unit of Psychiatry and Behavioural Sciences
15 Hyde Terrace
Leeds
LS2 9LT
United Kingdom
| Phone | +44 (0)113 243 2704 |
|---|---|
| abc@email.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Quality of life measured by SGRQ (St George's Respiratory Questionnaire) |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/03/1995 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | All |
| 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
- United Kingdom
- England
Study participating centre
Academic Unit of Psychiatry and Behavioural Sciences
Leeds
LS2 9LT
United Kingdom
LS2 9LT
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
23/10/2019: Proactive update review. No pubs found. Search options exhausted.
