Table 1.
Baseline Demographics and Characteristics of the Patients Included in the Systematic Review of Pharmacological Trials Lasting 12 Months or Longer in Patients with COPD
| (1997–2003) BRONCUS* Ref 16 |
(1992–1998) ISOLDE* Ref 6 |
(2000–2005) TORCH* Refs 10 and 18 |
(2003–2008) UPLIFT* Ref 11 |
(1986–1994) Lung Health I* Ref 3 | (2011–2015) Zhou et al.* Ref 19 | (2011–2015) SUMMIT* Refs 12 and 20 |
(1992–1994) Copenhagen City Lung Study* Ref 17 | (1994–1999) Lung Health Triamcinolone* Ref 21 | |
|---|---|---|---|---|---|---|---|---|---|
| Treatment arms: placebo/active intervention(s) | Placebo/N-acetylcysteine | Placebo/fluticasone propionate | Placebo/salmeterol/fluticasone propionate/salmeterol + fluticasone propionate | Placebo/tiotropium | Placebo/ipratropium bromide | Placebo/tiotropium | Placebo/fluticasone furoate/vilanterol/fluticasone furoate + vilanterol | Placebo/budesonide | Placebo/triamcinolone acetonide |
| Number of participants in study (and in RoD analysis, if different), (total) placebo/total active intervention | (523) 267/256 | (751) 375/376InRoD analysis: (664) 325/339 | (6,184) 1,545/4,639InRoD analysis: (5,343) 1,261/4,082 | (5,992) 3,006/2,986InRoD analysis: (4,964) 2,410/2,554 | (3,923) 1,962/1,961 | (771) 383/388 | (16,485) 4,111/12,374InRoD analysis: (15,457) 3,800/11,657 | (290) 145/145 | (1,116) 557/559 |
| Age, mean, yr | 62 | 64 | 65 | 65 | 48 | 64 | 65 | 59 | 56 |
| Sex, F, n (%) | 110 (21) | 191 (25) | 1,263 (24) | 1,520 (25) | 2,186 (37) | 113 (15) | 4,196 (25) | 115 (40) | 412 (37) |
| Smoking status current, % | 46% | 38% | 44% | 30% | NA | 41% | 47% | 77% | 90% |
| Previous year exacerbation hx, yearly rate | Placebo: 2.5Active: 2.4 | NA | 0: 43% | NA | NA | NA | 0: 61% | NA | NA |
| 1: 25% | 1: 24% | ||||||||
| ≥2: 32% | ≥2: 15% | ||||||||
| FEV1, mean, L† | 1.65 | 1.41 | 1.24 | 1.3 | 2.75 | 1.9 | 1.7 | 2.4 | 2.3 |
| FEV1, mean, % predicted | 57 | 50 | 45 | 48 | 75 | 78 | 60 | 87 | 68 |
| Study duration | 3 yr | 3 yr | 3 yr | 4 yr | 5 yr | 2 yr | 1.8 yr‡ | 3 yr | 40 mo§ |
| Number of spirometric assessments | 13 | 12 | 5 | 17 | 5 | 6 | 7‖ | 12 | Every 6 mo¶ |
| Completion of the study placebo/total active intervention | 168/186 | 175/212 | 55%/63% | 1,648/1,887 | >94%** | 282/303 | 2,919/9,311 | 94/109 | 92% |
Definition of abbreviations: BRONCUS = Bronchitis Randomized on NAC Cost-Utility Study; COPD = chronic obstructive pulmonary disease; hx = history; ISOLDE = Inhaled Steroids in Obstructive Lung Disease in Europe; NA = not available; Ref = reference; RoD = rate of decline in FEV1; SUMMIT = Study to Understand Mortality and Morbidity; TORCH = Toward a Revolution in COPD Health; UPLIFT = Understanding Potential Long-Term Impacts on Function with Tiotropium.
Statements and numbers in bold reflect the active arms of the study.
Date is start of recruitment to study complete.
Post-bronchodilator FEV1 except for Lung Health I and Copenhagen City Lung Study.
Study was event-driven average treatment in years.
Variable follow-up.
15,457 contributed an average of seven post-bronchodilator assessments at 3-month intervals.
Every 6 months during follow-up.
Completed fifth year of spirometry.