INHALED CORTICOSTEROIDS









Beclomethasone (Qvar®)

Dosage form
Qvar® Redihaler 40
  • Delivers 40 mcg of beclomethasone per actuation
  • Comes in 10.6 g size with 120 actuations
  • Inhaler is breath-actuated
Qvar® Redihaler 80
  • Delivers 80 mcg of beclomethasone per actuation
  • Comes in 10.6 g size with 120 actuations
  • Inhaler is breath-actuated

Dosing - Asthma
4 - 11 years
  • Starting: 40 mcg twice a day
  • Max: 80 mcg twice a day
  • For patients who do not respond to 40 mcg after 2 weeks, the dose may be increased to 80 mcg
  • Do not use spacer or volume holding chamber with Redihaler
12 years and older
  • Starting: 40 - 80 mcg twice a day
  • Max: 320 mcg twice a day
  • Patients who are already using an inhaled corticosteroid may require higher starting doses
  • Increase dose at two-week intervals if necessary
  • Do not use spacer or volume holding chamber with Redihaler

Generic / Price - NO/$$$-$$$$
Other
  • Do not use spacer or volume holding chamber with Redihaler
  • Redihaler is breath-actuated meaning the inhaler releases medication when the patient takes a deep breath, and the patient does not need to push anything
  • Rinsing mouth after use may help prevent thrush

Mechanism of Action
  • Corticosteroid - has multiple anti-inflammatory effects; inhibits both inflammatory cells and release of inflammatory mediators

FDA-approved indications
Asthma
  • Patients 4 years of age and older
  • ICS are indicated for maintenance and prophylactic therapy
  • NOTE: ICS are NOT indicated for the relief of acute bronchospasm

Side effects

Side effect Qvar 320 mcg Placebo
Upper respiratory infection 4% 2%
Thrush 3% <1%
Nasopharyngitis 1% 1%
Mouth pain <1% <1%
Viral upper respiratory infection <1% 1%
Sinusitis <1% <1%
Other
  • Voice disorders - up to 50% of patients
  • Reflex cough and bronchospasm


Drug Interactions
  • CYP3A4 strong inhibitors - beclomethasone is a CYP3A4 substrate. Strong CYP3A4 inhibitors may increase systemic exposure to beclomethasone

Precautions/ Contraindications
  • Linear growth in children - long-term ICS use in children may inhibit linear growth. See linear growth in children for more.
  • Glaucoma - long-term ICS use may be associated with a higher risk of glaucoma
  • Cataracts - long-term ICS use may be associated with a higher risk of cataracts
  • Osteoporosis - long-term ICS use may be associated with a higher risk of osteoporosis
  • Hypothalamic-pituitary-adrenal (HPA) suppression - ICS may suppress the HPA axis. This is rare at typical doses.
  • Lung infections - Use with caution in patients with serious lung infections (e.g. tuberculosis, fungal infections, etc.)
  • Skin thinning and bruising - long-term ICS use may be associated with skin thinning and bruising
  • Liver disease - has not been studied extensively
  • Kidney disease - has not been studied extensively

Budesonide (Pulmicort®)

Dosage form
Pulmicort Flexhaler™
  • Pulmicort Flexhaler® 90 - contains 90 mcg of budesonide inhalation powder (60 actuations)
  • Pulmicort Flexhaler® 180 - contains 180 mcg of budesonide inhalation powder (120 actuations)
Pulmicort Respules® - nebulizer
  • 0.25 mg/2ml
  • 0.5 mg/2ml
  • 1 mg/2ml
  • 30 respules in a carton

Dosing - Flexhaler
Asthma (6 - 17 years)
  • Starting: 180 mcg twice a day
  • Max: 360 mcg twice a day
  • Rinsing mouth after use may help prevent thrush
Asthma (≥ 18 years)
  • Starting: 360 mcg twice a day
  • Max: 720 mcg twice a day
  • Rinsing mouth after use may help prevent thrush

Dosing - Respules
Asthma (1 - 8 years old)
  • Starting: 0.5 mg once daily or 0.25 mg twice a day
  • Max: 1 mg once daily or 0.5 mg twice a day
  • Rinsing mouth after use may help prevent thrush

Generic / Price
  • Inhaler - NO/$$$$
  • Respules (30 ampules) - YES/$$

Other
Pulmicort Respules®
  • Protect from sunlight
  • When an envelope has been opened, the shelf life of the unused ampules is 2 weeks when protected

Mechanism of Action
  • Corticosteroid - has multiple anti-inflammatory effects; inhibits both inflammatory cells and release of inflammatory mediators

FDA-approved indications
Asthma
  • Flexhaler™ - 6 years of age and older
  • Respules® - 12 months - 8 years of age
  • ICS are indicated for maintenance and prophylactic therapy
  • NOTE: ICS are NOT indicated for the relief of acute bronchospasm

Side effects

Side effect Budesonide Placebo
Nasopharyngitis 9.3% 8.3%
Nasal congestion 2.7% 0.4%
Pharyngitis 2.7% 1.7%
Allergic rhinitis 2.2% 1.3%
Viral upper respiratory infection 2.2% 1.3%
Nausea 1.8% 0.9%
Other
  • Thrush - up to 34% of patients
  • Voice disorders - up to 50% of patients
  • Reflex cough and bronchospasm


