Drug updated on 9/5/2024
| Dosage Form | Inhalation spray (oral; 1.25 mcg or 2.5 mcg [2.5 mcg or 5 mcg]) |
| Drug Class | Anticholinergics |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the long-term, once-daily, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), and for reducing COPD exacerbations.
- Indicated for the long-term, once-daily, maintenance treatment of asthma in patients 6 years of age and older.
Latest News
Summary
- Spiriva Respimat (tiotropium bromide) is indicated for the long-term, once-daily, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), for reducing COPD exacerbations, and for the long-term, once-daily, maintenance treatment of asthma in patients 6 years of age and older.
- This summary is based on the review of three systematic review(s)/meta-analysis(es). [1-3]
- In COPD patients, umeclidinium/vilanterol (UMEC/VI) demonstrated statistically significant greater improvements in forced expiratory volume in 1 second (FEV1) at 24 weeks and in the St. George's Respiratory Questionnaire (SGRQ) total score compared to tiotropium 18 µg.
- In asthma patients, 2.5 µg tiotropium Respimat® as an add-on to inhaled corticosteroids consistently improved lung function parameters, including peak and trough FEV1 and forced vital capacity (FVC), across children, adolescents, and adults, versus placebo.
- In COPD patients, a meta-analysis of 20 RCTs (27,699 subjects) found no increased risk of cardiovascular events (Peto OR, 0.97; 95% CI, 0.84-1.12), overall mortality (RD, 0.00; 95% CI, -0.00-0.01), or cardiovascular mortality (Peto OR, 1.58; 95% CI, 0.92-2.74) associated with tiotropium use.
- In asthma patients, RCTs assessing 2.5 µg tiotropium Respimat® reported a safety profile comparable to placebo, with commonly observed adverse events including asthma worsening, reduction in peak expiratory rate, nasopharyngitis, and respiratory tract infections.
- There is no population type or subgroup information available in the reviewed studies.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Spiriva Respimat (tiotropium bromide) Prescribing Information. | 2021 | Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| Comparative efficacy of umeclidinium/vilanterol versus other bronchodilators for the treatment of chronic obstructive pulmonary disease: a network meta-analysis. | 2022 | Advances in Therapy |
| Association of tiotropium use and the risk of adverse cardiovascular events in patients with chronic obstructive pulmonary disease: a meta-analysis of randomized controlled trials. | 2020 | European Journal of Clinical Pharmacology |
| Burden of asthma and role of 2.5 µg tiotropium respimat® as an add-on therapy: a systematic review of phase 2/3 trials. | 2019 | Advances in Therapy |
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| Asthma guideline updates. | 2022 | ACSAP: Pulmonary Care |