Table 2.
Characteristics of Head-to-Head Studies of Fluticasone and Budesonide in COPD
| Study author | Study design | Study duration (weeks) | Number evaluable (n) | Pneumonia diagnosis | Pneumonia severity | Patient characteristics | Covariates |
|---|---|---|---|---|---|---|---|
| Lipson et al 2017 (FULFIL)14 | Clinical trial - RCT | ITT: 24 Extension: 52 |
24-week ITT: BU: 899 FL: 911 52-week extension study: BU: 220 FL: 210 |
Clinical | Not reported | Mean age (y): BU: 63.7 FL: 64.2 Male (%): 74 Current smoker (%): BU: 44 FL: 44 CV risk factors (%): BU: 67 FL: 66 Moderate/severe COPD exacerbations in past 12 months (%): 0 exacerbations (%) BU: 35 FL: 34 1 exacerbation (%) BU: 28 FL: 28 ≥2 exacerbations (%) BU: 37 FL: 38 History of pneumonia (%): BU: 11 FL: 10 |
Randomization balanced for age, sex, smokers, CV risk factors, COPD exacerbation, history of pneumonia, FEV1 |
| Hirano et al 201820 | Observational - case-control | Variable; exposures stratified by 0-1, 1-2, 2-3, and >3 y | 252 ICS users (BU: 30, FL: 193) versus 387 non-ICS users |
Clinical; Medical records; Medical imaging |
Not reported | Median age (y): 75 Male (%): 83.7 Not reported |
Smoking history, oral steroid administration, oxygen therapy, inoculation with a pneumococcus vaccine, serum albumin levels, and body mass index |
| Yang et al 201716 | Observational - database/EMR/retrospective cohort | Variable; follow-up from index until December 31, 2010 or the end of treatment, emigration, or death | BU: 7295 FL: 7295(propensity score matched) |
ICD medical coding | All pneumonia events required emergency department or hospital admission. A hospitalization subgroup was defined for mechanically ventilated patients | Mean age (y): BU: 63.53 FL: 63.66 Male (%): BU: 73.47 FL: 73.83 Not reported |
Propensity score matching variables: age; sex; number of prescriptions for antibiotics, oral steroids, ICS, long-acting and short-acting bronchodilators; diagnosis of diabetes, cancer, heart failure, hypertension, stroke; and the number of previous severe COPD exacerbations (COPD-related hospitalizations or emergency department visits) |
| Kern 201519 | Observational - database/EMR/retrospective cohort | 52-week follow-up | BU: 3697 FL: 3697 (propensity score matched) |
ICD medical coding;pneumonia was a secondary outcome in this study | Not reported | Mean age (y; matched): BU: 63.7 FL: 64.0 Male (%; matched): BU: 47.7 FL: 46.2 Pneumonia (%; matched): BU: 22.3 FL: 23.5 Prior asthma (%; matched): BU: 35.7 FL: 34.6 Hypertension (%; matched): BU: 69 FL: 68 Use of other respiratory medications was also similar |
Sum of inpatient hospital stays >5 days (yes vs. no), LTRA use (0, 1, ≥2), geographic region, peripheral vascular disease/atherosclerosis (yes vs. no), index prescribing physician specialty, and analogous pre-index variable (eg, when analyzing the number of COPD-related hospitalizations in the post-index period, the model controlled for the number of pre-index COPD-related hospitalizations) |
| Janson et al 2013 (PATHOS)17 | Observational - database/EMR/retrospective cohort | Not reported | BU: 2734 FL: 2734 |
Medical records; ICD medical coding |
Mortality related to pneumonia defined using ICD-10 coding; admission to hospital because of pneumonia; days in hospital because of pneumonia | Mean age (y; matched): 67.6 Male (%; matched): 47 Current smoker (%; matched): BU: 49 FL: 48 Baseline asthma (%; matched): BU: 39 FL: 38 Heart failure (%; matched): BU: 17.6 FL: 17.2 Ischemic heart disease (%; matched): BU: 10.8 FL: 10.9 Diabetes (%; matched): BU: 10 FL: 11 |
Age; sex; available lung function measurements; number of prescriptions for antibiotics, oral steroids, tiotropium, ipratropium, ICS, SABA, LABA, angiotensin receptor blockers, β blockers, statins, calcium antagonists, and thiazides; diagnosis of diabetes, asthma, cancer, rheumatoid arthritis, heart failure, hypertension, and stroke; and number of previous admissions to hospital |
| Roberts et al 201118 | Observational - database/EMR/retrospective cohort | Continuous health coverage for 6 months before and 3 to 6 months after the index date |
BU: 3385 FL: 3385 (propensity score matched) |
ICD medical coding | Not measured | Male (%): BU: 44.3 FL: 43.9 Matched for age, sex, geography, pre-index comorbidities, pre-index health care utilization for COPD and pneumonia, respiratory medication use, and follow-up time |
A propensity score was calculated as probability of being in the BU combination group using a logistic regression controlling for demographics (age, sex, region),year of the index date, number of follow-up months, comorbid conditions, baseline medical services, and COPD-related pharmacy utilization |
Abbreviations: BU, budesonide; COPD, chronic obstructive pulmonary disease; CV, cardiovascular; EMR, electronic medical record; FEV1, forced expiratory volume in 1 second; FL, fluticasone; ICD, International Classification of Diseases; ICS, inhaled corticosteroid; ITT, intent to treat; LABA, long-acting β2-agonist; LAMA, long-acting muscarinic antagonist; LTRA, leukotriene receptor antagonist; RCT, randomized controlled trial; SABA, short-acting β2 agonist; SD, standard deviation.