Citation | Study drugs | Night-time symptoms end-point | Relevant results |
Welte et al. [68] (2009) | Tiotropium plus budesonide/formoterol versus tiotropium alone | Diary card including a five-point scale of sleep disturbance | Tiotropium plus budesonide/formoterol improved awakening due to COPD |
Terzano et al. [69] (2008) | Tiotropium with and without formoterol | Diary card of night-time reliever use | Evening dosing of tiotropium offered the greatest reduction in night-time reliever use |
Campbell et al. [70] (2005) | Formoterol versus placebo | Diary card including sleep disturbance and night-time reliever use | Significant reduction in sleep disturbance and night-time reliever use with active treatment |
Welte et al. [71] (2008) | Formoterol | Diary card including a five-point scale of sleep disturbance based on the number and/or duration of awakenings and early awakenings | Improvement in sleep disturbance with active treatment |
Tashkin et al. [72] (2009) | Formoterol plus tiotropium versus tiotropium alone | Diary card of night-time awakenings and reliever use | Significantly greater decline in night-time awakenings with the combination regimen |
Rennard et al. [73] (2009) | Budesonide plus formoterol versus formoterol alone | Sleep score and per cent awakening-free nights | Significant improvement in sleep score and per cent awakening-free nights with combination regimen |
Tashkin et al. [31] (2008) | Budesonide plus formoterol in a single inhaler versus separate inhalers | Diary card including a five-point scale of sleep disturbance; awakening-free nights | Improvement in sleep score and awakening-free nights |
Partridge et al. [74] (2009) | Budesonide plus formoterol versus salmeterol plus fluticasone | E-diary card to record symptoms and basic morning activities | Post-dose morning activity scores were significantly higher with budesonide plus formoterol after 1 week of dosing |
Anzueto et al. [30] (2009) | Fluticasone plus salmeterol versus salmeterol alone | Diary card of night-time awakenings | Significant reduction in weekly night-time awakenings with combination regimen |
Zheng et al. [75] (2007) | Fluticasone plus salmeterol versus placebo | Diary card of night-time awakenings | Significantly higher percentage of days without night-time awakenings with active treatment |
Make et al. [76] (2005) | Fluticasone plus salmeterol versus placebo | Diary card including a visual analogue scale of severity of sleep symptoms | Significantly greater improvement in symptom-free nights, awakenings, and sleep symptom scores with combination regimen |