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    INHALED CORTICOSTEROIDS (ICS)
    • NOTE: This page is intended to be a quick reference for properties of commonly used inhaled corticosteroids. It is NOT a comprehensive review of each medication. Other drug interactions, side effects, precautions, and contraindications may exist for each drug.

Inhaled corticosteroids (ICS) Long-acting beta agonist + inhaled corticosteroid ICS dosing chart
Other

Asthma studies COPD studies




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
Beclomethasone

(Qvar®)
Qvar® 40 inhaler
  • Delivers 40mcg of beclomethasone per actuation
  • Available as 100 (7.3g) or 120 actuations (8.7g) per inhaler

Qvar® 80 inhaler
  • Delivers 80mcg of beclomethasone per actuation
  • Available as 100 (7.3g) or 120 actuations (8.7g) per inhaler
See Asthma dosing chart below NO/$$-$$$$
  • A spacer may help prevent thrush

  • Rinsing mouth after use may help prevent thrush
  • Corticosteroid - has multiple anti-inflammatory effects; inhibits both inflammatory cells and release of inflammatory mediators
Asthma
  • Patients 5 years of age and older
  • ICS are indicated for maintenance and prophylactic therapy
  • NOTE: ICS are NOT indicated for the relief of acute bronchospasm
All ICS
  • Thrush - up to 34% of patients
  • Voice disorders - up to 50% of patients
  • Reflex cough and bronchospasm

From the Qvar® PI
  • Upper respiratory infection - 11%, P - 11%
  • Headache- 8%, P - 9%
  • Pharyngitis - 5%, P - 4%
  • Oral symptoms - 3%, P - 2%
  • Sinusitis- 3%, P - 2%
  • Nausea- 1%, P - 0%
  • CYP3A4 strong inhibitors - beclomethasone is a CYP3A4 substrate. Strong CYP3A4 inhibitors may increase systemic exposure to beclomethasone
  • Linear growth in children - long-term ICS use in children may inhibit linear growth
  • 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

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
Budesonide

(Pulmicort®)



Symbicort®

(budesonide + formoterol)
Pulmicort Flexhaler™
  • Pulmicort Flexhaler® 90 - contains 90mcg of budesonide inhalation powder (60 actuations)
  • Pulmicort Flexhaler® 180 - contains 180mcg of budesonide inhalation powder (120 actuations)

Pulmicort Respules® - nebulizer
  • 0.25mg/2ml
  • 0.5mg/2ml
  • 1mg/2ml
  • 30 respules in a carton
See Asthma dosing chart below Inhaler
NO/$$$-$$$$

Respules
YES/$$$$
Pulmicort Flexhaler™
  • Rinsing mouth after use may help prevent thrush

Pulmicort Respules®
  • Protect from sunlight

  • When an envelope has been opened, the shelf life of the unused ampules is 2 weeks when protected

  • Rinsing mouth after use may help prevent thrush

  • Corticosteroid - has multiple anti-inflammatory effects; inhibits both inflammatory cells and release of inflammatory mediators
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
All ICS
  • Thrush- up to 34% of patients
  • Voice disorders - up to 50% of patients
  • Reflex cough and bronchospasm

From the Flexhaler® PI
  • Nasopharyngitis - 9.3%, P - 8.3%
  • Nasal congestion - 2.7%, P - 0.4%
  • Pharyngitis- 2.7%, P - 1.7%
  • Allergic rhinitis - 2.2%, P - 1.3%
  • Viral upper respiratory infection - 2.2%, P - 1.3%
  • Nausea - 1.8%, P - 0.9%
  • CYP3A4 strong inhibitors - budesonide is a CYP3A4 substrate. Strong CYP3A4 inhibitors may increase systemic exposure to budesonide
  • 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
  • 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

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
Ciclesonide

(Alvesco®)
Alvesco® inhaler
  • Alvesco® 80 - delivers 80mcg of ciclesonide per actuation
  • Alvesco® 160 - delivers 160mcg of ciclesonide per actuation
  • Inhalers come with 60 actuations
See Asthma dosing chart below NO/$$$$
  • 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
  • Corticosteroid - has multiple anti-inflammatory effects; inhibits both inflammatory cells and release of inflammatory mediators
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
All ICS
  • Thrush - up to 34% of patients
  • Voice disorders - up to 50% of patients
  • Reflex cough and bronchospasm

