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Drug Dosage form Dosage Generic/Price Other Class/Mechanism of Action Indications
(FDA-approved)
Side Effects
P = % of patients on placebo
who experienced side effect
Drug Interactions Precautions/
Contraindications
Aclidinium

(Tudorza Pressair®)
Inhaler - Tudorza Pressair®
  • Delivers 400 mcg of aclidinium inhalation powder per actuation
  • Comes in inhaler with 60 or 30 doses
COPD
  • 1 inhalation twice a day
NO/$$$$
  • Discard inhaler 45 days after opening pouch

  • Anticholinergic - blocks muscarinic receptors on bronchial smooth muscle and reduces intrinsic vagal tone of the airway
  • Chronic Obstructive Pulmonary Disease (COPD)

  • Aclidinium is NOT indicated to treat acute bronchospasm
Anticholinergic side effects
  • Pupil dilation - may cause pupils to dilate. Avoid spraying in eyes.
  • Urinary retention - may cause urinary retention
  • See anticholinergic medications for more

From Tudorza PI®
  • Headache - 6.6%, P - 5%
  • Nasopharyngitis - 5.5%, P - 3.9%
  • Cough - 3%, P - 2.2%
  • Diarrhea - 2.7%, P - 1.4%
  • Sinusitis - 1.7%, P - 0.8%
  • Rhinitis - 1.6%, P - 1.2%
  • Severe allergy to milk proteins - DO NOT USE. Contains lactose.
  • Hypersensitivity reactions - hypersensitivity reactions including anaphylaxis have occurred
  • Glaucoma - aclidinium may cause pupil dilation which can precipitate or worsen narrow-angle glaucoma
  • Paradoxical bronchospasm - paradoxical bronchospasm has occurred in some patients
  • Benign prostatic hypertrophy (BPH) - aclidinium may worsen urinary retention seen in BPH
  • Liver disease - has not been studied extensively
  • Kidney disease - no dose adjustment necessary

Drug Dosage form Dosage Generic/Price Other Class/Mechanism of Action Indications
(FDA-approved)
Side Effects
P = % of patients on placebo
who experienced side effect
Drug Interactions Precautions/
Contraindications
Ipratropium

(Atrovent®)

Ipratropium + albuterol

(Combivent®)
(Duoneb®)
Inhaler - Atrovent HFA®
  • Delivers 17 mcg of ipratropium per actuation (200 actuations per inhaler)

Nebulizer
  • Ipratropium 0.02% (500 mcg/2.5 ml)
COPD
Atrovent HFA®
  • 2 puffs four times a day
  • Max: 12 puffs in 24 hours

Nebulizer
  • One neb every 6 - 8 hours

Acute Asthma Exacerbations
See ipratropium in acute exacerbation below
Atrovent HFA®
NO/$$$$

Ipratropium nebs
YES/$

Atrovent HFA®
  • Does not require shaking
  • Prime before first use by releasing 2 test sprays
  • Re-prime inhaler if not used for more than 3 days
  • Avoid spraying in eyes

Nebulizer
  • May mix with albuterol. Use within one hour after mixing.
  • Protect nebs from sunlight

  • Anticholinergic - blocks muscarinic receptors on bronchial smooth muscle and reduces intrinsic vagal tone of the airway
  • Chronic Obstructive Pulmonary Disease (COPD)

  • NHLBI 2007 asthma guidelines state that anticholinergic agents provide additive benefit to SABA in moderate-to-severe asthma exacerbations, and may be used as an alternative bronchodilator for patients who do not tolerate SABA
Anticholinergic side effects
  • Pupil dilation - may cause pupils to dilate. Avoid spraying in eyes.
  • Urinary retention - may cause urinary retention
  • See anticholinergic medications for more

From Atrovent PI®
  • Bronchitis- 10%, P - 6%
  • Shortness of breath - 8%, P - 4%
  • Dizziness- 3%, P - 2%
  • Dry mouth - 4%, P - 2%
  • Nausea- 4%, P - 2%
  • Glaucoma - ipratropium may cause pupil dilation which can precipitate or worsen narrow-angle glaucoma
  • Paradoxical bronchospasm - paradoxical bronchospasm has occurred in some patients
  • Benign prostatic hypertrophy (BPH) - ipratropium may worsen urinary retention seen in BPH
  • Liver disease - has not been studied extensively
  • Kidney disease - has not been studied extensively