Drug Interactions
  • CYP3A4 strong inhibitors - budesonide is a CYP3A4 substrate. Strong CYP3A4 inhibitors may increase systemic exposure to budesonide

Precautions/Contraindications
  • Severe milk allergy - (Flexhaler® only) - DO NOT USE - contains small amount of lactose
  • Linear growth in children - long-term ICS use in children may inhibit linear growth. See linear growth in children for more.
  • Glaucoma - long-term ICS use may be associated with a higher risk of glaucoma
  • Cataracts - long-term ICS use may be associated with a higher risk of cataracts
  • Osteoporosis - long-term ICS use may be associated with a higher risk of osteoporosis
  • Hypothalamic-pituitary-adrenal (HPA) suppression - ICS may suppress the HPA axis. This is rare at typical doses.
  • Lung infections - Use with caution in patients with serious lung infections (e.g. tuberculosis, fungal infections, etc.)
  • Skin thinning and bruising - long-term ICS use may be associated with skin thinning and bruising
  • Liver disease - has not been studied extensively
  • Kidney disease - has not been studied extensively

Ciclesonide (Alvesco®)

Dosage form
Inhaler
  • Alvesco® 80 - delivers 80 mcg of ciclesonide per actuation
  • Alvesco® 160 - delivers 160 mcg of ciclesonide per actuation
  • Inhalers come with 60 actuations

Dosing
Asthma (12 years and older)
  • Starting: 80 mcg twice a day
  • Max: 320 mcg twice a day
  • Patients taking oral corticosteroids may require higher starting doses

Generic / Price - NO/$$$$
Other
  • Rinsing mouth after use may help prevent thrush
  • Prime inhaler before first dose by releasing 3 puffs into the air
  • Prime inhaler if not used for more than 10 days

Mechanism of Action
  • Corticosteroid - has multiple anti-inflammatory effects; inhibits both inflammatory cells and release of inflammatory mediators

FDA-approved indications
Asthma
  • Patients 12 years of age and older
  • ICS are indicated for maintenance and prophylactic therapy
  • NOTE: ICS are NOT indicated for the relief of acute bronchospasm

Side Effects

Side effect Ciclesonide Placebo
Headache 11% 7.3%
Nasopharyngitis 8.7% 7.5%
Upper respiratory infection 8.7% 6.5%
Sinusitis 5.5% 3%
Nasal congestion 5.5% 1.6%
Other
  • Thrush - up to 34% of patients
  • Voice disorders - up to 50% of patients
  • Reflex cough and bronchospasm


Drug Interactions
  • CYP3A4 strong inhibitors - ciclesonide is a CYP3A4 substrate. Strong CYP3A4 inhibitors may increase systemic exposure to ciclesonide

Precautions/Contraindications
  • Linear growth in children - long-term ICS use in children may inhibit linear growth. See linear growth in children for more.
  • Glaucoma - long-term ICS use may be associated with a higher risk of glaucoma
  • Cataracts - long-term ICS use may be associated with a higher risk of cataracts
  • Osteoporosis - long-term ICS use may be associated with a higher risk of osteoporosis
  • Hypothalamic-pituitary-adrenal (HPA) suppression - ICS may suppress the HPA axis. This is rare at typical doses.
  • Lung infections - Use with caution in patients with serious lung infections (e.g. tuberculosis, fungal infections, etc.)
  • Skin thinning and bruising - long-term ICS use may be associated with skin thinning and bruising
  • Liver disease - no dose adjustment necessary
  • Kidney disease - has not been studied extensively

Flunisolide (Aerospan™)

Dosage form
HFA inhaler
  • delivers 80 mcg of flunisolide per actuation
  • Inhaler comes with 120 actuations
  • Inhaler comes with built-in spacer

Dosing - Asthma
6 - 11 years
  • Starting: 80 mcg twice a day
  • Max: 160 mcg twice a day
12 years and older
  • Starting: 160 mcg twice a day
  • Max: 320 mcg twice a day

Generic / Price - NO/$$$$
Other
  • Aerospan™ comes with a built-in spacer
  • Rinsing mouth after use may help prevent thrush
  • Prime before using for the first time by releasing 2 test sprays into the air
  • Re-prime inhaler if not used for more than 2 weeks

Mechanism of Action
  • Corticosteroid - has multiple anti-inflammatory effects; inhibits both inflammatory cells and release of inflammatory mediators

FDA-approved indications
Asthma
  • Patients 6 years of age and older
  • ICS are indicated for maintenance and prophylactic therapy
  • NOTE: ICS are NOT indicated for the relief of acute bronchospasm

Side effects

Side effect Flunisolide Placebo
Pharyngitis 16.8% 13.2%
Sinusitis 8.8% 5.5%
Allergic reaction 4.4% 2.3%
Upset stomach 3.5% 1.4%
Other
  • Thrush - up to 34% of patients
  • Voice disorders - up to 50% of patients
  • Reflex cough and bronchospasm


Drug Interactions
  • CYP3A4 strong inhibitors - flunisolide is a CYP3A4 substrate. Strong CYP3A4 inhibitors may increase systemic exposure to flunisolide

