Short versus conventional term glucocorticoid therapy in acute exacerbations of chronic obstructive pulmonary disease: the REDUCE trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN19646069

Enrollment

390

Registered

2006-03-08

Start date

2006-02-27

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Exacerbation of Chronic Obstructive Pulmonary Disease (AECOPD) Respiratory Chronic obstructive pulmonary disease

Interventions

Comparison of 5-day to 14-day systemic glucocorticoid therapy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Clinical diagnosis of exacerbated COPD, defined by the presence of at least two of the following: a. Change in baseline dyspnoea b. Cough c. Sputum (levels I ? III according to American Thoracic Society [ATS] or European Respiratory Society [ERS] criteria) 2. Age =40 years 3. History of =20 pack-years of cigarette smoking

Exclusion criteria

Exclusion criteria: 1. Inability to give informed consent 2. Diagnosis of asthma 3. Forced expiratory volume in one second (FEV1) or Forced Vital Capacities (FVC) (Tiffenau) >70% (bedside post-bronchodilator) 4. Radiological diagnosis of pneumonia 5. Coexisting disease making survival of >6 months unlikely 6. Pregnancy or lactation (pregnancy test mandatory for pre-menopausal women)

Design outcomes

Primary

Measure	Time frame
Time to next COPD exacerbation	—

Secondary

Measure	Time frame
1. Cumulative steroid dose 2. Time to open-label standard-dose glucocorticoid therapy during the index exacerbation 3. Need for invasive or non-invasive mechanical ventilation 4. Change in FEV1 5. Clinical outcome at discharge and during follow-up as assessed by a standardized worksheet and questionnaire. Dyspnoea will be assessed according to the ATS consensus statement. 6. Duration of hospital stay 7. Death from any cause 8. Steroid-associated side-effects and complications: a. Development or exacerbation of hyperglycemia (defined as fasting plasma glucose =5.6mmol/l or random plasma glucose =7.8 mmol/l or rise by =20% in daily doses of insulin or oral anti-diabetic drugs or initiation of one or more anti-diabetic therapeutic principle) respectively b. Development or worsening of hypertension (defined as blood pressure =140 mmHg systolic and/or =90 mmHg diastolic; or the addition of one or more antihypertensive drugs to previous treatment regimens c. Suppression of the adrenal function at study entry and during follow-up as assessed with the low dose (1 ug) adrenocorticotropic hormone (ACTH) stimulation test d. Secondary infections e. Effects on bone turnover, assessed by specific biochemical markers (endpoint updated in April 2006) f. Other potential steroid-related adverse events (e.g. gastrointestinal bleeding or psychiatric disease)	—

Measure

Time frame

1. Cumulative steroid dose 2. Time to open-label standard-dose glucocorticoid therapy during the index exacerbation 3. Need for invasive or non-invasive mechanical ventilation 4. Change in FEV1 5. Clinical outcome at discharge and during follow-up as assessed by a standardized worksheet and questionnaire. Dyspnoea will be assessed according to the ATS consensus statement. 6. Duration of hospital stay 7. Death from any cause 8. Steroid-associated side-effects and complications: a. Development or exacerbation of hyperglycemia (defined as fasting plasma glucose =5.6mmol/l or random plasma glucose =7.8 mmol/l or rise by =20% in daily doses of insulin or oral anti-diabetic drugs or initiation of one or more anti-diabetic therapeutic principle) respectively b. Development or worsening of hypertension (defined as blood pressure =140 mmHg systolic and/or =90 mmHg diastolic; or the addition of one or more antihypertensive drugs to previous treatment regimens c. Suppression of the adrenal function at study entry and during follow-up as assessed with the low dose (1 ug) adrenocorticotropic hormone (ACTH) stimulation test d. Secondary infections e. Effects on bone turnover, assessed by specific biochemical markers (endpoint updated in April 2006) f. Other potential steroid-related adverse events (e.g. gastrointestinal bleeding or psychiatric disease)

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Countries

Switzerland

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 23, 2026