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Spirometric Criteria for Chronic Obstructive Pulmonary Disease in Clinical Trials of Pharmacotherapy.
- Source :
-
COPD [COPD] 2018 Feb; Vol. 15 (1), pp. 17-20. - Publication Year :
- 2018
-
Abstract
- Clinical trials of pharmacotherapy in chronic obstructive pulmonary disease (COPD) often include older persons with moderate-to-severe airflow-obstruction, as defined by the Global Initiative for chronic Obstructive Lung Disease (GOLD). In this context, spirometric airflow-obstruction establishes COPD. Because GOLD misidentifies COPD and its severity in older persons, we set out to apply more age-appropriate spirometric criteria from the Global Lung function Initiative (GLI) in a prior clinical trial of COPD pharmacotherapy, specifically the Towards a Revolution in COPD Health (TORCH) trial - N = 6,112, mean age 65 years. In the TORCH trial, which enrolled GOLD-defined moderate COPD (26.2%, n = 1,200) and GOLD-defined severe COPD (73.8%, n = 4,511), the GLI reclassification yielded a higher frequency of severe COPD (89.6%, n = 5,474), the inclusion of restrictive-pattern (6.9%, n = 420) and, in turn, a very low frequency of moderate COPD (3.5%, n = 212). These GLI reclassification results suggest that GOLD-based enrollment criteria for the TORCH trial may have assembled a cohort that was: 1) less likely to respond to COPD pharmacotherapy, given the greater representation of severe COPD, very minor representation of moderate COPD, and inclusion of a non-obstructive spirometric impairment (restrictive-pattern); and 2) more likely to have medication-related adverse events, given the inappropriate use of COPD pharmacotherapy in misidentified COPD (restrictive-pattern). We therefore propose that future clinical trials of COPD pharmacotherapy should consider GLI criteria for defining COPD, including a greater representation of GLI-defined moderate COPD.
- Subjects :
- Age Factors
Aged
Bronchodilator Agents therapeutic use
Clinical Trials as Topic
Diagnostic Errors
Drug Therapy, Combination
Fluticasone therapeutic use
Forced Expiratory Volume
Humans
Middle Aged
Pulmonary Disease, Chronic Obstructive diagnosis
Pulmonary Disease, Chronic Obstructive drug therapy
Salmeterol Xinafoate therapeutic use
Severity of Illness Index
Vital Capacity
Pulmonary Disease, Chronic Obstructive classification
Pulmonary Disease, Chronic Obstructive physiopathology
Spirometry
Subjects
Details
- Language :
- English
- ISSN :
- 1541-2563
- Volume :
- 15
- Issue :
- 1
- Database :
- MEDLINE
- Journal :
- COPD
- Publication Type :
- Academic Journal
- Accession number :
- 29469677
- Full Text :
- https://doi.org/10.1080/15412555.2018.1424815