Drug Dosage form Dosage Generic/Price Other Class/Mechanism of Action Indications
(FDA-approved)
Side Effects
P = % of patients on placebo
who experienced side effect
Drug Interactions Precautions/
Contraindications
Tiotropium

(Spiriva® Handihaler)

(Spiriva® Respimat)
Spiriva® Handihaler
  • Delivers 18 mcg of tiotropium inhalation powder per actuation
  • Inhalation powder comes in capsule
  • Capsules come in cartons with 30 or 90 capsules

Spiriva® Respimat
  • Carton contains cartridge and inhaler
  • Cartridge contains 60 metered sprays
  • Comes in two doses:
    • Tiotropium 1.25 mcg/actuation
    • Tiotropium 2.5 mcg/actuation
COPD
    Spiriva® Handihaler
    • One capsule once daily
    • Two inhalations should be taken from device for each capsule

    Spiriva® Respimat
    • Two inhalations (5 mcg) once daily
    • Use 2.5 mcg inhaler in COPD

Asthma (≥ 6 years old)
    Spiriva® Respimat
    • Two inhalations (2.5 mcg) once daily
    • Use 1.25 mcg inhaler in Asthma
    • May take up to 8 weeks before full benefit is seen
NO/$$$$ Spiriva® Handihaler
  • May store at room temperature
  • Use capsule immediately after removing from blister pack

Spiriva® Respimat
  • Inhaler is good for 3 months after first use
  • Inhaler must be primed prior to first use and if not used for more than 3 days. See patient instructions for details.
  • Anticholinergic - blocks muscarinic receptors on bronchial smooth muscle and reduces intrinsic vagal tone of the airway
  • Chronic Obstructive Pulmonary Disease (COPD)
  • Tiotropium is indicated for long-term maintenance and prevention of COPD exacerbations
  • Tiotropium is NOT indicated to treat acute bronchospasm
Anticholinergic side effects
  • Pupil dilation - may cause pupils to dilate. Avoid spraying in eyes.
  • Urinary retention - may cause urinary retention
  • See anticholinergic medications for more

From Spiriva® Handihaler PI
  • Upper Respiratory infection - 41%, P - 37%
  • Dry mouth - 16%, P - 3%
  • Sinusitis- 11%, P - 9%
  • Pharyngitis- 9%, P - 7%
  • Chest pain - 7%, P - 5%
  • Urinary tract infection - 7%, P - 5%
  • Shortness of breath - 6%, P - 5%
  • Abdominal pain - 5%, P - 3%

From Spiriva® Respimat PI
  • Pharyngitis- 11.5%, P - 10.1%
  • Cough- 5.8%, P - 5.5%
  • Dry mouth - 4.1%, P - 1.6%
  • Sinusitis - 3.1%, P - 2.7%
  • Severe allergy to milk proteins (Handihaler® only) - DO NOT USE. Contains lactose.
  • Glaucoma - tiotropium may cause pupil dilation which can precipitate or worsen narrow-angle glaucoma
  • Paradoxical bronchospasm - paradoxical bronchospasm has occurred in some patients
  • Benign prostatic hypertrophy (BPH) - ipratropium may worsen urinary retention seen in BPH
  • Liver disease - has not been studied extensively
  • Kidney disease - CrCl ≤ 60 ml/min - monitor patient closely for anticholinergic side effects

Drug Dosage form Dosage Generic/Price Other Class/Mechanism of Action Indications
(FDA-approved)
Side Effects
P = % of patients on placebo
who experienced side effect
Drug Interactions Precautions/
Contraindications
Umeclidinium

(Incruse Ellipta®)
Inhaler - Incruse Ellipta®
  • Delivers 62.5 mcg of umeclidinium inhalation powder per actuation
  • Comes in package with 30 doses
COPD
  • 1 inhalation once daily
  • Inhale at the same time each day
NO/$$$$
  • Discard inhaler 6 weeks after opening foil pouch

  • Anticholinergic - blocks muscarinic receptors on bronchial smooth muscle and reduces intrinsic vagal tone of the airway
  • Chronic Obstructive Pulmonary Disease (COPD)