From the Alvesco® PI
  • Headache- 11%, P - 7.3%
  • Nasopharyngitis - 8.7%, P - 7.5%
  • Upper respiratory infection - 8.7%, P - 6.5%
  • Sinusitis - 5.5%, P - 3%
  • Nasal congestion - 5.5%, P - 1.6%
  • CYP3A4 strong inhibitors - ciclesonide is a CYP3A4 substrate. Strong CYP3A4 inhibitors may increase systemic exposure to ciclesonide
  • Linear growth in children - long-term ICS use in children may inhibit linear growth
  • 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

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
Flunisolide

(Aerospan™)
Aerospan™ HFA
  • delivers 80mcg of flunisolide per actuation
  • Inhaler comes with 120 actuations
  • Inhaler comes with built-in spacer
See Asthma dosing chart below
  • NO/$$$$
  • 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
  • Corticosteroid - has multiple anti-inflammatory effects; inhibits both inflammatory cells and release of inflammatory mediators
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
All ICS
  • Thrush - up to 34% of patients
  • Voice disorders - up to 50% of patients
  • Reflex cough and bronchospasm

From the Aerospan™ PI
  • Pharyngitis- 16.8%, P - 13.2%
  • Sinusitis- 8.8%, P - 5.5%
  • Allergic reaction - 4.4%, P - 2.3%
  • Upset stomach- 3.5%, P - 1.4%
  • CYP3A4 strong inhibitors - flunisolide is a CYP3A4 substrate. Strong CYP3A4 inhibitors may increase systemic exposure to flunisolide
  • Linear growth in children - long-term ICS use in children may inhibit linear growth
  • 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

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
Fluticasone
furoate

(Arnuity™ Ellipta®)


Breo® Ellipta®

(fluticasone + vilanterol)
Arnuity™ Ellipta® - inhalation powder
  • Arnuity™ Ellipta® 100 - delivers 100mcg of fluticasone furoate per inhalation
  • Arnuity™ Ellipta® 200 - delivers 200mcg of fluticasone furoate per inhalation
  • Inhaler contains 30 doses
Asthma
  • Starting: 100mcg once daily
  • Maintenance: 100 - 200mcg once daily
  • Max: 200mcg once daily
  • Increase dose at intervals of 2 weeks
  • Inhale at the same time every day
NO/$$$$
  • Rinsing mouth after use may help prevent thrush

  • Protect from direct heat and sunlight

  • Discard Arnuity™ Ellipta® inhaler 6 weeks after opening foil tray
  • Corticosteroid - has multiple anti-inflammatory effects; inhibits both inflammatory cells and release of inflammatory mediators
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
All ICS
  • Thrush - up to 34% of patients
  • Voice disorders - up to 50% of patients
  • Reflex cough and bronchospasm

From the Arnuity™ Ellipta® PI
  • Nasopharyngitis - 8%, P - 5%
  • Bronchitis - 7%, P - 6%
  • Headache - 6%, P - 4%
  • Upper respiratory infection - 6%, P - 5%
  • Pharyngitis - 4%, P - 3%
  • Sinusitis - 4%, P - < 1%
  • Oropharyngeal pain - 3%, P - 0%
  • CYP3A4 strong inhibitors - fluticasone is a CYP3A4 substrate. Strong CYP3A4 inhibitors may increase systemic exposure to fluticasone
  • 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
  • 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

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
Fluticasone

(Flovent®)


Advair®

(fluticasone + salmeterol)
Flovent® HFA inhaler
  • Flovent® 44 - 44mcg per actuation
  • Flovent® 110 - 110mcg per actuation
  • Flovent® 220 - 220mcg per actuation
  • HFAs have 120 actuations

Flovent® Diskus - inhalation powder
  • Flovent® Diskus 50 - 50mcg per actuation
  • Flovent® Diskus 100 - 100mcg per actuation
  • Flovent® Diskus 250 - 250mcg per actuation
  • Diskus have 60 actuations
See Asthma dosing chart below NO/$$$-$$$$ 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
  • Corticosteroid - has multiple anti-inflammatory effects; inhibits both inflammatory cells and release of inflammatory mediators
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
All ICS
  • Thrush - up to 34% of patients
  • Voice disorders - up to 50% of patients
  • Reflex cough and bronchospasm

