SPIRIVA RESPIMAT deposited approximately 40% of the labelled dose into the lungs*

Image for illustrative purposes only.

  • *
    Remainder deposited in the gastrointestinal tract.
  • Clinical significance unknown.

SPIRIVA RESPIMAT inhaler

The SPIRIVA RESPIMAT inhaler generates a propellant-free mist-like cloud of medicine

SPIRIVA RESPIMAT product open with mist emerging and a circular callout saying that it is the only LAMA with an indication to reduce the risk of COPD exacerbations

 

 

 

‡ Comparative clinical significance unknown.

TUDORZA GENUAIR (aclidinium bromide) is indicated as a long-term maintenance bronchodilator treatment in patients with chronic obstructive pulmonary disease (COPD). including chronic bronchitis and emphysema.

TUDORZA GENUAIR is not indicated for the relief of an acute deterioration of COPD.

SEEBRI® BREEZHALER® (glycopyrronium bromide) is indicated as a long-term once-daily maintenance bronchodilator treatment in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.

SEEBRI BREEZHALER is not indicated for the relief of an acute deterioration of COPD. 

SPIRIVA RESPIMAT (tiotropium bromide monohydrate) is 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, and for the reduction of exacerbations.

SPIRIVA RESPIMAT is indicated as add-on maintenance bronchodilator treatment in adult patients with asthma who remain symptomatic on a combination of inhaled corticosteroid (equivalent to, but not limited to ≥500 mcg fluticasone/day or ≥800 mcg budesonide/day) and a long acting β2-agonist and who experienced one or more severe exacerbations in the previous year.

SPIRIVA RESPIMAT is not indicated as rescue medication for the relief of acute bronchospasm in COPD or asthma.


 

COPD efficacy

In pooled Phase III, 48-week studies (coprimary endpoint), SPIRIVA RESPIMAT demonstrated significant improvement in lung function (trough FEV1) vs. placebo§

Graph of  Trough FEV1 change from baseline over 48 weeks in pooled studies


Adapted from SPIRIVA RESPIMAT Product Monograph.

Trough FEV1 change full text

127 mL difference in mean trough FEV1 vs. placebo was seen on day 337 (p<0.0001)

In pooled Phase III, 48-week studies (secondary endpoints), SPIRIVA RESPIMAT treatment resulted in:§
  • 29% reduced risk of COPD exacerbations
  • Patients with ≥1 exacerbation: SPIRIVA RESPIMAT (n=249/670) vs. placebo (n=288/653)
  • For maintenance treatment + reduction of exacerbations

Patients with ≥1 hospitalization: (n=39/670) with SPIRIVA RESPIMAT and (n=44/653) with placebo

  • §
    Two randomized, double-blind, placebo-controlled, 48-week trials of once-daily SPIRIVA RESPIMAT (n=650) and control group (n=603). All respiratory medications, except anticholinergics and long-acting beta-agonists, were permitted during the trial.

Asthma

Use SPIRIVA RESPIMAT as add-on maintenance bronchodilator treatment in adult patients with asthma who remain symptomatic on a combination of inhaled corticosteroid (equivalent to, but not limited to ≥500 mcg fluticasone/day or ≥800 mcg budesonide/day) and a long acting β2 agonist and who experienced one or more severe exacerbations in the previous year.

The need for continued therapy should be periodically reassessed based upon the patient’s disease severity and level of asthma control.

Recommended dose of SPIRIVA RESPIMAT

The RESPIMAT inhaler generates a propellant-free mist-like cloud of medicine.

2 inhalations of 2.5 mcg
Once daily from the RESPIMAT inhaler at the same time of day
Every day
Spacer device not required

SPIRIVA RESPIMAT must be taken with an inhaled corticosteroid and a LABA for patients with asthma.

For complete dose instructions, refer to the Product Monograph.
 

Member of Innovative Medicines Canada, Reviewed by PAAB