Table 4. Night-time symptoms as secondary end-points in clinical trials of respiratory drugs for chronic obstructive pulmonary disease (COPD)
CitationStudy drugsNight-time symptoms end-pointRelevant results
Welte et al. [68] (2009)Tiotropium plus budesonide/formoterol versus tiotropium aloneDiary card including a five-point scale of sleep disturbanceTiotropium plus budesonide/formoterol improved awakening due to COPD
Terzano et al. [69] (2008)Tiotropium with and without formoterolDiary card of night-time reliever useEvening dosing of tiotropium offered the greatest reduction in night-time reliever use
Campbell et al. [70] (2005)Formoterol versus placeboDiary card including sleep disturbance and night-time reliever useSignificant reduction in sleep disturbance and night-time reliever use with active treatment
Welte et al. [71] (2008)FormoterolDiary card including a five-point scale of sleep disturbance based on the number and/or duration of awakenings and early awakeningsImprovement in sleep disturbance with active treatment
Tashkin et al. [72] (2009)Formoterol plus tiotropium versus tiotropium aloneDiary card of night-time awakenings and reliever useSignificantly greater decline in night-time
awakenings with the combination regimen
Rennard et al. [73] (2009)Budesonide plus formoterol versus formoterol aloneSleep score and per cent awakening-free nightsSignificant 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 inhalersDiary card including a five-point scale of sleep disturbance; awakening-free nightsImprovement in sleep score and awakening-free nights
Partridge et al. [74] (2009)Budesonide plus formoterol versus salmeterol plus fluticasoneE-diary card to record symptoms and basic morning activitiesPost-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 aloneDiary card of night-time awakeningsSignificant reduction in weekly night-time awakenings with combination regimen
Zheng et al. [75] (2007)Fluticasone plus salmeterol versus placeboDiary card of night-time awakeningsSignificantly higher percentage of days without night-time awakenings with active treatment
Make et al. [76] (2005)Fluticasone plus salmeterol versus placeboDiary card including a visual analogue scale of severity of sleep symptomsSignificantly greater improvement in symptom-free nights, awakenings, and sleep symptom scores with combination regimen