SPIRIVA® HANDIHALER® (tiotropium bromide inhalation powder) Is Proven to Improve Clinical Outcomes
SPIRIVA HANDIHALER (tiotropium bromide inhalation powder) did not slow the yearly rate of decline in pre- or post-bronchodilator FEV1 vs placebo, the co-primary endpoints of the study (p=0.95, p=0.21, respectively).
- Study Design
A 4-year, multicenter, randomized, double-blind, placebo-controlled, parallel-group trial comparison of SPIRIVA HANDIHALER 18 µg once daily and control in patients with COPD. The 2 co-primary endpoints were the yearly rate of decline in mean FEV1 before and after use of a study drug and short-acting bronchodilators from Day 30 until completion of double-blind treatment. Exacerbations were evaluated as a secondary outcome. Exacerbations were defined as an increase in or the new onset of more than one respiratory symptom (cough, sputum, sputum purulence, wheezing, or dyspnea) lasting 3 days or more and requiring treatment with an antibiotic or a systematic corticosteroid. Baseline mean pre-bronchodilator FEV1 was 1.10 L, 39% of predicted value. SPIRIVA HANDIHALER did not slow the yearly rate of lung function decline vs control. Major inclusion criteria included patients with a diagnosis of COPD, 40 years of age or older, a smoking history of 10 pack-years or more, a post-bronchodilator FEV1 of 70% or less of the predicted value, and an FEV1 of 70% or less of the FVC. Patients were permitted to use all respiratory medications (including short-acting and long-acting beta-agonists, inhaled and systemic steroids, and theophyllines) other than inhaled anticholinergics.
FEV1=forced expiratory volume in 1 second; FVC=forced vital capacity.
SPIRIVA RESPIMAT delivers a slow‑moving mist that helps patients inhale the medication.3,4Learn more about SPIRIVA RESPIMAT
Established Safety Profile
Adverse reactions (% patients) in 1‑year COPD clinical trials1
This table shows all adverse reactions that occurred with a frequency of ≥3% in the SPIRIVA HANDIHALER group in the 1-year placebo-controlled trials where the rates in the SPIRIVA HANDIHALER group exceeded placebo by ≥1%. The frequency of corresponding reactions in the ipratropium-controlled trials is included for comparison.
4‑year UPLIFT trial
In addition, the most common reported adverse reaction ≥3% incidence and higher than placebo from the 4‑year trial with SPIRIVA HANDIHALER (placebo) not included above were headache 5.7% (4.5%), depression 4.4% (3.3%), insomnia 4.4% (3.0%), and arthralgia 4.2% (3.1%).
- Once daily, 2 inhalations (18 µg)
- 1 capsule daily
- Dry-powder capsule