  • Umeclidinium is NOT indicated to treat acute bronchospasm
Anticholinergic side effects
  • Pupil dilation - may cause pupils to dilate. Avoid spraying in eyes.
  • Urinary retention - may cause urinary retention
  • See anticholinergic medications for more

From Incruse Ellipta PI®
  • Nasopharyngitis - 8%, P - 7%
  • Upper respiratory infection - 5%, P - 4%
  • Cough - 3%, P - 2%
  • Arthralgia - 2%, P - 1%
  • Severe allergy to milk proteins - DO NOT USE. Contains lactose.
  • Glaucoma - umeclidinium may cause pupil dilation which can precipitate or worsen narrow-angle glaucoma
  • Paradoxical bronchospasm - paradoxical bronchospasm has occurred in some patients
  • Benign prostatic hypertrophy (BPH) - umeclidinium may worsen urinary retention seen in BPH
  • Kidney disease - no dose adjustment necessary
  • Liver disease
    • Mild-to-moderate (Child-Pugh A/B): no dose adjustment necessary
    • Severe (Child-Pugh C): has not been studied




Drug Dosage form Dosage Generic/Price Other Indications
(FDA-approved)
Glycopyrrolate + formoterol

(Bevespi Aerosphere™)
Inhaler
  • Device delivers 4.8 mcg of formoterol and 9 mcg of glycopyrrolate per actuation
  • Each inhaler contains 120 inhalations
COPD
  • 2 inhalations twice a day
NO/$$$$

  • Inhaler must be primed. See package insert for instructions.
  • See Bevespi Aerosphere PI for complete prescribing information
  • Inhaler is good for 3 months after removal from foil pouch
  • Chronic Obstructive Pulmonary Disease (COPD)
  • NOT for relief of acute bronchospasm


Drug Dosage form Dosage Generic Other Indications
(FDA-approved)
Glycopyrrolate + indacaterol

(Utibron® Neohaler)
Utibron® Neohaler
  • Inhaler delivers 27.5 mcg of indacaterol and 15.6 mcg of glycopyrrolate per inhalation capsule
  • Inhaler comes with 60 inhalation capsules
COPD
  • 1 inhalation twice a day
  • Use at the same time every day
NO/$$$$
  • See Utibron® PI for complete prescribing information
  • Use with caution in patients with severe milk allergy. Contains lactose.

  • Maintenance treatment of Chronic Obstructive Pulmonary Disease (COPD)

  • NOT for relief of acute bronchospasm


Drug Dosage form Dosage Generic Other Indications
(FDA-approved)
Ipratropium + albuterol

(Combivent Respimat®)

(Duoneb®)
Inhaler - Combivent Respimat®
  • Device delivers 100 mcg of albuterol and 20 mcg of ipratropium per actuation (120 actuations per device)

Nebulizer solution - Duoneb®
  • Ipratropium 0.017% / Albuterol base 0.083% (0.5 mg/2.5 mg per 3 ml neb)
COPD
Combivent Respimat®
  • One inhalation 4 times a day
  • Max - 6 inhalations in 24 hours

Duoneb®
  • One neb 4 times a day
  • Max - 6 nebs in 24 hours

Acute asthma exacerbation

See asthma exacerbation below

Combivent Respimat®
NO/$$$$

Duoneb®
YES/$
  • Combivent Respimat® is good for 3 months after first use
  • See Combivent Respimat® patient insert for priming instructions

  • Chronic Obstructive Pulmonary Disease (COPD)

  • Relief of bronchospasm


Drug Dosage form Dosage Generic Other Indications
(FDA-approved)
Tiotropium + olodaterol

(Stiolto® Respimat)
Stiolto® Respimat inhaler
  • Inhaler delivers 3.124 mcg tiotropium (equivalent to 2.5 mcg tiotropium) and 2.736 mcg olodaterol (equivalent to 2.5 mcg olodaterol) per spray
  • Inhaler comes with 60 actuations
COPD
  • 2 inhalations once daily
  • Use at the same time every day
NO/$$$$
  • See Stiolto® PI for complete prescribing information
  • Inhaler should be primed. See patient instructions for details

  • Maintenance treatment of Chronic Obstructive Pulmonary Disease (COPD)

  • NOT for relief of acute bronchospasm


Drug Dosage form Dosage Generic Other Indications
(FDA-approved)
Umeclidinium + vilanterol

(Anoro Ellipta®)
Anoro Ellipta® inhaler
  • Inhaler delivers 62.5 mcg of umeclidinium powder and 25 mcg of vilanterol powder per inhalation
  • Inhaler comes with 30 inhalations
COPD
  • One inhalation once daily
NO/$$$$
  • See Anoro Ellipta® PI for complete prescribing information
  • Discard inhaler 6 weeks after opening the foil tray
  • DO NOT USE in patients with severe milk allergy
  • Vilanterol is a CYP3A4 substrate. Use caution with strong CYP3A4 inhibitors.