Precautions/Contraindications
  • Linear growth in children - long-term ICS use in children may inhibit linear growth. See linear growth in children for more.
  • Glaucoma - long-term ICS use may be associated with a higher risk of glaucoma
  • Cataracts - long-term ICS use may be associated with a higher risk of cataracts
  • Osteoporosis - long-term ICS use may be associated with a higher risk of osteoporosis
  • Hypothalamic-pituitary-adrenal (HPA) suppression - ICS may suppress the HPA axis. This is rare at typical doses.
  • Lung infections - Use with caution in patients with serious lung infections (e.g. tuberculosis, fungal infections, etc.)
  • Skin thinning and bruising - long-term ICS use may be associated with skin thinning and bruising
  • Liver disease - has not been studied extensively
  • Kidney disease - has not been studied extensively

Fluticasone (ArmonAir®)

Dosage form
RespiClick powder inhaler
  • RespiClick® 55 - delivers 55 mcg of fluticasone propionate per inhalation
  • RespiClick® 113 - delivers 113 mcg of fluticasone propionate per inhalation
  • RespiClick® 232 - delivers 232 mcg of fluticasone propionate per inhalation
  • Each inhaler contains 60 actuations

Dosing - Asthma
12 years and older
  • Starting: 55 mcg twice daily
  • Maintenance: 55 - 232 mcg twice daily
  • Max: 232 mcg twice daily
  • Increase dose at intervals of 2 weeks
  • Inhale at the same time each day
  • Patients switching from other inhaled corticosteroids may require higher starting doses

Generic / Price - NO/$$$$
Other
  • Inhaler does not require priming
  • Never wash or put any part of the inhaler in water
  • Do not use with a spacer or volume holding chamber

Mechanism of Action
  • Corticosteroid - has multiple anti-inflammatory effects; inhibits both inflammatory cells and release of inflammatory mediators

FDA-approved indications
Asthma
  • Patients ≥ 12 years of age
  • ICS are indicated for maintenance and prophylactic therapy
  • NOTE: ICS are NOT indicated for the relief of acute bronchospasm

Side effects

Side effect Fluticasone 232 mcg Placebo
Nasopharyngitis 4.8% 4.4%
Upper respiratory infection 5.5% 4.8%
Oral candidiasis 4.8% 0.7%
Headache 4.8% 4.4%
Cough 3.4% 2.6%
Other
  • Voice disorders - up to 50% of patients
  • Reflex cough and bronchospasm


Drug Interactions
  • CYP3A4 strong inhibitors - fluticasone is a CYP3A4 substrate. Strong CYP3A4 inhibitors may increase systemic exposure to fluticasone

Precautions/Contraindications
  • Severe milk allergy - DO NOT USE - contains small amount of lactose
  • Linear growth in children - long-term ICS use in children may inhibit linear growth. See linear growth in children for more.
  • Glaucoma - long-term ICS use may be associated with a higher risk of glaucoma
  • Cataracts - long-term ICS use may be associated with a higher risk of cataracts
  • Osteoporosis - long-term ICS use may be associated with a higher risk of osteoporosis
  • Hypothalamic-pituitary-adrenal (HPA) suppression - ICS may suppress the HPA axis. This is rare at typical doses.
  • Lung infections and serious infections - Use with caution in patients with serious lung infections (e.g. tuberculosis, fungal infections, etc.) and/or serious systemic infections
  • Hypersensitivity reactions - serious hypersensitivity reactions including anaphylaxis have occurred with ICS
  • Paradoxical bronchospasm - paradoxical bronchospasm may occur after dosing
  • Eosinophilic Conditions and Churg-Strauss Syndrome - In rare cases, ICS use has been associated with eosinophilic conditions and Churg-Strauss Syndrome. Symptoms include eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy.
  • Liver disease - systemic exposure is likely increased. Use with caution.
  • Kidney disease - has not been studied

Fluticasone (Arnuity Ellipta®)

Dosage form
Inhalation powder
  • Arnuity™ Ellipta® 100 - delivers 100 mcg of fluticasone furoate per inhalation
  • Arnuity™ Ellipta® 200 - delivers 200 mcg of fluticasone furoate per inhalation
  • Inhaler contains 30 doses

Dosing - Asthma
12 years and older
  • Starting: 100 mcg once daily
  • Maintenance: 100 - 200 mcg once daily
  • Max: 200 mcg once daily
  • Increase dose at intervals of 2 weeks
  • Inhale at the same time every day

Generic / Price - NO/$$$$
Other
  • Rinsing mouth after use may help prevent thrush
  • Protect from direct heat and sunlight
  • Discard Arnuity™ Ellipta® inhaler 6 weeks after opening foil tray

Mechanism of Action
  • Corticosteroid - has multiple anti-inflammatory effects; inhibits both inflammatory cells and release of inflammatory mediators

FDA-approved indications
Asthma
  • Patients ≥ 12 years of age
  • ICS are indicated for maintenance and prophylactic therapy
  • NOTE: ICS are NOT indicated for the relief of acute bronchospasm

Side effects

Side effect Arnuity Ellipta Placebo
Nasopharyngitis 8% 5%
Bronchitis 7% 6%
Headache 6% 4%
Upper respiratory infection 6% 5%
Pharyngitis 4% 3%
Sinusitis 4% < 1%
Oropharyngeal pain 3% 0%
Other
  • Thrush - up to 34% of patients
  • Voice disorders - up to 50% of patients
  • Reflex cough and bronchospasm


