Comparative study of the pharmacokinetics and pharmacodynamics of tiotropium bromide in the form of aerosol for inhalation and a powder inhaler in patients with chronic obstructive pulmonary disease: results of a clinical study

Tiotropium bromide is a long-acting antimuscarinic drug that is often referred to as an anticholinergic in clinical practice. Its high affinity for muscarinic receptors and slow dissociation provide a pronounced and prolonged bronchodilatory effect in patients with chronic obstructive pulmonary disease (COPD). Medications containing tiotropium bromide (international nonproprietary name) as the active ingredient have been successfully used in clinical practice for approximately 20 years, with their clinical efficacy and safety confirmed. A novel inhalation delivery of tiotropium bromide via metered-dose inhaler (MDI) has been developed.

Aim. This paper presents the results of an open-label, randomized, crossover comparative study of the pharmacokinetics, pharmacodynamics and safety of tiotropium bromide 9 μg/dose MDI (Bronpriva solopharm, Grotex LLC, Russia) and tiotropium bromide 18 μg dry-powder inhaler (Spiriva®, Boehringer Ingelheim International GmbH, Germany).

Methods. The study enrolled 70 eligible patients with a diagnosis of COPD with moderate bronchial obstruction (forced expiratory volume in 1 second (FEV₁) in the post-bronchodilator test: 50% ≲ FEV₁ < 80%; FEV₁ / forced vital capacity (FVC) < 70%). Patients were randomized into 2 equal groups and received therapy with the tiotropium bromide 9 μg/dose and the tiotropium bromide 18 μg dry-powder inhaler. Pharmacodynamic equivalence was measured based on statistical analysis (ANOVA) of pulmonary distribution parameters (FEV₁, peak expiratory flow) of tiotropium bromide.

Conclusion. Tiotropium bromide 9 μg/dose MDI and tiotropium bromide 18 μg dry-powder inhaler were found to be pharmacodynamically equivalent. Tiotropium bromide delivered via MDI has a favorable safety profile.

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