From the Flovent® HFA PI
  • Upper respiratory infection - 16%, P - 14%
  • Throat irritation - 8%, P - 5%
  • Sinusitis - 7%, P - 3%
  • Headache - 7%, P - 6%
  • Upper respiratory infection - 16%, P - 14%
  • CYP3A4 strong inhibitors - fluticasone is a CYP3A4 substrate. Strong CYP3A4 inhibitors may increase systemic exposure to fluticasone
  • 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
  • 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

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
Mometasone

(Asmanex®)


Dulera®

(mometasone + formoterol)
Asmanex Twisthaler® - inhalation powder
  • Asmanex® 110 - 100mcg per actuation
  • Asmanex® 220 - 200mcg per actuation
  • Asmanex® 110 - 30 actuation inhaler
  • Asmanex® 220 - 30, 60, and 120 actuation inhalers
See Asthma dosing chart below NO/$$$$
  • Rinsing mouth after use may help prevent thrush

  • Discard the inhaler 45 days after opening the foil pouch
  • Corticosteroid - has multiple anti-inflammatory effects; inhibits both inflammatory cells and release of inflammatory mediators
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
All ICS
  • Thrush - up to 34% of patients
  • Voice disorders - up to 50% of patients
  • Reflex cough and bronchospasm

From the Asmanex® PI
  • Headache - 17%, P - 20%
  • Allergic rhinitis - 11%, P - 13%
  • Pharyngitis - 8%, P - 7%
  • Upper respiratory infection - 8%, P - 7%
  • Sinusitis - 6%, P - 5%
  • CYP3A4 strong inhibitors - mometasone is a CYP3A4 substrate. Strong CYP3A4 inhibitors may increase systemic exposure to mometasone
  • 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
  • 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





Drug Dosage form Dosage Generic/Price Other Indications
(FDA-approved)
Formoterol + budesonide

(Symbicort®)
Symbicort® 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
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

COPD
  • For patients with COPD, the recommended dose is Symbicort 160/4.5 two inhalations twice daily
NO/$$$$
  • 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
  • Maintenance treatment of Asthma

  • Maintenance treatment of Chronic Obstructive Pulmonary Disease (COPD)

  • NOT for relief of acute bronchospasm


Drug Dosage form Dosage Generic/Price Other Indications
(FDA-approved)
Formoterol + mometasone

(Dulera®)
Dulera® 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
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

NO/$$$$
  • Shake well before use

  • Prime inhaler by releasing 4 test sprays

  • Re-prime if not used for ≥ 5 days
  • Maintenance treatment of Asthma

  • NOT for relief of acute bronchospasm


Drug Dosage form Dosage Generic/Price Other Indications
(FDA-approved)
Salmeterol + fluticasone

(Advair®)
Advair® Diskus (fluticasone/salmeterol)
  • Advair® 100/50 - 100 mcg/50 mcg per inhalation
  • Advair® 250/50 - 250 mcg/50 mcg per inhalation
  • Advair® 500/50 - 500 mcg/50 mcg per inhalation
  • Inhalation powder packaged in diskus with 60 doses

Advair® HFA (fluticasone/salmeterol)
  • Advair HFA® 45/21 - 45 mcg/21 mcg per actuation
  • Advair HFA® 115/21 - 115 mcg/21 mcg per actuation
  • Advair HFA® 230/21 - 230 mcg/21 mcg per actuation
  • Inhaler with 120 actuations per inhaler
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

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

HFA and diskus
NO/$$$$
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
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


Drug Dosage form Dosage Generic/Price Other Indications
(FDA-approved)
Vilanterol + fluticasone

(Breo® Ellipta®)
Breo Ellipta® inhaler
  • Inhaler delivers 100 mcg of fluticasone powder and 25 mcg of vilanterol powder per inhalation
  • Inhaler comes with 30 inhalations
COPD
  • One inhalation once daily

Asthma (≥ 18 years old)
  • One inhalation once daily
NO/$$$$
  • 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.
  • 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





Reference: NHLBI Asthma care quick reference
0 - 4 years of age 5 - 11 years of age ≥ 12 years of age
Medication Low Medium High Low Medium High Low Medium High
Beclomethasone
(Qvar®)
given in 2 divided doses

40 or 80 mcg/actuation
N/A 80 - 160mcg a day > 160 - 320mcg a day > 320mcg a day 80 - 240mcg a day > 240 - 480mcg a day > 480mcg a day
Budesonide
(Pulmicort Flexhaler®)
given in 2 divided doses