Drug Interactions
  • CYP3A4 strong inhibitors - fluticasone is a CYP3A4 substrate. Strong CYP3A4 inhibitors may increase systemic exposure to fluticasone

Precautions/Contraindications
  • Severe milk allergy - DO NOT USE - contains small amount of lactose
  • Linear growth in children - long-term ICS use in children may inhibit linear growth. See linear growth in children for more.
  • Glaucoma - long-term ICS use may be associated with a higher risk of glaucoma
  • Cataracts - long-term ICS use may be associated with a higher risk of cataracts
  • Osteoporosis - long-term ICS use may be associated with a higher risk of osteoporosis
  • Hypothalamic-pituitary-adrenal (HPA) suppression - ICS may suppress the HPA axis. This is rare at typical doses.
  • Lung infections - Use with caution in patients with serious lung infections (e.g. tuberculosis, fungal infections, etc.)
  • Skin thinning and bruising - long-term ICS use may be associated with skin thinning and bruising
  • Liver disease - systemic exposure is increased; use with caution in moderate-to-severe liver disease
  • Kidney disease - no dose adjustment necessary

Fluticasone (Flovent®)

Dosage form
Flovent® HFA inhaler
  • Flovent® 44 - 44 mcg per actuation
  • Flovent® 110 - 110 mcg per actuation
  • Flovent® 220 - 220 mcg per actuation
  • HFAs have 120 actuations
Flovent® Diskus - inhalation powder
  • Flovent® Diskus 50 - 50 mcg per actuation
  • Flovent® Diskus 100 - 100 mcg per actuation
  • Flovent® Diskus 250 - 250 mcg per actuation
  • Diskus have 60 actuations

Dosing - Flovent HFA
Asthma (4 - 11 years)
  • Dosing: 88 mcg twice a day
Asthma (12 years and older)
  • Starting: 88 mcg twice a day
  • Max: 880 mcg twice a day
  • Maximum benefit seen after 2 weeks

Dosing - Flovent Diskus
Asthma (4 - 11 years)
  • Starting: 50 mcg twice a day
  • Max: 100 mcg twice a day
  • Maximum benefit seen after 2 weeks
Asthma (12 years and older)
  • Starting: 100 mcg twice a day
  • Max: 1000 mcg twice a day
  • Maximum benefit seen after 2 weeks

Efficacy
Generic / Price - NO/$$$-$$$$
Other
Flovent® HFA
  • Shake well before using
  • Rinsing mouth after use may help prevent thrush
  • Prime before using for the first time by releasing 4 test sprays into the air
  • Re-prime inhaler with 1 test spray if not used for more than 7 days or if dropped
Flovent® Diskus
  • Protect from light
  • Rinsing mouth after use may help prevent thrush
  • Diskus should be discarded 6 weeks (50 mcg strength) or 2 months (100 and 250 mcg strengths) after removal from the moisture-protective foil pouch

Mechanism of Action
  • Corticosteroid - has multiple anti-inflammatory effects; inhibits both inflammatory cells and release of inflammatory mediators

FDA-approved indications
Asthma
  • Patients 4 years of age and older
  • ICS are indicated for maintenance and prophylactic therapy
  • NOTE: ICS are NOT indicated for the relief of acute bronchospasm

Side effects

Side effect Flovent HFA Placebo
Upper respiratory infection 16% 14%
Throat irritation 8% 5%
Sinusitis 7% 3%
Headache 7% 6%
Upper respiratory infection 16% 14%
Other
  • Thrush - up to 34% of patients
  • Voice disorders - up to 50% of patients
  • Reflex cough and bronchospasm


Drug Interactions
  • CYP3A4 strong inhibitors - fluticasone is a CYP3A4 substrate. Strong CYP3A4 inhibitors may increase systemic exposure to fluticasone

Precautions/Contraindications
  • Severe milk allergy - (Flovent Diskus® only) - DO NOT USE - contains small amount of lactose
  • Linear growth in children - long-term ICS use in children may inhibit linear growth. See linear growth in children for more.
  • Glaucoma - long-term ICS use may be associated with a higher risk of glaucoma
  • Cataracts - long-term ICS use may be associated with a higher risk of cataracts
  • Osteoporosis - long-term ICS use may be associated with a higher risk of osteoporosis
  • Hypothalamic-pituitary-adrenal (HPA) suppression - ICS may suppress the HPA axis. This is rare at typical doses.
  • Lung infections - Use with caution in patients with serious lung infections (e.g. tuberculosis, fungal infections, etc.)
  • Skin thinning and bruising - long-term ICS use may be associated with skin thinning and bruising
  • Liver disease - has not been studied extensively
  • Kidney disease - has not been studied extensively

Mometasone (Asmanex®)

Dosage form
Asmanex Twisthaler® - inhalation powder
  • Asmanex® 110 - 100 mcg per actuation
  • Asmanex® 220 - 200 mcg per actuation
  • Asmanex® 110 - 30 actuation inhaler
  • Asmanex® 220 - 30, 60, and 120 actuation inhalers

