open to reduce COPD exacerbations

Uplift Trial Study Description

From a 4-year, multicenter, randomized, double-blind, placebo-controlled, parallel-group trial comparison of Spiriva 18 µg once daily (n=2,986) and placebo (n=3,006) 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. Common baseline mean FEV1 was 1.10 L. Spiriva did not slow the yearly rate of lung function decline vs control.17

*COPD exacerbations were defined as an increase or new onset of more than one of the following respiratory symptoms (cough, sputum, sputum purulence, wheezing, dyspnea) with a duration of 3 or more days requiring treatment with antibiotics and/or systemic (oral, intramuscular, or intravenous) steroids.

  • In the 4-year Uplift trial, Spiriva did not slow the yearly rate of decline in pre- and post-bronchodilator FEV1 vs control, which were the co-primary endpoints of the study (p=NS)17
  • Exacerbations were evaluated as a secondary endpoint in the Uplift study17
  • In a separate 6-month study, in a Veterans Affairs (VA) setting, Spiriva reduced the proportion of COPD patients who experienced exacerbations compared with placebo (27.9% vs 32.3%, respectively; p=0.037)16
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Important Safety Information (please scroll)

Spiriva® HandiHaler® (tiotropium bromide inhalation powder) is contraindicated in patients with a history of hypersensitivity to tiotropium, ipratropium (atropine derivatives), or any components of Spiriva capsules.

Spiriva HandiHaler is not indicated for the initial treatment of acute episodes of bronchospasm, i.e., rescue therapy.

Immediate hypersensitivity reactions, including urticaria, angioedema (swelling of lips, tongue or throat), rash, bronchospasm, anaphylaxis, or itching may occur after administration of Spiriva. Additionally, inhaled medicines, including Spiriva, may cause paradoxical bronchospasm. If any of these occurs, treatment with Spiriva should be stopped and other treatments considered.

Patients with a history of hypersensitivity reactions to atropine should be closely monitored for similar hypersensitivity reactions to Spiriva.

Use with caution in patients with severe hypersensitivity to milk proteins.

Spiriva HandiHaler should be used with caution in patients with narrow-angle glaucoma or urinary retention. Prescribers should instruct patients to consult a physician immediately should any signs or symptoms of narrow-angle glaucoma, or prostatic hyperplasia or bladder-neck obstruction occur.

Since dizziness and blurred vision may occur with the use of Spiriva HandiHaler, caution patients about engaging in activities such as driving a vehicle or operating appliances or machinery.

As Spiriva is a predominantly renally excreted drug, Spiriva use should be monitored closely in patients with moderate to severe renal impairment (creatinine clearance of ≤ 50 mL/min).

Spiriva HandiHaler has been used concomitantly with short-acting and long-acting sympathomimetic (beta-agonists) bronchodilators, methylxanthines, and oral and inhaled steroids without increases in adverse drug reactions.

Spiriva may interact additively with concomitantly used anticholinergic medications. Avoid coadministration with other anticholinergic-containing drugs.

The most common adverse reactions in the 1-year placebo-controlled trials were dry mouth, upper respiratory tract infection, sinusitis, pharyngitis, non-specific chest pain, and urinary tract infection. In addition, the most commonly reported adverse reactions from the 4-year trial not included above were headache, constipation, depression, insomnia, and arthralgia.

Spiriva capsules should not be swallowed and should only be inhaled through the mouth (oral inhalation) using the HandiHaler device. The HandiHaler device should not be used for administering other medications.

Spiriva capsules should always be stored in the sealed blisters, and only removed immediately before use, or else its effectiveness may be reduced.

Please refer to the Instructions for Use for additional information on the use of Spiriva HandiHaler.

Indication

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, and for reducing COPD exacerbations.

Click here for full Prescribing Information and Instructions for Use

Important Safety Information (please scroll)

Spiriva® HandiHaler® (tiotropium bromide inhalation powder) is contraindicated in patients with a history of hypersensitivity to tiotropium, ipratropium (atropine derivatives), or any components of Spiriva capsules.

Spiriva HandiHaler is not indicated for the initial treatment of acute episodes of bronchospasm, i.e., rescue therapy.

Immediate hypersensitivity reactions, including urticaria, angioedema (swelling of lips, tongue or throat), rash, bronchospasm, anaphylaxis, or itching may occur after administration of Spiriva. Additionally, inhaled medicines, including Spiriva, may cause paradoxical bronchospasm. If any of these occurs, treatment with Spiriva should be stopped and other treatments considered.

Patients with a history of hypersensitivity reactions to atropine should be closely monitored for similar hypersensitivity reactions to Spiriva.

Use with caution in patients with severe hypersensitivity to milk proteins.

Spiriva HandiHaler should be used with caution in patients with narrow-angle glaucoma or urinary retention. Prescribers should instruct patients to consult a physician immediately should any signs or symptoms of narrow-angle glaucoma, or prostatic hyperplasia or bladder-neck obstruction occur.

Since dizziness and blurred vision may occur with the use of Spiriva HandiHaler, caution patients about engaging in activities such as driving a vehicle or operating appliances or machinery.

As Spiriva is a predominantly renally excreted drug, Spiriva use should be monitored closely in patients with moderate to severe renal impairment (creatinine clearance of ≤ 50 mL/min).

Spiriva HandiHaler has been used concomitantly with short-acting and long-acting sympathomimetic (beta-agonists) bronchodilators, methylxanthines, and oral and inhaled steroids without increases in adverse drug reactions.

Spiriva may interact additively with concomitantly used anticholinergic medications. Avoid coadministration with other anticholinergic-containing drugs.

The most common adverse reactions in the 1-year placebo-controlled trials were dry mouth, upper respiratory tract infection, sinusitis, pharyngitis, non-specific chest pain, and urinary tract infection. In addition, the most commonly reported adverse reactions from the 4-year trial not included above were headache, constipation, depression, insomnia, and arthralgia.

Spiriva capsules should not be swallowed and should only be inhaled through the mouth (oral inhalation) using the HandiHaler device. The HandiHaler device should not be used for administering other medications.

Spiriva capsules should always be stored in the sealed blisters, and only removed immediately before use, or else its effectiveness may be reduced.

Please refer to the Instructions for Use for additional information on the use of Spiriva HandiHaler.

Indication

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, and for reducing COPD exacerbations.

Click here for full Prescribing Information and Instructions for Use

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