Table 2.
Primary and Secondary Outcomes According to Randomized Group
| Outcome | Nicotine Patch n = 24 Mean ± SE [n] |
Placebo Patch n = 25 Mean ± SE [n] |
Difference (95% CI), P Value | Sex-Adjusted Difference (95% CI), P Value |
|---|---|---|---|---|
| FVC, La | ||||
| Week 26 | 3.40 ± 0.223 [n = 20] | 2.86 ± 0.219 [n = 20] | 0.54 (–0.07 to 1.16) .081 | 0.36 (–0.14 to 0.87) .158 |
| Baseline | 3.34 ± 0.220 [n = 24] | 2.93 ± 0.215 [n = 25] | ||
| Change from baseline | 0.07 ± 0.04 | –0.07 ± 0.04 | 0.14 (0.01 to 0.26) .015 | 0.14 (0.03 to 0.25) .015 |
| FEV1a | ||||
| Week 26 | 2.51 ± 0.167) [n = 20] | 2.20 ± 0.164 [n = 20] | 0.31 (–0.15 to 0.77) .190 | 0.18 (–0.21 to 0.56) .372 |
| Baseline | 2.47 ± 0.167 [n = 24] | 2.21 ± 0.164 [n = 25] | ||
| Change from baseline | 0.037 ± 0.020 | –0.0081 ± 0.020 | 0.05 (–0.01 to 0.10) .120 | 0.05 (–0.002 to 0.09) .061 |
| Lung texture score17a | ||||
| Week 26 | 60.38 ± 4.70 [n = 21] | 68.74 ± 4.65 [n = 21] | –8.36 (–21.32 to 4.61) .206 | –8.11 (–21.30 to 5.07) .228 |
| Baseline | 61.35 ± 4.72 [n = 24] | 66.19 ± 4.62 [n = 25] | ||
| Change from baseline | –0.97 ± 3.46 | 2.54 ± 3.45 | –3.51 (–13.10 to 6.07) .473 | –3.50 (–13.09 to 6.08) .474 |
| Fatigue Assessment Scale18ab | ||||
| Week 26 | 23.60 ± 1.55 [n = 18] | 25.86 ± 1.58 [n = 17] | –2.26 (–6.61 to 2.08) .307 | –1.66 (–5.64 to 2.32) .414 |
| Baseline | 26.42 ± 1.37 [n = 23] | 25.69 ± 1.37 [n = 23] | ||
| Change from baseline | –2.82 ± 1.46 | 0.171 ± 1.50 | –2.99 (–7.10 to 1.12) .154 | –2.93 (–7.02 to 1.17) .161 |
| Sarcoidosis Assessment Tool19ab | ||||
| Week 26 | 116.17 ± 4.82 [n = 14] | 118.30 ± 4.51 [n = 17] | –2.13 (–15.07 to 10.81) .757 | –1.85 (–13.93 to 10.23) .764 |
| Baseline | 121.92 ± 4.05 [n = 19] | 123.64 ± 3.90 [n = 21] | ||
| Change from baseline | –5.75 ± 3.91 | –5.34 ± 3.42 | –0.415 (–10.60 to 9.77) .936 | –0.91 (11.16 to 9.34) .862 |
| St. George’s Respiratory Questionnaire20a | ||||
| Week 26 | 35.15 ± 4.76 [n = 18] | 34.21 ± 4.52 [n = 19] | 0.94 (–11.93 to 13.82) .886 | 3.42 (–9.33 to 16.16) .599 |
| Baseline | 40.72 ± 4.14 [n = 21] | 40.99 ± 3.88 [n = 24] | ||
| Change from baseline | –5.57 ± 2.84 | –6.78 ± 2.76 | 1.21 (–6.56 to 8.97) .761 | 1.09 (–6.71 to 8.88) .785 |
| Serum cotininea | ||||
| Week 26 | 136.64 ± 28.31 [n = 19] | 23.84 ± 28.03 [n = 19] | 112.80 (34.71 to 190.90) .005 | 111.44 (32.07 to 190.81) .006 |
| Baseline | 39.92 ± 20.70 [n = 24] | 33.68 ± 20.28 [n = 25] | ||
| Change from baseline | 96.72 ± 20.26 | –9.84 ± 20.26 | 106.56 (50.40 to 162.72) < .001 | 106.62 (50.44 to 162.79) < .001 |
a
Estimates obtained from a linear mixed effects model that accounted for correlation within participants over time, and when applicable in repeated measurements at each time point (FVC). Longitudinal models included an indicator variable for randomized treatment and a categorical variable for time point as main effects, as well as their interaction term.
b
Only participants with all non-missing scale components were included.