Dosing - Asthma
12 years and older
  • Starting: 200 mcg twice a day
  • Max: 400 mcg twice a day
  • Titrate dose at intervals of 2 weeks

Generic / Price - NO/$$$$
Other
  • Rinsing mouth after use may help prevent thrush
  • Discard the inhaler 45 days after opening the foil pouch

Mechanism of Action
  • Corticosteroid - has multiple anti-inflammatory effects; inhibits both inflammatory cells and release of inflammatory mediators

FDA-approved indications
Asthma
  • Patients 4 years of age and older
  • ICS are indicated for maintenance and prophylactic therapy
  • NOTE: ICS are NOT indicated for the relief of acute bronchospasm

Side effects

Side effect Mometasone Placebo
Headache 17% 20%
Allergic rhinitis 11% 13%
Pharyngitis 8% 7%
Upper respiratory infection 8% 7%
Sinusitis 6% 5%
Other
  • Thrush - up to 34% of patients
  • Voice disorders - up to 50% of patients
  • Reflex cough and bronchospasm


Drug Interactions
  • CYP3A4 strong inhibitors - mometasone is a CYP3A4 substrate. Strong CYP3A4 inhibitors may increase systemic exposure to mometasone

Precautions/Contraindications
  • Severe milk allergy - DO NOT USE - contains small amount of lactose
  • Linear growth in children - long-term ICS use in children may inhibit linear growth. See linear growth in children for more.
  • Glaucoma - long-term ICS use may be associated with a higher risk of glaucoma
  • Cataracts - long-term ICS use may be associated with a higher risk of cataracts
  • Osteoporosis - long-term ICS use may be associated with a higher risk of osteoporosis
  • Hypothalamic-pituitary-adrenal (HPA) suppression - ICS may suppress the HPA axis. This is rare at typical doses.
  • Lung infections - Use with caution in patients with serious lung infections (e.g. tuberculosis, fungal infections, etc.)
  • Skin thinning and bruising - long-term ICS use may be associated with skin thinning and bruising
  • Liver disease - has not been studied extensively
  • Kidney disease - has not been studied extensively



Advair® | Salmeterol + Fluticasone

Dosage form
Advair® Diskus (fluticasone/salmeterol)
  • Advair® 100/50 - 100/50 mcg per inhalation
  • Advair® 250/50 - 250/50 mcg per inhalation
  • Advair® 500/50 - 500/50 mcg per inhalation
  • Inhalation powder packaged in diskus with 60 doses
Advair® HFA (fluticasone/salmeterol)
  • Advair HFA® 45/21 - 45/21 mcg per actuation
  • Advair HFA® 115/21 - 115/21 mcg per actuation
  • Advair HFA® 230/21 - 230/21 mcg per actuation
  • Inhaler with 120 actuations per inhaler

Dosing - Advair® Diskus
Asthma
  • 4 - 11 years old
    • One inhalation of 100/50 twice daily
  • 12 years of age and older
    • Dose: one inhalation twice daily
    • Starting: strength will depend on asthma severity
    • Max dose: 500/50, one inhalation twice daily
    • Maximum benefit seen after 2 weeks
COPD
  • 1 inhalation of 250/50 twice daily

Dosing - Advair® HFA
Asthma in children ≥ 12 years and adults
  • Dose: two inhalations twice daily
  • Starting: strength will depend on asthma severity
  • Max dose: 230/21, two inhalations twice daily
  • Maximum benefit seen after 2 weeks

Efficacy
Generic / Price
  • Diskus - YES/$$$
  • HFA - NO/$$$$

Other
Advair® HFA
  • Shake well for 5 seconds before use
  • Prime before using for the first time by releasing 4 test sprays
  • In cases where the inhaler has not been used for more than 4 weeks or when it has been dropped, prime the inhaler again by releasing 2 test sprays
  • Rinse mouth after use
Advair® Diskus
  • The device should be discarded 1 month after removal from the moisture-protective foil overwrap pouch
  • Rinse mouth after use

FDA-approved indications
Advair® Diskus
  • Asthma in children ≥ 4 years and adults
  • Chronic Obstructive Pulmonary Disease (COPD)
  • NOT for relief of acute bronchospasm
Advair® HFA
  • Asthma in children ≥ 12 years and adults
  • NOT for relief of acute bronchospasm

AirDuo RespiClick® | Salmeterol + fluticasone

Dosage form
Powder inhaler (fluticasone/salmeterol)
  • AirDuo RespiClick® 55/14 - 55/14 mcg per inhalation
  • AirDuo RespiClick® 113/14 - 113/14 mcg per inhalation
  • AirDuo RespiClick® 232/14 - 232/14 mcg per inhalation
  • Each inhaler contains 60 actuations

Dosing - Asthma
12 years of age and older
  • Starting: 55/14 mcg twice daily
  • Maintenance: 55/14 - 232/14 mcg twice daily
  • Max dose: 232/14 mcg twice daily
  • Increase dose at intervals of 2 weeks
  • Inhale at the same time each day
  • Patients switching from other inhaled corticosteroids may require higher starting doses

Generic / Price - YES/$$
Other
  • Inhaler does not require priming
  • Never wash or put any part of the inhaler in water
  • Do not use with a spacer or volume holding chamber

FDA-approved indications
  • Asthma in children ≥ 12 years and adults
  • NOT for relief of acute bronchospasm

Breo Ellipta® | Vilanterol + fluticasone

Dosage form
Inhaler
  • Inhaler delivers 100 mcg of fluticasone powder and 25 mcg of vilanterol powder per inhalation
  • Inhaler comes with 30 inhalations

Dosing
COPD
  • One inhalation once daily
Asthma (≥ 18 years old)
  • One inhalation once daily

Generic / Price - NO/$$$$
Other
  • See Breo 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.