90 or 180 mcg/actuation
N/A 180 - 360mcg a day > 360 - 720mcg a day > 720mcg a day 180 - 540mcg a day > 540 - 1080mcg a day > 1080mcg a day
Budesonide
(Pulmicort Respules®)
given once daily or
in 2 divided doses

0.25, 0.5, 1 mg nebs
0.25 - 0.5mg a day
(see notes below)
> 0.5 - 1.0mg a day
(see notes below)
> 1.0mg a day
(see notes below)
0.5mg a day 1.0mg a day 2.0mg a day N/A
Ciclesonide
(Alvesco®)
given in 2 divided doses

80 or 160 mcg/actuation
N/A 80 - 160mcg a day > 160 - 320mcg a day > 320mcg a day 160 - 320mcg a day > 320 - 640mcg a day > 640mcg a day
Flunisolide
(Aerospan®)
given in 2 divided doses

80 mcg/actuation
N/A 160mcg a day 320 - 480mcg a day ≥ 480mcg a day 320mcg a day > 320 - 640mcg a day > 640mcg a day
Fluticasone
(Flovent HFA®)
given in 2 divided doses

44, 110, or 220 mcg/actuation
176 mcg a day
(see notes below)
> 176 - 352mcg a day
(see notes below)
> 352mcg a day
(see notes below)
88 - 176mcg a day > 176 - 352mcg a day ≥ 352mcg a day 88 - 264mcg a day > 264 - 440mcg a day > 440mcg a day
Fluticasone
(Flovent Diskus®)
given in 2 divided doses

50, 100, or 250 mcg/actuation
N/A 100 - 200mcg a day > 200 - 400mcg a day > 400mcg a day 100 - 300mcg a day > 300 - 500mcg a day > 500mcg a day
Mometasone
(Asmanex®)
given once daily or
in 2 divided doses

110 or 220 mcg/actuation
N/A 110mcg a day 220 - 440mcg a day > 440mcg a day 110 - 220mcg a day > 220 - 440mcg a day > 440mcg a day
  • Some doses may be outside package labeling, especially in the high-dose range
  • Budesonide nebulizer suspension is the only inhaled corticosteroid (ICS) with FDA-approved labeling for children < 4 years of age.
  • For children < 4 years of age:
    • The safety and efficacy of ICS in children < 1 year of age has not been established
    • Children < 4 years of age generally require delivery of ICS (budesonide and fluticasone MDI) through a face mask that fits snugly over nose and mouth to avoid nebulizing in the eyes. Face should be washed after treatment to prevent local corticosteroid side effects.
    • For budesonide, the dose may be given 1–3 times daily
    • Budesonide suspension is compatible with albuterol, ipratropium, and levalbuterol nebulizer solutions in the same nebulizer. Use only jet nebulizers, as ultrasonic nebulizers are ineffective for suspensions.
    • For fluticasone MDI, the dose should be divided 2 times daily; the low dose for children < 4 years of age is higher than for children 5–11 years of age because of lower dose delivered with face mask and data on efficacy in young children.




Study Criteria Intervention Primary outcome Results
Advair®
vs
Doubling Flovent®



Am J Respir Crit Care Med
2010


PubMed abstract


Inclusion criteria:
  • Children aged 6 - 16 years with asthma
  • Symptomatic on conventional doses of ICS (up to 250 mcg fluticasone or equivalent)

  • All participants were enrolled in a 4 week run-in period where they were given fluticasone 100 mcg twice a day
  • Patients who were still symptomatic during the last 14 days of the run-in phase were randomized to treatment
Group 1 (80 patients) - Fluticasone 200 mcg twice a day for 26 weeks

Group 2 (78 patients) - Salmeterol/fluticasone (Advair®) 50/100 twice a day for 26 weeks

  • Albuterol was allowed during the study
  • Primary outcome parameter was the percentage of symptom-free days during the last 10 weeks of the treatment period.
  • After the run-in period, percentage of symptom-free days was about 32% in both groups
  • Percentage of symptom-free days during the last 10 weeks of the treatment period were ∼ 50% in both groups
  • There was no significant difference between the two groups (p-value=0.93)
  • FEV₁ measurements did not differ significantly between the two groups at the end of the study (p-value 0.39)

