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Long-acting inhaled anticholinergic therapy improves sleeping oxygen saturation in COPD

W.T. McNicholas, P.M.A. Calverley, A. Lee, J.C. Edwards on behalf of the Tiotropium Sleep Study in COPD Investigators
European Respiratory Journal 2004 23: 825-831; DOI: 10.1183/09031936.04.00085804
W.T. McNicholas
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P.M.A. Calverley
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A. Lee
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J.C. Edwards
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  • Article
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Figures

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  • Fig. 1.—
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    Fig. 1.—

    A flow chart of study assessments.

  • Fig. 2.—
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    Fig. 2.—

    The disposition of patients in the study.

Tables

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  • Table 1

    Demographics and baseline characteristics

    CharacteristicTiotropium-AMTiotropium-PMPlaceboTotal
    Total treated33323095
    Male sex n (%)22 (67)21 (66)23 (77)66 (70)
    Age yrs66.7 (48–77)65.1 (54–79)67.6 (49–82)66.4 (48–82)
    Weight kg70.6 (46–113)72.8 (40–100)70.5 (44–109)71.3 (40–113)
    Height cm166.8 (134–182)168.1 (140–192)169.2 (152–188)168.0 (134–192)
    Smoking history
     Current smoker n (%)12 (36)9 (28)9 (30)30 (32)
     Pack-yrs50.4 (10–186)46.5 (12–120)51.6 (10–130)49.5 (10–186)
    FEV1 L0.82±0.270.87±0.320.81±0.310.84±0.30
    FVC L1.89±0.622.01±0.801.95±0.621.95±0.68
    FEV1/FVC %45±1046±1443±1344±12
    FEV1 % predicted33±1233±1331±1232±12
    Pa,O2 mmHg66.0±6.964.1±6.863.5±7.864.6±7.2
    Low Pa,O2 stratum ≤65 mmHg n (%)13 (39.4)18 (56.3)15 (50.0)46 (48.4)
    High Pa,O2 stratum 66–75 mmHg n (%)20 (60.6)14 (43.8)15 (50.0)49 (51.6)
    • Data are presented as mean (range) or mean±sd unless otherwise stated

    • FEV1: forced expiratory volume in one second

    • FVC: forced vital capacity

    • Pa,O2: awake arterial oxygen tension

    • Total randomised patients: n=95. All patients were Caucasian

    • 1 mmHg=0.133 kPa

  • Table 2

    Oxygen saturation (%) during rapid eye movement (REM) sleep and differences between treatment groups at end of study

    ComparisonTiotropium-AMTiotropium-PMTiotropium pooledPlaceboDifference in % pointsp-value95% CI
    Subjects n19173611
    Tiotropium-AM versus placebo89.97 (0.59)87.56 (0.76)2.410.0160.48–4.33
    Tiotropium-PM versus placebo89.98 (0.62)87.562.420.0200.41–4.43
    Tiotropium pooled versus placebo89.98 (0.41)87.562.410.0080.68–4.15
    • Data are presented as mean (se) unless otherwise stated and are from the patient population with total sleep time of at least 2 h

    • Some patients did not have any REM sleep at baseline or end of study

    • Means are adjusted for baseline arterial oxygen saturation (Sa,O2) and arterial oxygen tension. Overall mean baseline Sa,O2 during REM sleep=88.74%

  • Table 3

    Oxygen saturation (%) during total sleep time and differences between treatment groups at end of study

    ComparisonTiotropium-AMTiotropium-PMTiotropium pooledPlaceboDifference in % pointsp-value95% CI
    Subjects n21183913
    Tiotropium-AM versus placebo89.83 (0.84)87.82 (1.05)2.010.141−0.69–4.71
    Tiotropium-PM versus placebo90.88 (0.92)87.823.060.0350.23–5.91
    Tiotropium pooled versus placebo90.31 (0.61)87.822.490.0470.02–4.93
    • Data are presented as mean (se) unless otherwise stated and are from the patient population with total sleep time of at least 2 h