FDA-approved indications
  • Maintenance treatment of Chronic Obstructive Pulmonary Disease (COPD)
  • Asthma in patients ≥ 18 years old that is not well-controlled with other medications
  • NOT for relief of acute bronchospasm

Dulera® | Formoterol + Mometasone

Dosage form
Inhaler (mometasone/formoterol)
  • Dulera® 100/5 - 100 mcg/5 mcg per actuation
  • Dulera® 200/5 - 200 mcg/5 mcg per actuation
  • Comes in inhaler with 120 actuations

Dosing - Asthma
12 years of age and older
  • Dose: 2 inhalations twice daily
  • Medium dose corticosteroids: Dulera® 100 mcg/5 mcg, two inhalations twice daily
  • High dose corticosteroids: Dulera® 200 mcg/5 mcg, two inhalations twice daily
  • Maximum benefit seen after 2 weeks

Generic / Price - NO/$$$$
Other
  • Shake well before use
  • Prime inhaler by releasing 4 test sprays
  • Re-prime if not used for ≥ 5 days

FDA-approved indications
  • Maintenance treatment of Asthma
  • NOT for relief of acute bronchospasm

Symbicort® | Formoterol + Budesonide

Dosage form
Inhaler (budesonide/formoterol)
  • Symbicort® 80/4.5 - 80 mcg/4.5 mcg per actuation
  • Symbicort® 160/4.5 - 160 mcg/4.5 mcg per actuation
  • Comes in inhaler with 120 actuations

Dosing - Asthma
6 to 11 years old
  • Dose: Symbicort 80/4.5 two inhalations twice daily
12 years of age and older
  • Dose: two inhalations twice daily
  • Starting - may start with 80/4.5 or 160/4.5, depending on severity
  • Max: Symbicort 160/4.5 two inhalations twice daily
  • Maximum benefit seen after 2 weeks

Dosing - COPD
  • For patients with COPD, the recommended dose is Symbicort 160/4.5 two inhalations twice daily

Generic / Price - NO/$$$$
Other
  • Shake well for 5 seconds before use
  • Inhaler is good for 3 months after removal from foil pouch
  • If you do not use your inhaler for more than 7 days or if you drop it, you will need to prime again
  • See patient instructions for details

FDA-approved indications
  • Maintenance treatment of Asthma
  • Maintenance treatment of Chronic Obstructive Pulmonary Disease (COPD)
  • NOT for relief of acute bronchospasm



Trelegy Ellipta® | Fluticasone + vilanterol + umeclidinium

Dosage form
Inhaler
  • Inhaler delivers 100 mcg of fluticasone, 62.5 mcg of umeclidinium, and 25 mcg of vilanterol powder per inhalation
  • Inhaler comes with 30 inhalations

Dosing
COPD
  • One inhalation once daily

Generic / Price - NO/$$$$
Other
  • See Trelegy 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.

FDA-approved indication
  • Maintenance treatment of Chronic Obstructive Pulmonary Disease (COPD)
  • NOT for relief of acute bronchospasm









Asthma studies

Quintupled ICS Dose vs Maintenance Dose at Signs of Exacerbation, NEJM (2018) [PubMed abstract]
  • Design: Randomized, placebo-controlled trial (N=254 | length = 48 weeks) in children with mild-to-moderate persistent asthma on ICS maintenance therapy
  • Treatment: Quintupled ICS Dose vs Normal Dose + Placebo for 7 days at signs of exacerbation
  • Primary outcome: Rate of severe asthma exacerbations treated with systemic glucocorticoids
  • Results:
    • Primary outcome (exacerbations/yr): Quintupled dose - 0.48, Placebo - 0.37 (p=0.30)
  • Findings: In children with mild-to-moderate persistent asthma treated with daily inhaled glucocorticoids, quintupling the dose at the early signs of loss of asthma control did not reduce the rate of severe asthma exacerbations or improve other asthma outcomes and may be associated with diminished linear growth.

