Trial reportJournal of clinical pharmacology2014
Pharmacokinetics and pharmacodynamics of tiotropium solution and tiotropium powder in chronic obstructive pulmonary disease.
Trial report in Journal of clinical pharmacology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 31 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
31 citing papers in PubMed, 1 synthesis or guideline pooled it.
- A systematic review of comparative studies of tiotropium Respimat® and tiotropium HandiHaler® in patients with chronic obstructive pulmonary disease: does inhaler choice matter?BMC pulmonary medicine · 2016Pooled it
- Hair analysis of formoterol as a novel tool to assess long-term inhalation medication adherence: Data from the TRICOLON trial.British journal of clinical pharmacology · 2026Trial
- Dose Determination for a Fixed-Dose Drug Combination: A Phase II Randomized Controlled Trial for Tiotropium/Olodaterol Versus Tiotropium in Patients with COPD.Advances in therapy · 2019Trial
- Particle size and gastrointestinal absorption influence tiotropium pharmacokinetics: a pilot bioequivalence study of PUR0200 and Spiriva HandiHaler.British journal of clinical pharmacology · 2019Trial
- Long-term safety of tiotropium/olodaterol RespimatInternational journal of chronic obstructive pulmonary disease · 2018Trial
- Pharmacokinetic Bioequivalence of Two Inhaled Tiotropium Bromide Formulations in Healthy Volunteers.Clinical drug investigation · 2016Trial
- Tiotropium Respimat(®) Versus HandiHaler(®): Comparison of Bronchodilator Efficacy of Various Doses in Clinical Trials.Advances in therapy · 2016Trial
- Bronchodilator efficacy of 18 μg once-daily tiotropium inhalation via DiscairInternational journal of chronic obstructive pulmonary disease · 2016Trial
- Safety and efficacy of tiotropium in patients switching from HandiHaler to Respimat in the TIOSPIR trial.BMJ open · 2015Trial
- Safety and efficacy of tiotropium Respimat versus HandiHaler in patients naive to treatment with inhaled anticholinergics: a post hoc analysis of the TIOSPIR trial.NPJ primary care respiratory medicine · 2015Trial
- Randomized, Double-Blind, Dose-Finding Study for Tiotropium when Added to Olodaterol, Administered via the Respimat® Inhaler in Patients with Chronic Obstructive Pulmonary Disease.Advances in therapy · 2015Trial
- In Vitro, Pharmacokinetic, Pharmacodynamic, and Safety Comparisons of Single and Combined Administration of Tiotropium and Salmeterol in COPD Patients Using Different Dry Powder Inhalers.The AAPS journal · 2015Trial
- Long-Acting Muscarinic Antagonists for the Treatment of Difficult-to-Treat and Severe Asthma: A Narrative Review Focusing on Inflammation from Bench to Bedside.Journal of inflammation research · 2026Review
- Hair analysis for monitoring adherence to inhaled respiratory medications: possibilities and limitations.European journal of clinical pharmacology · 2025Review
- Proof of lung muscarinic receptor occupancy by tiotropium: Translational Positron Emission Tomography studies in non-human primates and humans.Frontiers in nuclear medicine · 2022Article
- Healthcare Resource Utilization, Exacerbations, and Readmissions Among Medicare Patients with Chronic Obstructive Pulmonary Disease After Long-Acting Muscarinic Antagonist Therapy Initiation with Soft Mist versus Dry Powder Inhalers.International journal of chronic obstructive pulmonary disease · 2020Article
- Predictors of short-term LAMA ineffectiveness in treatment naïve patients with moderate to severe COPD.Wiener klinische Wochenschrift · 2018Article
- Response to Sharma et al.: Long Pulmonary Residence Time and Plasma Half-Life of Tiotropium: Implications for Pharmacokinetic Bioequivalence Studies.Clinical drug investigation · 2017Article
- Tiotropium formulations and safety: a network meta-analysis.Therapeutic advances in drug safety · 2017Article
- Inhaled treatment for chronic obstructive pulmonary disease: what's new and how does it fit?QJM : monthly journal of the Association of Physicians · 2016Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The aim of the study was to characterize pharmacokinetics of tiotropium solution 5 µg compared to powder 18 µg and assess dose-dependency of tiotropium solution pharmacodynamics in comparison to placebo. In total 154 patients with chronic obstructive pulmonary disease (COPD) were included in this multicenter, randomized, double-blind within-solution (1.25, 2.5, 5 µg, and placebo), and open-label powder 18 µg, crossover study, including 4-week treatment periods. Primary end points were peak plasma concentration (Cmax,ss ), and area under the plasma concentration-time profile (AUC0-6h,ss ), both at steady state. The pharmacodynamic response was assessed by serial spirometry (forced expiratory volume in 1 second/forced vital capacity). Safety was evaluated as adverse events and by electrocardiogram/Holter. Tiotropium was rapidly absorbed with a median tmax,ss of 5-7 minutes postdosing for both devices. The gMean ratio of solution 5 µg over powder 18 µg was 81% (90% confidence interval, 73-89%) for Cmax,ss and 76% (70-82%) for AUC0-6h,ss , indicating that bioequivalence was not established. Dose ordering for bronchodilation was observed. Powder 18 µg and solution 5 µg were most effective, providing comparable bronchodilation. All treatments were well tolerated with no apparent relation to dose or device. Comparable bronchodilator efficacy to powder18 µg at lower systemic exposure supports tiotropium solution 5 µg for maintenance treatment of COPD.
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