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Spiriva (Tiotropium Bromide Monohydrate Inhalation) - Summary



SPIRIVA HandiHaler consists of a capsule dosage form containing a dry powder formulation of tiotropium intended for oral inhalation only with the HandiHaler device. Each light green, hard gelatin SPIRIVA capsule contains 18 mcg tiotropium (equivalent to 22.5 mcg tiotropium bromide monohydrate) blended with lactose monohydrate (which may contain milk proteins) as the carrier. The dry powder formulation within the SPIRIVA capsule is intended for oral inhalation only. The active component of SPIRIVA HandiHaler is tiotropium. The drug substance, tiotropium bromide monohydrate, is an anticholinergic with specificity for muscarinic receptors.

SPIRIVA HandiHaler (tiotropium bromide inhalation powder) is indicated for the long-term, once-daily, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. SPIRIVA HandiHaler is indicated to reduce exacerbations in COPD patients.

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Published Studies Related to Spiriva (Tiotropium Inhalation)

Predictors of response to tiotropium versus salmeterol in asthmatic adults. [2013]
corticosteroid, as well as predictors of a positive clinical response... CONCLUSION: Although these results require confirmation, predictors of a positive

Combined therapy with tiotropium and formoterol in chronic obstructive pulmonary disease: effect on the 6-minute walk test. [2013]
Combined therapy with tiotropium and long-acting beta 2 agonists confers additional improvement in symptoms, lung function and aspects of health-related quality of life (QOL) compared with each drug alone in patients with COPD. However, the efficacy of combined therapy on walking distance, a surrogate measure of daily functional activity and morbidity remains unclear.

Acute effects of indacaterol on lung hyperinflation in moderate COPD: A comparison with tiotropium. [2012.01]
BACKGROUND: Evidence has been provided that high-dose indacaterol (300 mug) can reduce lung hyperinflation in moderate-to-severe chronic obstructive pulmonary disease (COPD). AIM: To study whether low-dose indacaterol (150 mug) also reduces lung hyperinflation in comparison with the recommended dose of tiotropium (18 mug) in moderate COPD... CONCLUSIONS: Low-dose indacaterol has a bronchodilator effect that is similar to the recommended dose of tiotropium, but it is slightly superior in reducing lung hyperinflation. TRIAL REGISTRATION: ClinicalTrials.gov number: NCT00999908. Copyright (c) 2011 Elsevier Ltd. All rights reserved.

Tiotropium is noninferior to salmeterol in maintaining improved lung function in B16-Arg/Arg patients with asthma. [2011.08]
BACKGROUND: The efficacy and safety of inhaled long-acting beta(2)-adrenergic agonists in asthmatic patients with the B16-Arg/Arg genotype has been questioned, and the use of antimuscarinics has been proposed as an alternative in patients whose symptoms are not controlled by inhaled corticosteroids (ICSs). OBJECTIVE: We compared the efficacy and safety of the long-acting anticholinergic tiotropium with salmeterol and placebo added to an ICS in B16-Arg/Arg patients with asthma that was not controlled by ICSs alone... CONCLUSION: Tiotropium was more effective than placebo and as effective as salmeterol in maintaining improved lung function in B16-Arg/Arg patients with moderate persistent asthma. Safety profiles were comparable. Copyright (c) 2011 American Academy of Allergy, Asthma & Immunology. Published by Mosby, Inc. All rights reserved.

Tiotropium improves lung function in patients with severe uncontrolled asthma: a randomized controlled trial. [2011.08]
BACKGROUND: Some patients with severe asthma remain symptomatic and obstructed despite maximal recommended treatment. Tiotropium, a long-acting inhaled anticholinergic agent, might be an effective bronchodilator in such patients. OBJECTIVE: We sought to compare the efficacy and safety of 2 doses of tiotropium (5 and 10 mug daily) administered through the Respimat inhaler with placebo as add-on therapy in patients with uncontrolled severe asthma (Asthma Control Questionnaire score, >/= 1.5; postbronchodilator FEV, </= 80% of predicted value) despite maintenance treatment with at least a high-dose inhaled corticosteroid plus a long-acting beta-agonist... CONCLUSION: The addition of once-daily tiotropium to asthma treatment, including a high-dose inhaled corticosteroid plus a long-acting beta-agonist, significantly improves lung function over 24 hours in patients with inadequately controlled, severe, persistent asthma. Copyright (c) 2011 American Academy of Allergy, Asthma & Immunology. Published by Mosby, Inc. All rights reserved.

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Clinical Trials Related to Spiriva (Tiotropium Inhalation)

Dynamic Hyperinflation and Tiotropium [Completed]
We will detect dynamic hyperinflation (DH) in 40 COPD (chronic obstructive pulmonary disease) patients with moderately severe disease using metronome paced hyperventilation (MPH) with inspiratory capacity as the primary end point. Hypothesis: Is tiotropium capable of lung volume protecting inspiratory capacity from MPH induced DH vs placebo in a randomized crossover double blinded study.

A Study of Arformoterol Tartrate Inhalation Solution and Tiotropium Bromide on Re-hospitalization in Chronic Obstructive Pulmonary Disease (COPD) Subjects [Recruiting]
This is a randomized, open-label, parallel group, multicenter, outpatient study in COPD subjects who are discharged from the hospital due to a COPD exacerbation. Subjects who meet the eligibility criteria will be randomized to 1 of 2 treatments: arformoterol tartrate inhalation solution (BROVANA) 15 mcg twice daily (BID) or tiotropium bromide (SPIRIVA) 18 mcg once daily (QD), each given for 90 days.

Blacks and Exacerbations on Long Acting Beta Agonists (LABA) vs. Tiotropium (BELT) [Completed]
We are doing this study to learn how genes affect the way that people, specifically Black people, respond to treatment for asthma. Recent studies suggest that people respond differently to some asthma medications (eg Serevent, Foradil). Some people feel better when they use these inhalers, but others may not, and some people get worse. It seems that this difference shows up more often in Blacks than in Whites, which is why we are looking for Black subjects for this study. In all people, this difference seems to depend on their genes or DNA. This study is comparing the use of long acting asthma medications (Serevent, Foradil) to Tiotropium (Spiriva) for the treatment of asthma. Spiriva is used to treat chronic obstructive pulmonary disease (COPD). This study will help to see if this medication is also useful for treating asthma and whether it works better for some people than the current asthma medications.

Study to Evaluate the Effects of Tiotropium Bromide on Chronic Obstructive Pulmonary Disease (COPD) During Exercise [Completed]
The purpose of this study is to determine the effect of treatment with tiotropium bromide on efficiency of gas exchange and exercise performance in COPD subjects during exercise.

A Study of 3 Doses of Tiotropium Hydrofluoralkane (HFA) Breath Actuated Inhaler (BAI), in Patients With Chronic Obstructive Pulmonary Disease [Withdrawn]
The primary objective of this study is to demonstrate the superiority of tiotropium hydrofluoroalkane (HFA) breath actuated inhaler (BAI) to placebo HFA BAI following repeated, once-daily dosing.

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Reports of Suspected Spiriva (Tiotropium Inhalation) Side Effects

Incorrect Route of Drug Administration (1887)Dyspnoea (640)Drug Ineffective (271)DRY Mouth (140)Pneumonia (131)Cough (119)Chronic Obstructive Pulmonary Disease (111)Bronchitis (79)Death (70)Chest Discomfort (68)more >>


Based 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

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: 2014-11-30

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