Open-label Quadrupling ICS Dose vs Maintenance Dose at Signs of Exacerbation, NEJM (2018) [PubMed abstract]
  • Design: Randomized, open-label, pragmatic trial (N=1922 | length = 12 months) in adults and adolescents with asthma on ICS maintenance therapy
  • Treatment: Quadrupled ICS Dose vs Maintenance Dose at signs of exacerbation
  • Primary outcome: Time to a first severe asthma exacerbation, defined as treatment with systemic glucocorticoids or an unscheduled health care consultation for asthma
  • Results:
    • Primary outcome (severe exacerbation): Quadrupled dose - 45%, Maintenance dose - 52% (p=0.002)
  • Findings: In this trial involving adults and adolescents with asthma, a personalized self-management plan that included a temporary quadrupling of the dose of inhaled glucocorticoids when asthma control started to deteriorate resulted in fewer severe asthma exacerbations than a plan in which the dose was not increased

Budesonide-Formoterol as needed vs Daily Budesonide for Preventing Asthma Exacerbations, NEJM (2018) [PubMed abstract]
  • Design: Randomized, placebo-controlled trial (N=4215 | length = 52 weeks) in patients ≥ 12 years old with mild asthma
  • Treatment: Budesonide-Formoterol at signs of exacerbation vs Maintenance Budesonide
  • Primary outcome: Annualized rate of severe exacerbations
  • Results:
    • Primary outcome (exacerbation/yr): Budesonide-Formoterol - 0.11, Maintenance budesonide - 0.12
  • Findings: In patients with mild asthma, budesonide-formoterol used as needed was noninferior to twice-daily budesonide with respect to the rate of severe asthma exacerbations during 52 weeks of treatment but was inferior in controlling symptoms. Patients in the budesonide-formoterol group had approximately one quarter of the inhaled glucocorticoid exposure of those in the budesonide maintenance group.

LABA vs LAMA added to ICS in Black Adults with Asthma , JAMA (2015) [PubMed abstract]
  • Design: Randomized, open-label trial (N=1070 | length = 18 months) in black adults with moderate to severe asthma
  • Treatment: Once-daily Tiotropium vs Twice-daily LABA in patients using an ICS
  • Primary outcome: Time to asthma exacerbation, defined as a worsening asthma event requiring oral or parenteral corticosteroids
  • Results:
    • Primary outcome (mean exacerbation/person-year): Tiotropium - 0.37, LABA - 0.42 (p=0.31)
    • There was no difference in change in FEV1 at 12 months
  • Findings: Among black adults with asthma treated with ICS, adding a LABA did not improve time to asthma exacerbation compared with adding tiotropium. These findings were not affected by polymorphisms at the Arg16Gly locus of ADRB2. These findings do not support the superiority of LABA + ICS compared with tiotropium + ICS for black patients with asthma.

LABA/ICS vs Doubling ICS in Children with Symptomatic Asthma - Am J Respir Crit Care Med (2010) [PubMed abstract]
  • Design: Randomized, controlled trial (N=158 | length = 26 weeks) in children with symptomatic asthma on Fluticasone 100 twice a day
  • Treatment: Salmeterol/Fluticasone 50/100 twice a day vs Fluticasone 200 twice a day
  • Primary outcome: Percentage of symptom-free days during the last 10 weeks of the treatment. Change in lung function measurements
  • Results:
    • Percentage of symptom-free days during the last 10 weeks of the treatment period did not differ between treatment groups (per protocol analysis: adjusted mean difference 2.6%; 95% confidence interval, -8.1 to 13.4)
  • Findings: In our study, the efficacy on symptom control and lung function of the combination of a long-acting bronchodilator with inhaled corticosteroid is equal to doubling the dose of the inhaled corticosteroid in children still symptomatic on a moderate dose of inhaled corticosteroid.

ICS vs ICS/LABA vs ICS/LTRA in Children with Uncontrolled Asthma, NEJM (2010) [PubMed abstract]
  • Design: Randomized, crossover trial (N=182 | length = 16 weeks on each regimen) in children with uncontrolled asthma on Fluticasone 100 twice daily
  • Treatment: Fluticasone 250 twice daily vs Salmeterol/Fluticasone 50/100 twice daily vs Fluticasone 100 twice daily + Montelukast 5 - 10 mg once daily
  • Primary outcome: The primary outcome was the differential response to each of the three step-up therapies on the basis of fixed threshold criteria for the following three asthma-control measures: the need for treatment with oral prednisone for acute asthma exacerbations, the number of asthma control days, and the FEV1.
  • Results:
    • Salmeterol/Fluticasone was more likely to be the best response when compared to Fluticasone (p-value=0.002) and Fluticasone + Montelukast (p-value=0.004)
    • There was no significant difference between Fluticasone and Fluticasone + Montelukast
    • White race predicted a better response to Salmeterol/Fluticasone
    • Black patients were least likely to have a best response to Fluticasone + Montelukast
  • Findings: Nearly all the children had a differential response to each step-up therapy. LABA step-up was significantly more likely to provide the best response than either ICS or LTRA step-up. However, many children had a best response to ICS or LTRA step-up therapy, highlighting the need to regularly monitor and appropriately adjust each child's asthma therapy.

