Tumour necrosis factor-alpha (TNF-alpha) antagonists for acute exacerbations of chronic obstructive pulmonary disease (COPD)

Not Applicable

Completed

• Conditions: Chronic obstructive pulmonary disease (COPD); Respiratory; Other chronic obstructive pulmonary disease

• Registration Number: ISRCTN60472167
• Lead Sponsor: Ottawa Hospital Research Institute (OHRI) (Canada)

Brief Summary

2013 results in: https://www.ncbi.nlm.nih.gov/pubmed/23161645 [added 20/02/2019]

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-01-19
• Study Completion: 2011-01-01
• Last Update Posted: 18 March 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Both inpatients and outpatients with acute COPD exacerbation will be selected for randomisation. Patients will be considered to fulfill the diagnosis of AECOPD if they meet the following five criteria:
1. Patients must have had a previous diagnosis of chronic bronchitis, emphysema or COPD established by a physician
2. Patients must have evidence of airflow obstruction on presentation, defined as a forced expiratory volume in one second (FEV1) equal to or less than 70% of predicted and a FEV1/forced vital capacity (FVC) ratio less 70%
3. Patients must be greater than 35 years old, either sex
4. Patients must have a minimum history of 10 pack years smoking
5. Patients must be experiencing an acute exacerbation of COPD and must meet at least two of the following three clinical criteria for acute COPD exacerbation as defined by Anthonisen:
5.1. Increased chronic baseline dyspnoea
5.2. Increased sputum volume
5.3. Increased sputum purulence
The above complaints had to have necessitated the emergency department or physician visit.

Exclusion Criteria

1. Respiratory failure necessitating admission to an intensive care unit or necessitating use of mechanical invasive or non-invasive (bilevel positive airway pressure [BIPAP]) mechanical ventilation
2. Physician diagnosed asthma
3. Any patient who has used oral or injectable corticosteroids during the month preceding trial entry will be excluded, except for patients who have received a single dose of oral or injectable steroids (up to the equivalent of 125 mg of methylprednisolone) in the emergency department prior to randomisation. (Note that standard clinical practice in emergency departments is to treat these patients with oral or intravenous steroids on presentation to the ED. Since it will be functionally impossible to randomise patients prior to initial ED treatment we will allow randomisation of patients who have been given a single dose of steroid in the ED.)
4. History of chronic lung disease other than COPD. Patients with a history of bronchiectasis, cystic fibrosis, lung cancer and interstitial lung disease.
5. Pneumonia or congestive heart failure or suspected malignancy on chest x-ray (CXR) prior to randomisation
6. Patients with a history of infection, or suspected current infection, with mycobacteria tuberculosis, non-tuberculous mycobacteria, or fungal infection
7. Patients not able to perform an FEV1 assessment
8. Patients with known adverse reaction or intolerance to systemic steroids or TNF-alpha antagonists
9. Patients with a history of multiple sclerosis or demyelinating disease (etanercept is contraindicated in these patients)
10. Inability to provide informed consent or comply with the study protocol due to cognitive impairment, language barrier, or distance greater than 100 kilometres from the study centre
11. Patients with a history of human immunodeficiency virus (HIV) or other immuno-compromising diseases
12. Patients with a known malignancy within the past 5 years (except for squamous or basal cell carcinoma of the skin that was treated with no evidence of recurrence)
13. Patients who have serum white blood cell (WBC) count less than 3,000 or platelet count less than 100,000 at time of randomisation
14. Patients who are pregnant or nursing will be excluded. Females of child-bearing age will be required to have a negative serum or urine pregnancy test before randomisation.
15. Patients with suspected sepsis, i.e., those with temperature greater than 38.5°C or serum WBC greater than 20,000 will be excluded
16. Patients who have a history or active infection with viral hepatitis B or hepatitis C

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in lung function (FEV1) from day 0 to day 14

Secondary Outcome Measures

Name	Time	Method
<br> 1. Time to treatment failure assessed within a 90 day period<br> 2. Disease specific quality of life, measured at day 0, day 14, day 90<br> 3. Improvement in subjective dyspnoea score, measured at day 0, day 14, day 90<br> 4. Safety: incidence of short- and long-term adverse events from day 0 to day 90<br>