    • Means are adjusted for baseline arterial oxygen saturation (Sa,O2) and arterial oxygen tension

    • Overall mean baseline Sa,O2 during total sleep time=89.58%

  • Table 4

    Effect of tiotropium (pooled AM and PM) versus placebo on duration of sleep stages, latency to persistent sleep and latency to rapid eye movement (REM) sleep

    StageOverall mean baselineTiotropiumPlaceboDifferencep-value
    Subjects n4016
    Awake120.3110.0 (9.8)120.3 (15.7)−10.30.585
    Stage I40.539.4 (4.9)50.8 (7.7)−11.40.219
    Stage II158.8168.1 (10.1)147.0 (16.1)21.10.275
    Stage III/IV40.435.2 (4.6)47.9 (7.3)−12.70.146
    REM37.852.1 (4.6)51.1 (7.4)1.00.906
    Total sleep time277.4294.4 (11.1)297.8 (17.6)−3.40.871
    Total sleep period397.7408.7 (12.0)408.2 (19.2)0.50.982
    Latency to persistent sleep30.832.2 (5.3)40.9 (8.0)−8.70.370
     Subjects n3616
    Latency to REM sleep120.497.5 (9.5)89.7 (17.0)7.80.695
     Subjects n3612
    • Data are presented as mean (SE) unless otherwise stated and are from the patient population with total sleep time of at least 2 h

    • Means are adjusted for baseline stage duration and baseline arterial oxygen tension

    • Latency to persistent sleep is the time in minutes to the first period of stage II sleep

  • Table 5

    Effect of tiotropium (pooled AM and PM) versus placebo on pre- and post-sleep forced expiratory volume in one second (FEV1) and forced vital capacity (FVC)

    TiotropiumPlaceboDifferencep-value95% CI
    Pre-sleep FEV1 L0.91 (0.03)0.72 (0.05)0.190.0020.07–0.31
     Patients n4015
    Post-sleep FEV1 L0.81 (0.02)0.64 (0.03)0.170.00010.09–0.26
     Patients n3816
    Pre-sleep FVC L2.18 (0.07)1.87 (0.12)0.310.0270.04–0.58
     Patients n4015
    Post-sleep FVC L1.94 (0.06)1.58 (0.09)0.360.0010.15–0.57
     Patients n3816
    • Data are presented as mean (se) from the patient population with total sleep time of at least 2 h (n=56)

    • Means are adjusted for end-point baseline and baseline arterial oxygen tension

    • Overall mean baseline FEV1: pre-sleep: 0.84 L

    • post-sleep: 0.76 L

    • Overall mean baseline FVC: pre-sleep: 2.03 L; post-sleep: 1.79 L

  • Table 6

    Correlation between mean oxygen saturation during rapid eye movement (REM) sleep and forced expiratory volume in one second (FEV1)

    Pearson correlation coefficientp-value
    Pre-sleep FEV1
     Baseline visit0.290.045
     End-of-treatment visit0.420.003
    Post-sleep FEV1
     Baseline visit0.280.064
     End-of-treatment visit0.360.013
    • Data are from patient population with total sleep time of at least 2 h who also had REM sleep (n=47)

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Long-acting inhaled anticholinergic therapy improves sleeping oxygen saturation in COPD
W.T. McNicholas, P.M.A. Calverley, A. Lee, J.C. Edwards
European Respiratory Journal Jun 2004, 23 (6) 825-831; DOI: 10.1183/09031936.04.00085804

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Long-acting inhaled anticholinergic therapy improves sleeping oxygen saturation in COPD
W.T. McNicholas, P.M.A. Calverley, A. Lee, J.C. Edwards
European Respiratory Journal Jun 2004, 23 (6) 825-831; DOI: 10.1183/09031936.04.00085804
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