Essential criteria for pharmacokinetic studies supporting bioequivalence of inhaled tiotropium bromide products

Sharma, Ashish; Weber, Benjamin; Wein, Martina; Hallmann, Christoph

doi:10.1002/cpdd.187

Cited by 4 publications

(1 citation statement)

References 19 publications

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“…Although non-invasive ventilator produces some benefits in the treatment of COPD-OSAHS, the use of non-invasive ventilator alone is not enough, especially with increase in the incidence of the disease. Therefore, there is need to explore new ways to treat this disease [5][6][7]. Tiotropium bromide is a new type of long-acting anticholinergic drug which produces effects such as dilation of the airway, inhibition of tension of cholinergic nerve, inhibition of airway mucosal secretion, and antiinflammation.…”

Section: Introductionmentioning

confidence: 99%

Effect of non-invasive ventilator in combination with tiotropium bromide on pulmonary function and sleep quality of patients with chronic obstructive pulmonary disease complicated with obstructive sleep apnea-hypopnea syndrome

Liu¹,

He²,

Gao³

et al. 2022

Trop. J. Pharm Res

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Purpose: To study the influence of non-invasive ventilator and tiotropium bromide on pulmonary function and sleep quality of patients with chronic obstructive pulmonary disease (COPD) combined with obstructive sleep apnea-hypopnea syndrome (OSAHS).Methods: One hundred and twenty patients with COPD-OSAHS were selected and randomly assigned to control group (CG) and treatment group (TG), with 60 subjects in each group. Non-invasive ventilator therapy was used in both groups, based on conventional therapy, while tiotropium bromide was added in TG. Treatment effectiveness in the two groups was evaluated and compared.Results: Total effectiveness was significantly higher in TG than in CG. Post-therapy arterial oxygen saturation (SaO2) and oxygen partial pressure (PaO2) were increased, while partial pressure of carbon dioxide (PaCO2) and lactic acid (Lac) were decreased in both groups (p < 0.05). Post-treatment values of indices of lung function, viz, forced expiratory volume (FEV1), forced vital capacity (FVC) and FEV1/FVC ratio were higher than the corresponding pre-treatment levels, and also values were significantly higher in TG than in CG (p < 0.05). Average sleep time, apnea and hypopnea index (AHI) and mechanical ventilation time of TG were less than those of CG. There were lower levels of Creactive protein (CRP), procalcitonin (PCT) and interleukin-17 (IL-17) in TG than in CG. During the treatment, no obvious adverse reaction was seen in both groups.Conclusion: Non-invasive ventilator, in combination with tiotropium bromide, is more effective in the treatment of COPD-OSAHS than the use of non-invasive ventilator alone. However, further clinical trials are required before its adoption in clinical practice.

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Section: Introductionmentioning

confidence: 99%