LABA vs LTRA Added to ICS in Uncontrolled Asthma, BMJ (2003) [PubMed abstract]
  • Design: Randomized, placebo-controlled trial (N=1490 | length = 52 weeks) in patients with uncontrolled asthma
  • Treatment: Fluticasone 100 mcg twice daily + Montelukast 10 mg once daily or Salmeterol 50 mcg twice daily
  • Primary outcome: The primary endpoint was the percentage of patients with at least one asthma exacerbation. Asthma exacerbation was defined as worsening asthma requiring an unscheduled visit to a doctor, emergency department, or hospital or treatment with oral, intravenous, or intramuscular corticosteroids
  • Results:
    • Primary outcome: Montelukast - 20.1%, Salmeterol - 19.1% (diff 1%, 95%CI [-3.1% to 5%])
    • The Salmeterol group had a significantly greater increase in FEV₁ than the Montelukast group (p-value<0.001)
  • Findings: The addition of montelukast in patients whose symptoms remain uncontrolled by inhaled fluticasone could provide equivalent clinical control to salmeterol

FLAME study - Indacaterol–Glycopyrronium vs Salmeterol–Fluticasone for COPD, NEJM (2016) [PubMed abstract]
  • The FLAME study enrolled 3362 patients with COPD
Main inclusion criteria
  • COPD with ≥ 1 exacerbation in last year
  • Smoking history of ≥ 10 pack-years
  • Post-bronchodilator FEV₁ 25% - 60% of predicted value
  • Post-bronchodilator FEV₁/FVC < 0.70
Main exclusion criteria
  • Long QT syndrome or QTc > 450 ms
  • Narrow-angle glaucoma
  • Symptomatic benign prostatic hyperplasia
  • Requiring O₂ therapy for > 12 hours a day
Baseline characteristics
  • Average age 64 years
  • Average duration of COPD - 7.3 years
  • Using inhaled glucocorticoids - 56%
  • Current smoker - 40%
  • Average post-bronchodilator FEV₁ % of predicted - 44%
  • Average post-bronchodilator FEV₁/FVC - 0.416
Randomized treatment groups
  • Group 1 (1680 patients) - Indacaterol 110 μg + glycopyrronium 50 μg once daily for 52 weeks
  • Group 2 (1682 patients) - Salmeterol 50 μg + fluticasone 500 μg twice daily for 52 weeks
  • Before the treatment phase, patients were entered into a 4-week run-in period with tiotropium only. After the run-in phase, patients were randomized to study treatment and all other preventative inhalers were prohibited. Open-label salbutamol (100 μg) was provided as rescue medication.
  • Treatment was given as double dummy inhalers
Primary outcome: Annual rate of all COPD exacerbations (mild, moderate, or severe). COPD exacerbations were defined as mild (involving worsening of symptoms for > 2 consecutive days but not leading to treatment with systemic glucocorticoids or antibiotics), moderate (leading to treatment with systemic glucocorticoids, antibiotics, or both), or severe (leading to hospital admission or a visit to the emergency department that lasted > 24 hours in addition to treatment with systemic glucocorticoids, antibiotics, or both).
Results

Duration: 52 weeks
Outcome LABA/LAMA LABA/ICS Comparisons
Primary outcome (annual rate of exacerbations) 3.59 4.09 Rate ratio 0.88, 95%CI [0.82 - 0.94], p<0.001
Median time to first exacerbation 71 days 51 days HR 0.84, 95%CI [0.78 - 0.91]. p<0.001
Annual rate of moderate or severe exacerbations 0.98 1.19 HR 0.83, 95%CI [0.75 - 0.91]. p<0.001
Pneumonia 3.2% 4.8% p=0.02
Oral candidiasis 1.2% 4.2% N/A
  • The standardized area under the curve for FEV₁ from 0 to 12 hours was measured in a subgroup of 556 patients; the change from baseline was significantly greater in Group 1 than in Group 2, with a between-group difference of 110 ml at week 52 (P<0.001)
  • The median percentage change over a period of 52 weeks in the ratio of 24-hour urinary cortisol to creatinine was +5.62% in Group 1 and –10.39% in Group 2
  • In a subgroup analysis, indacaterol–glycopyrronium was superior to salmeterol–fluticasone regardless of baseline eosinophil count (< 2% vs > 2%)

Findings: Indacaterol-glycopyrronium was more effective than salmeterol-fluticasone in preventing COPD exacerbations in patients with a history of exacerbation during the previous year
StraightHealthcare analysis:
  • The FLAME study found that the addition of an inhaled anticholinergic was more effective than an inhaled corticosteroid in patients with COPD who were receiving a long-acting beta agonist
  • Anticholinergics were superior across a broad array of outcome measures. They also carried a significantly lower risk of pneumonia.

LABA/ICS vs LABA vs ICS vs Placebo in patients with COPD - NEJM (2007) [PubMed abstract]
  • Design: Randomized, placebo-controlled trial (N=6112 | length = 3 years) in patients with COPD
  • Treatment: Salmeterol/Fluticasone 50/500 twice daily vs Salmeterol 50 twice daily vs Fluticasone 500 twice daily vs Placebo
  • Primary outcome: The primary outcome was death from any cause over three years of follow-up
  • Results:
    • Primary outcome: Salmeterol/Fluticasone - 12.6%, Salmeterol - 13.5%, Fluticasone - 16%, Placebo - 15.2%
    • All comparisons were nonsignificant except for Salmeterol/Fluticasone vs Fluticasone (p=0.007)
  • Findings: The reduction in death from all causes among patients with COPD in the combination-therapy group did not reach the predetermined level of statistical significance. There were significant benefits in all other outcomes among these patients.



Pricing legend
  • $ = 0 - $50
  • $$ = $51 - $100
  • $$$ = $101 - $150
  • $$$$ = > $151
  • Pricing based on one month of therapy at standard dosing in an adult
  • Pricing based on information from GoodRX.com®
  • Pricing may vary by region and availability