Insulin Therapy in Chronic Obstructive Pulmonary Disease (COPD) Exacerbations

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Influence of Insulin Therapy in Patients Admitted to Hospital With Acute Exacerbations of Chronic Obstructive Pulmonary Disease

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00467636
• Other study ID #: COPD1
• Status: Terminated
• Phase: N/A
• First received: April 27, 2007
• Last updated: October 1, 2009
• Start date: July 2007
• Est. completion date: May 2009

Study information

• Verified date: October 2009
• Source: The Royal Bournemouth Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the effect of preventing hyperglycaemia in patients admitted to hospital with acute exacerbations of chronic pulmonary disease.

Description:

Hyperglycaemia is associated with increased morbidity and mortality in patients admitted to hospital with acute critical illness, myocardial infarction and stroke. Moreover patients with hyperglycaemia have a significantly longer hospital stay, higher rates of ICU admission, increased in-hospital mortality and are more likely to require transfer to a nursing home. Recently, interventional studies have linked reversal of hyperglycaemia to better clinical outcomes especially in acute myocardial infarction, cardiac surgery and in critically ill patients.

In England and Wales, it is estimated that the number of people with COPD is approaching 1.5 million. The morbidity and economic costs associated with the condition are extremely high with approximately 10% of all acute medical admissions caused by exacerbations of the underlying condition. As a corollary about 15% of patients with COPD need admission to hospital each year.

Acute hyperglycaemia is common among patients admitted with acute exacerbations of COPD. The reasons for this are likely to be multi-factorial including an association between COPD and increased risk of developing diabetes at least in women, the elderly nature of the two populations and the use of glucocorticoids which markedly increases the risk of hyperglycaemia. Admission hyperglycaemia (>11 mmol/l) also appears to predict increased morbidity for patients with COPD admitted to intensive care.

The trial will be a randomised trial of comparison of usual treatment vs intensive insulin treatment for patients with COPD who may or may not have diabetes. Patients will take part in the trial for the first 5 days during their hospital stay.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 51
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion criteria

• Patients who are NOT diabetic, admitted with COPD who are likely to be prescribed corticosteroids as part of usual care with an admission glucose level (before steroids) between 6.1 and 11.1 mmol/l.

Exclusion criteria:

• Patients with diabetes mellitus

• Patients who are nil by mouth.

• Patients with severe co-morbid disease with an anticipated life expectancy of < 6 months.

• Patients who are unable to provide informed consent.

• Age <18 years.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Hyperglycemia
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Procedure:
• Blood glucose monitoring
Regular pre and post meal blood glucose monitoring.

Drug:
• Insulin Glulisine
Sub cutaneous injection given twice daily for 3 days. Dosage titrated to body mass index and body weight (BMI < 30 = 0.1 unit/kg. BMI > 30 = 0.2 unit/kg)

Locations

Country	Name	City	State
United Kingdom	Royal Bournemouth Hospital	Bournemouth	Dorset

Sponsors (2)

Lead Sponsor	Collaborator
The Royal Bournemouth Hospital	Sanofi

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of re-admission to hospital within 90 days.		90 days after discharged from hospital	No
Secondary	Length of stay		oct 2009	No
Secondary	In-patient mortality		look at cause death. for statistical purpose oct 2009	Yes
Secondary	Spirometry at baseline, day 3 and prior to discharge		oct 2009	No
Secondary	Achieved glucose levels		oct 2009	No
Secondary	Hypoglycaemic events (<4 mmol/l with or without symptoms)		instigate hypoglycaemia protocol at time. for statistical purpose oct 2009.	Yes
Secondary	Frequency of positive sputum cultures		oct 2009	No
Secondary	Change in CRP and IL-6 levels between baseline and day 5		oct 2009	No