General Information

Striverdi Respimat (olodaterol) inhalation spray is a long-acting beta2-adrenergic agonist.

Striverdi Respimat is specifically indicated as a long-term, once-daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

Striverdi Respimat is supplied as spray for oral inhalation. The recommended dose is two inhalations once-daily at the same time of day. Do not use more than two inhalations every 24 hours.

Clinical Results

The FDA approval of Striverdi Respimat for COPD was based on three dose-ranging trials and eight confirmatory trials.

Dose-ranging trials:

The first COPD dose-ranging trial was a randomized, double-blind, placebo-controlled, single-dose, 5-way cross-over trial in 36 patients. Results demonstrated dose-related improvements in forced expiratory volume in one second (FEV1) compared to placebo. The difference in trough FEV1 from placebo for the 2, 5, 10, and 20 mcg doses were 0.07L, 0.10L, 0.11L and 0.12L, respectively. The second COPD dose-ranging trial was a 4-week, randomized, double-blind, placebo-controlled, parallel group trial in 405 patients. Dose-related improvements in lung function were also seen, with no added benefit of the 20 mcg dose over the 10 mcg dose. The third trial was a randomized, double blind, 4-way crossover dose-regimen trial in 47 patients. Treatment arms included 2 mcg twice-daily, 5 mcg once-daily, 5 mcg twice-daily, and 10 mcg once-daily. There was no clear difference between twice-daily and once-daily dosing.

Confirmatory trials:

The eight confirmatory trials were four pairs of replicate, randomized, double-blind, placebo-controlled trials in 3533 COPD patients (1281 received the 5 mcg dose, 1284 received the 10 mcg dose).These included four 48-week trials and four 6-week crossover trials. In all four 48-week trials, Striverdi Respimat 5 mcg demonstrated significant improvements in FEV1 AUC 0-3hr compared to placebo at week 12 and at week 24. In the four 48-week trials, Striverdi Respimat 5 mcg demonstrated significant improvements in trough FEV1 compared to placebo at week 12 and at week 24. Striverdi Respimat 5 mcg demonstrated a bronchodilatory treatment effect at 5 minutes after the first dose with a mean increase in FEV1 compared to placebo of 0.11L (range: 0.10L to 0.12L). The 10 mcg dose demonstrated no additional benefit over the 5 mcg dose. Patients treated with Striverdi Respimat 5 mcg used less rescue albuterol compared to patients treated with placebo.

Mechanism of Action

Striverdi Respimat (olodaterol) inhalation spray is a long-acting beta2-adrenergic agonist. The compound exerts its pharmacological effects by binding and activation of beta2-adrenoceptors after topical administration by inhalation. Activation of these receptors in the airways results in a stimulation of intracellular adenyl cyclase, an enzyme that mediates the synthesis of cyclic-3’, 5’ adenosine monophosphate (cAMP). Elevated levels of cAMP induce bronchodilation by relaxation of airway smooth muscle cells.