SPIRIVA SUMMARY
Spiriva®
HandiHaler®
(tiotropium bromide inhalation powder)
Tiotropium is a long-acting, antimuscarinic agent, which is often referred to as an anticholinergic. It has similar affinity to the subtypes of muscarinic receptors, M1 to M5.
SPIRIVA® HandiHaler® (tiotropium bromide inhalation powder) consists of a capsule dosage form containing a dry powder formulation of SPIRIVA (tiotropium bromide) intended for oral inhalation only with the HandiHaler inhalation device.
SPIRIVA HandiHaler is indicated for the long-term, once-daily, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.
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NEWS HIGHLIGHTSMedia Articles Related to Spiriva (Tiotropium Inhalation)
FDA Advisory Committee Finds Data Support The Claim That SPIRIVA(R) HandiHaler(R) Reduces COPD Exacerbations
Source: Respiratory / Asthma News From Medical News Today [2009.11.20]
The U.S. Food and Drug Administration (FDA) Pulmonary-Allergy Drugs Advisory Committee voted 11 to 1 that clinical data included in a supplemental new drug application (sNDA) provide substantial and convincing evidence to support the claim that SPIRIVA® HandiHaler® (tiotropium bromide inhalation powder) reduces exacerbations (worsening of symptoms) in patients with chronic obstructive pulmonary disease (COPD).
FDA Panel Finds Tiotropium Safe for COPD Patients
Source: MedPageToday.com - medical news plus CME for physicians [2009.11.20]
An FDA committee said new data allay concerns about the risk of stroke and cardiovascular events previously associated with tiotropium (Spiriva), drugmaker Boehringer Ingelheim said.
Published Studies Related to Spiriva (Tiotropium Inhalation)
Effect of tiotropium on outcomes in patients with moderate chronic obstructive pulmonary disease (UPLIFT): a prespecified subgroup analysis of a randomised controlled trial. [2009.10.03]
BACKGROUND: The beneficial effects of pharmacotherapy for chronic obstructive pulmonary disease (COPD) are well established. However, there are few data for treatment in the early stages of the disease. We examined the effect of tiotropium on outcomes in a large subgroup of patients with moderate COPD... INTERPRETATION: Tiotropium seemed to reduce the rate of decline of postbronchodilator FEV(1) in patients with GOLD stage II COPD. This finding and the other improvements in outcomes suggest that treatment of COPD should begin at an early stage of the disease. FUNDING: Boehringer Ingelheim and Pfizer Pharmaceuticals.
Tiotropium and risk for fatal and nonfatal cardiovascular events in patients with chronic obstructive pulmonary disease: systematic review with meta-analysis. [2009.10]
BACKGROUND: There are safety concerns regarding the use of anticholinergics in the COPD patient population. The purpose of this review was to evaluate the cardiovascular risk of regular use of inhaled tiotropium bromide in patients with COPD of any severity... CONCLUSIONS: Compared with control (placebo or salmeterol), tiotropium did not significantly increase the risk of adverse major cardiovascular events among COPD patients. Subgroup analysis suggested that smoking history can modify the risk of cardiovascular adverse events.
Cardiovascular Safety of Tiotropium in Patients With COPD. [2009.07.10]
BACKGROUND: The clinical trial safety database for tiotropium has been augmented with a 4-year trial in COPD patients, which provides an opportunity to better evaluate the cardiovascular(CV) profile of tiotropium... CONCLUSION: Tiotropium was associated with a reduction in the risk of all-cause mortality, cardiovascular mortality and cardiovascular events.
Anti-inflammatory effects of salmeterol/fluticasone, tiotropium/fluticasone or tiotropium in COPD. [2009.04]
The anti-inflammatory effects of salmeterol/fluticasone (SFP), tiotropium/fluticasone (Tio+FP) and tiotropium (Tio) alone were investigated on the inflammatory cells and mediators in sputum induced from chronic obstructive pulmonary disease patients...
UPLIFT Study: the effects of long-term therapy with inhaled tiotropium in chronic obstructive pulmonary disease. Evaluation of: Tashkin DP, Celli B, Senn S et al.: a 4-year trial of tiotropium in chronic obstructive pulmonary disease. N Engl J Med (2008) 359(15):1543-1554. [2009.03]
CONCLUSIONS: Tiotropium bromide, alone or in combination with other inhaled therapies, can maintain an adequate control of COPD on a long-term basis.
Clinical Trials Related to Spiriva (Tiotropium Inhalation)
Efficacy and Safety Comparison of Tiotropium Inhalation Solution (Respimat Inhaler) and Spiriva HandiHaler in COPD [Completed]
Efficacy and Safety Comparison of Tiotropium Inhalation Solution (Respimat Inhaler) and Spiriva HandiHaler in COPD [Completed]
Acute Bronchodilator Response of a Single Dose of Atrovent or Berotec on Top of Pharmacodynamic Steady State of Spiriva [Completed]
To evalute acute effect of single dose of ipratropium (Atrovent) or fenoterol (Berotec) in
comparison to placebo when given to COPD patients on pharmacodynamic steady state of
tiotropium (Spiriva)
Tiotropium Induced Bronchodilation in Lung CT Scored Emphysema [Completed]
To evaluate if tiotropium (Spiriva)induced bronchodilation of inspiratory capacity in
patients with moderate to severe copd subjected to metronome paced hyperventilation induced
dynamic hyperinflation is dependent upon the extent of underlying emphysema as determined by
high resolution-thin section CT lung.
Spiriva® Assessment of FEV1 (SAFE). [Completed]
The objective of this trial was to evaluate whether the effect of one year (48 weeks)
treatment with inhaled tiotropium bromide (Spiriva®)(18 µg once daily) on the change in
trough FEV1, compared to placebo in patients with COPD, was affected by smoking status.
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 1 ratings/reviews, Spiriva has an overall score of 9. The effectiveness score is 10 and the side effect score is 10. The scores are on ten point scale: 10 - best, 1 - worst.
| | Spiriva review by 57 year old female patient | | | Rating |
| Overall rating: | |   |
| Effectiveness: | | Highly Effective |
| Side effects: | | No Side Effects | | |
Treatment Info |
| Condition / reason: | | Asthma |
| Dosage & duration: | | 1 puff (dosage frequency: bid) for the period of current |
| Other conditions: | | Bronchitis |
| Other drugs taken: | | Symbicort | | |
Reported Results |
| Benefits: | | I used to live on my MDI(combivent). I started maintenance drugs Spiriva and Symbicort and it has changed my world. I, on adverage, dont have to take my MDI at all anymore. I have my days that I have to, living in Texas can be a nightmare of allergies. I can do more activities without feeling so short of breath. I have not had any major side effects yet...Overall after starting Spiriva I'm doing much better. For anyone with Asthma I would suggest they try this drug. |
| Side effects: | | I have really had no major side effects yet. Maybe, if any, a headache and I'm not sure that is one? |
| Comments: | | Well, theres not a whole lot to say about the treatment details. I take one dose per day in the morning. Its a dry disk powder that you inhale. Its very easy, quick, and seems to work very fast. |
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Page last updated: 2009-11-20
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