Study Criteria Intervention Primary outcome Results
Flovent®
vs
Advair®
vs
Flovent® + Singulair®

CARE study



NEJM
2010


PubMed abstract


Inclusion criteria:
  • Children aged 6 - 17 years with mild-moderate asthma
  • An FEV₁ of at least 60% before bronchodilation, and an increase in the FEV₁ of at least 12% (bronchodilator reversibility)

  • All participants were enrolled in a 2 - 8 week run-in period where they were given fluticasone 100 mcg twice a day
  • Patients who were still symptomatic during a 2 week period of the run-in phase were randomized to treatment
There were 3 treatment regimens and all patients received each regimen for 16 weeks in random order. A total of 165 patients were evaluated.

  • Treatment 1 - Fluticasone diskus 250 mcg twice daily for 16 weeks
  • Treatment 2 - Salmeterol 50 mcg/fluticasone 100 mcg (Advair diskus®) twice daily for 16 weeks
  • Treatment 3 - Fluticasone 100 mcg twice daily + 5 - 10 mg of montelukast (Singulair®) for 16 weeks

  • Albuterol and prednisone were allowed as needed
  • 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.
  • Treatment 2 was more likely to be the best response when compared to Treatment 1 (p-value=0.002) and Treatment 3 (p-value=0.004)
  • There was no significant difference between Treatment 1 and Treatment 3
  • White race predicted a better response to Advair® (Treatment 2)
  • Black patients were least likely to have a best response to Singulair® (Treatment 3)




Study Criteria Intervention Primary outcome Results
Advair®
vs
Serevent®
vs
Flovent®
vs
Placebo

TORCH study



NEJM
2007


PubMed abstract


Inclusion criteria:
  • Current or former smokers with at least a 10-pack-year history
  • PFTs consistent with at least moderate COPD (FEV₁ < 60% of predicted)

Exclusion criteria:
  • Long-term oral corticosteroids
  • Oxygen therapy
Patients were randomized to 1 of 4 treatments:
  • Group 1 (1533 patients) - Advair (fluticasone + salmeterol) 500/50 twice daily
  • Group 2 (1521 patients) - Salmeterol 50 mcg twice daily
  • Group 3 (1534 patients) - Fluticasone 500 mcg twice daily
  • Group 4 (1524 patients) - Placebo twice daily

  • Long-acting beta agonists and inhaled corticosteroids were discontinued in all patients before the study began
  • Other COPD meds were allowed during the study
  • The primary outcome was death from any cause over three years of follow-up
Probability of death:
  • Group 1 - 12.6%
  • Group 2 - 13.5%
  • Group 3 - 16%
  • Group 4 - 15.2%
Comparisons (Group # vs Group #, p-value):
  • 1 vs 2, p=0.48 : 1 vs 3, p=0.007 : 1 vs 4, p=0.052
  • 2 vs 1, p=0.48 : 2 vs 4, p=0.18
  • 3 vs 1, p=0.007 : 3 vs 4, p=0.53

  • Patients on fluticasone were significantly more likely to develop pneumonia (Group 1 - 19.6%, Group 3 - 18.3%) than patients not on fluticasone (Group 2 - 13.3%, Group 4 - 12.3%)



  • ICS use and linear growth in children

    • Long-term use in childhood of ICS may cause a stunting of linear growth
    • A study published in the NEJM in 2012 looked at the effect of ICS on height. The study involved a group of asthmatics who had been randomized to budesonide, nedocromil, or placebo in childhood. The active part of the trial lasted an average of 4.3 years. The participants were then followed into adulthood and their adult heights were compared.

      • The study found the following:
        • The average adult height was 1.2 cm lower in the budesonide group (95% CI -1.9 to -0.5)
        • The decrease in growth-velocity was primarily seen in the first 2 years of treatment
        • The effect was largely seen in prepubertal participants
        • In general, participants with a longer duration of asthma had shorter adult heights
        • The trial used a budesonide dose of 400mcg/day [3]

    • Conclusions:
      • Use of ICS in prepubertal children may cause a small decrease in adult height (1.2cm on average)
      • The benefits of good asthma control provided by ICS will likely outweigh this small downside in most patients



  • 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 12/2014]
    • Pricing may vary by region and availability



  • REFERENCES

    • References:
    • 1 - NHLBI 2007 guidelines
    • 2 - Manufacturer's package insert
    • 3 - PMID 22938716