  • Maintenance treatment of Chronic Obstructive Pulmonary Disease (COPD)

  • NOT for relief of acute bronchospasm





Reference [1]
Acute asthma exacerbation
Child dose
(≤ 12 years old)
Adult dose (≥ 13 years old) Other
Ipratropium nebulizer
(0.5 mg/2.5 ml)
0.25–0.5 mg every 20 minutes for 3 doses, then as needed 0.5 mg every 20 minutes for 3 doses then as needed May mix in same nebulizer with albuterol. Should not be used as first-line therapy; should be added to SABA therapy for severe exacerbations. The addition of ipratropium has not been shown to provide further benefit once the patient is hospitalized.
Atrovent HFA® 4–8 puffs every 20 minutes as needed up to 3 hours 8 puffs every 20 minutes as needed up to 3 hours Should use with VHC and face mask for children < 4 years. Studies have examined ipratropium bromide MDI for up to 3 hours.
Duoneb®
(0.5 mg/2.5 mg per 3 ml neb)
1.5 - 3 mL every 20 minutes for 3 doses, then as needed 3 mL every 20 minutes for 3 doses, then as needed May be used for up to 3 hours in the initial management of severe exacerbations. The addition of ipratropium to albuterol has not been shown to provide further benefit once the patient is hospitalized.
Combivent Respimat® 4 – 8 puffs every 20 minutes as needed up to 3 hours 8 puffs every 20 minutes as needed up to 3 hours Should use with VHC and face mask for children < 4 years




Study Criteria Intervention Primary outcome Results

Tiotropium
vs
LABA
in adult black asthmatics


BELT trial

JAMA 2015

PubMed abstract
Inclusion criteria:
  • Black adults 18 - 75 years old
  • Physician-diagnosed asthma
  • Taking LABA + ICS or taking ICS and having an Asthma Control Questionnaire (ACQ) score higher than 1.25

Exclusion criteria:
  • Current smoker or smoking history > 10 pack-years
  • FEV < 40% predicted
  • ICU admission for asthma in past 5 years
  • Exacerbation requiring oral steroids within 3 months

Baseline characteristics
  • Average age 45 years; female - 76%
  • Former smoker - 36%
  • FEV1: <60 - 15%, 60-79 - 37%, ≥80 - 48%
Group 1 (538 patients) - LABA + ICS

Group 2 (532 patients) - Tiotropium + ICS

  • ICS = Inhaled corticosteroid
  • LABA = Long-acting beta agonist
  • Patients continued on their current ICS
  • LABA was either salmeterol or formoterol
  • Study treatment was open-label
  • The primary outcome was time to asthma exacerbation, defined as an event of worsening asthma requiring oral or parenteral corticosteroids, such as an unscheduled physician visit, emergency department visit, hospitalization, or physician judgment of clinical asthma status over the follow-up duration of the study

  • The study also evaluated whether allelic variation at the Arg16Gly locus of the β2-adrenergic receptor (ADRB2) gene is associated with treatment response
After an average follow-up of 310 days, the following was seen:
  • Primary outcome: there was no significant difference between groups (p=0.47)
  • Average number of exacerbations per person-year: Group 1 - 0.42, Group 2 - 0.37 (rate ratio 0.90, [95% CI, 0.73 to 1.11], p=0.31)
  • Change in FEV₁ at 12 months: Group 1 - +0.003L, Group 2 - -0.018L (diff 0.020, 95%CI [−0.021 to 0.061], p=0.33)
  • Study discontinuation rates: Group 1 - 31%, Group 2 - 35% (p=0.12)
  • Arg16Gly ADRB2 alleles were not associated with differences in effects of either drug


