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Table 1 Study Data for Trials Reporting Mean Change in Trough FEV1 and Patients Experiencing Any Exacerbation

From: The association of lung function and St. George's respiratory questionnaire with exacerbations in COPD: a systematic literature review and regression analysis

Author, Year

Treatment

Time point (weeks)

N Randomized

Definition of exacerbation

Annual exacerbation rate

N with any exacerbation

Comparison data for Time to first exacerbation (Hazard ratio)

Mean change in Trough FEV1 (L)

Comparison data for Trough FEV1 (treatment difference)

Bateman, 2010 [10]

Tiotropium 5 ug

48

1989

B+

0.12

685

Tio5 vs. Placebo: 0.69

0.119

--

Placebo

48

2002

0.15

842

 

0.018

--

Calverley, 2010 [12]

Beclomethasone/formoterol pMDI 400/24 μg

48

237

NR

0.074

64

--

0.077

B/F pMDI vs. F-DPI: 0.051

Budesonide/formoterol DPI)800/24 μg

48

242

0.033

64

--

0.08

B/F dry vs. F-DPI: 0.053

Formoterol DPI 12 μg

48

239

0.04

66

--

0.026

--

Chapman, 2011 [13]

Indacaterol, 150 μg

52

420

A

--

--

Ind150 vs. Placebo: 0.82

0.12

--

Indacaterol, 300 μg

52

418

--

--

Ind300 vs. Placebo: 0.86

0.13

--

Placebo

52

425

--

--

 

-0.04

--

Dahl, 2010 [14]

Indacaterol 300 μg

52

437

A

--

--

Inda300 vs. Placebo: 0.77

--

Inda300 vs. Placebo: 0.16

Indacaterol 600 μg

52

428

--

--

Inda600 vs. Placebo: 0.69

--

Inda600 vs. Placebo: 0.15

Formoterol

52

435

--

--

F vs. Placebo: 0.77

--

F vs. Placebo: 0.05

Placebo

52

432

--

--

 

--

--

Decramer, 2013 [15]

Tiotropium bromide 18 μg

26

1721

C

--

--

Tio18 vs. Inda150: 0.81

--

Tio18 vs. Inda150: 0.02

Indacaterol maleate 150 μg once-daily

26

1723

--

 

--

--

--

Tiotropium bromide 18 μg

52

1721

0.07

547

--

0.092

--

Indacaterol maleate 150 μg once-daily

52

1723

0.1

619

--

0.073

--

Dusser, 2006 [16]

Tiotropium 18 μg once daily

48

500

C

--

248

--

--

--

Placebo

48

510

--

305

--

--

Tio18 vs. Placebo: 0.12

Ferguson, 2008 [17]

Fluticasone propionate/salmeterol (FSC) 250/50

52

394

C

--

343

--

-0.012

--

Salmeterol 50 μg

52

388

--

335

--

-0.082

--

van Grunsven, 2003 [18]

Fluticasone propionate (Flixotides) 250 μg bid

103

24

D

--

5

--

-0.12

F250 vs. Placebo: 0.06

Placebo bid

103

24

--

3

--

-0.17

--

Vincken, 2002 [19]

Tiotropium 18 μg qd in the morning

52

356

B

--

125

--

0.12

--

Ipratropium 40 μg qid

52

179

--

82

--

-0.03

--

Wouters, 2005 [20]

Salmeterol/fluticasone (3 month run in period of salmeterol 50 μg and fluticasone 500 μg bid)

52

189

E

--

115

--

-0.04

S/F vs. S: 0.05

Salmeterol (3 month run in period of salmeterol 50 μg and fluticasone 500 μg bid)

52

184

--

109

--

-0.1

--

Zhou, 2006 [21]

Theophylline

52

57

C

--

26

--

0.0063

--

Placebo

52

53

--

30

--

-0.0533

--

Dransfield, 2013 [22]

Vilanterol 25 μg

52

409

A

--

203

--

-0.04

--

Fluticasone furoate 50 μg + Vilanterol 25 μg

52

408

--

190

--

0

--

Fluticasone furoate 100 μg + Vilanterol 25 μg

52

403

--

161

--

0.02

--

Fluticasone furoate 200 μg + Vilanterol 25 μg

52

402

--

178

--

0.02

--

Vilanterol 25 μg

52

409

--

197

--

-0.02

--

Fluticasone furoate 50 μg + Vilanterol 25 μg

52

412

--

198

--

0.02

--

Fluticasone furoate 100 μg + Vilanterol 25 μg

52

403

--

177

--

0.01

--

Fluticasone furoate 200 μg + Vilanterol 25 μg

52

409

--

160

--

0.01

--

  1. Exacerbation Definitions:
  2. A:Symptom deterioration requiring antibiotics, systemic corticosteroids, and/or hospitalization
  3. B:A complex of respiratory events lasting ≥3 days
  4. B+:A complex of respiratory events lasting ≥3 days requiring treatment
  5. C:Worsening of at least two symptoms for at least two days
  6. D:Having two of the following three symptoms: increased cough, wheezing and/or dyspnea; change in sputum color; use of bronchodilator rescue medication
  7. E:If a patient has in ≥2 consecutive days used ≥3 extra inhalations of salbutamol per 24 hours above their reference rescue value
  8. -- = Not Reported