Study Criteria Intervention Primary outcome Results

Tiotropium
vs
placebo
for poorly-controlled asthma



NEJM 2012

PubMed abstract
Inclusion criteria:
  • Age 18 - 75 years
  • Asthma for ≥ 5 years diagnosed before the age of 40
  • PFTs that demonstrated persistent airflow limitation despite LABA and ICS therapy
  • One exacerbation that was treated with systemic glucocorticoids in the previous year

Exclusion criteria:
  • History of COPD
  • ≥ 10 pack-year smoking history
  • Smoking in year prior to enrollment
Group 1 (456 patients) - Tiotropium Respimat® inhaler 2 puffs (5 mcg total) every morning for 48 weeks

Group 2 (456 patients) - Placebo inhaler

  • Inhalers were added to other meds. Doses of other meds were to remain stable during the trial.
  • Average baseline FEV₁ was 62% of predicted value
  • Average age of participants was 53 years
  • Lung function outcome - The two coprimary lung-function endpoints for each trial were the peak FEV₁ response (within 3 hours after administration of the maintenance and study drugs) and the trough FEV₁ response at week 24 — both expressed as the change from the baseline FEV₁.
  • Clinical outcome - time to the first severe asthma exacerbation defined as a deterioration of asthma necessitating initiation or at least a doubling of systemic glucocorticoids for ≥ 3 days (over 48 weeks)
Lung function outcome
The study included 2 separate trials with identical designs
  • In trial 1, the average peak FEV₁ difference in change from baseline was 86 ml greater in Group 1 (p=0.01)
  • In trial 2, the average peak FEV₁ difference in change from baseline was 154 ml greater in Group 1 (p<0.001)
  • In trial 1, the average trough FEV₁ difference in change from baseline was 88 ml greater in Group 1 (p=0.01)
  • In trial 2, the average trough FEV₁ difference in change from baseline was 111 ml greater in Group 1 (p<0.001)

Clinical outcome
Data from the 2 separate trials were combined for the clinical outcome
  • Patients in Group 1 averaged 282 days to first severe exacerbation compared to 226 days in Group 2
  • Risk of severe exacerbation in Group 1 compared to Group 2 was significantly reduced (HR 0.79; p=0.03)





Study Criteria Intervention Primary outcome Results

Tiotropium
vs
placebo
for COPD

UPLIFT Study



NEJM 2012

PubMed abstract
Inclusion criteria:
  • Smoking history of ≥ 10 pack-years
  • PFTs consistent with COPD

Exclusion criteria:
  • History of asthma
  • Use of supplemental oxygen for more than 12 hours per day
Group 1 (2986 patients) - Tiotropium 18 mcg via inhaler once daily

Group 2 (3006 patients) - Placebo inhaler

  • All other COPD meds, excluding inhaled anticholinergic agents, were allowed during the study
  • The primary endpoint was the yearly rate of decline in the average FEV₁
  • FEV₁ measurements were performed every 6 months. The measurements were taken before the use of a study drug and short-acting bronchodilators in the morning (prebronchodilator) and after the use of a study drug (postbronchodilator)
  • Measurements were started 30 days after the study drugs were initiated
Average annual rate of decline in FEV₁
  • Group 1 - prebronchodilation - 30 ml/yr
  • Group 1 - postbronchodilation - 40 ml/yr
  • Group 2 - prebronchodilation - 30 ml/yr
  • Group 2 - postbronchodilation - 42 ml/yr
  • Comparisons were nonsignificant

  • The median follow-up was 3.93 years in both groups
  • During the 30 day initiation period, the FEV₁ in Group 1 improved by 87 - 103 ml before bronchodilation and from 47 - 65 ml after bronchodilation when compared to Group 2. This difference was maintained throughout the study, but the rate of decline was the same.
  • There was no significant difference in overall mortality between the groups (Group 1 - 14.9%, Group 2 - 16.5%)
  • Group 1 had significantly fewer cardiac and lower respiratory adverse events



  • PRICING

    • $ = 0 - $50
    • $$ = $51 - $100
    • $$$ = $101 - $150
    • $$$$ = > $151

    • Pricing based on one month of therapy at standard dosing in an adult
    • Pricing based on survey of GoodRX.com®, HEB®, and Costco®, [accessed 1/2015]
    • Pricing may vary by region and availability




  • References:
  • 1 - NHLBI 2007 asthma guidelines
  • 2 - Manufacturer's package insert