Head-to-head clinical analysis & difference comparison: details on mechanism of action, dosing, half-life, interactions, and maternal-fetal safety.
BREO ELLIPTA vs ACLOVATE
Clinician-reviewed, head-to-head comparison of mechanism, dosing, pharmacokinetics, and safety profiles.
Last clinically reviewed: July 2026 · OpiCalc Medical Review Team
Combination of fluticasone furoate, a corticosteroid that binds to glucocorticoid receptors to inhibit inflammatory gene transcription, and vilanterol, a long-acting beta2-adrenergic agonist that activates adenylate cyclase leading to bronchodilation.
Aclovate (alclometasone dipropionate) is a synthetic corticosteroid with anti-inflammatory, antipruritic, and vasoconstrictive properties. Its mechanism involves binding to glucocorticoid receptors, modulating gene expression to inhibit phospholipase A2, reducing arachidonic acid release, and decreasing prostaglandin and leukotriene synthesis.
Maintenance treatment of chronic obstructive pulmonary disease (COPD) including chronic bronchitis and/or emphysema,Maintenance treatment of asthma in patients aged 18 years and older
Relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses (e.g., atopic dermatitis, contact dermatitis, eczema, psoriasis) - FDA approved,Off-label: Treatment of mild to moderate plaque psoriasis, seborrheic dermatitis, and lichen planus
One inhalation (100 mcg fluticasone furoate / 25 mcg vilanterol) once daily via oral inhalation.
Apply a thin film to affected skin areas twice daily. Not for ophthalmic, oral, or intravaginal use.
Fluticasone furoate: 24 hours (supports once-daily dosing). Vilanterol: 11 hours (supports once-daily dosing).
Terminal elimination half-life: approximately 6-8 hours after topical application; systemic absorption is minimal under normal use.
Fluticasone furoate: primarily metabolized by CYP3A4; Vilanterol: primarily metabolized by CYP3A4.
Aclovate is metabolized in the skin and liver via ester hydrolysis to inactive metabolites. Systemic metabolism primarily involves cytochrome P450 enzymes (CYP3A4) for any absorbed fraction, but extensive first-pass metabolism limits systemic exposure.
Fluticasone furoate is eliminated primarily via fecal excretion (approximately 101% of an oral dose) due to biliary clearance, with minimal renal excretion (<1%). Vilanterol is eliminated via metabolism and subsequent renal (approximately 70% of an IV dose) and fecal (approximately 30% of an IV dose) excretion.
Renal (primarily as metabolites, <5% unchanged), biliary/fecal (minor).
Fluticasone furoate: >99.8% (primarily albumin). Vilanterol: approximately 94% (albumin and alpha-1-acid glycoprotein).
Approximately 90%, primarily to albumin and corticosteroid-binding globulin (CBG).
Fluticasone furoate: approximately 4.5 L/kg (extensive tissue distribution). Vilanterol: approximately 165 L (large Vd, extensive distribution).
Not well-characterized in topical use; after systemic absorption, Vd is approximately 1-2 L/kg, indicating distribution into tissues.
Inhaled: Fluticasone furoate absolute bioavailability approximately 15% (lung deposition). Vilanterol absolute bioavailability approximately 27% (lung deposition). Oral bioavailability is negligible for both (<2% for fluticasone furoate, <5% for vilanterol).
Topical: approximately 1-3% systemic absorption on intact skin; increased up to 15% on occluded or damaged skin.
No dosage adjustment required for renal impairment. However, use with caution in severe renal impairment due to potential for increased systemic exposure.
No dose adjustment required. Topical use with minimal systemic absorption.
Child-Pugh Class A and B: No dosage adjustment recommended. Child-Pugh Class C: Contraindicated.
No dose adjustment required. Topical use with minimal systemic absorption.
Indicated for children aged 5 years and older with asthma. For ages 5-11: one inhalation of 100 mcg/25 mcg once daily. For ages 12 and older: same as adult dosing.
Use smallest amount effective for shortest duration. Avoid prolonged use, occlusive dressings, or application to large surface areas. Safety in children <1 year not established.
No dose adjustment required for elderly patients. Use with caution due to increased risk of comorbidities and adverse effects.
Use with caution due to increased risk of skin atrophy and systemic absorption. Limit frequency and duration; avoid occlusive dressings.
Long-acting beta2-adrenergic agonists (LABAs) increase the risk of asthma-related death. Use only as additional therapy for patients not adequately controlled on a long-term asthma control medication or whose disease severity warrants initiation of both an inhaled corticosteroid and a LABA.
No FDA black box warning.
Increased risk of asthma-related death when used as monotherapy for asthma without inhaled corticosteroid,Candida infections of the mouth and pharynx,Pneumonia in patients with COPD,Adrenal insufficiency,Hypercorticism and adrenal suppression,Paradoxical bronchospasm,Hypersensitivity reactions including anaphylaxis,Cardiovascular effects like increased blood pressure and heart rate,Eosinophilic conditions,Reduced bone mineral density,Glaucoma and cataracts
Topical corticosteroids can cause hypothalamic-pituitary-adrenal (HPA) axis suppression, especially with prolonged use, large surface area, occlusion, or in pediatric patients.,Reversible HPA axis suppression may occur after discontinuation.,Systemic effects including Cushing's syndrome, hyperglycemia, and glucosuria have been reported.,Local adverse reactions: burning, itching, irritation, dryness, folliculitis, hypopigmentation, allergic contact dermatitis, maceration, secondary infection, skin atrophy, striae, and miliaria.,Use caution in patients with impaired skin integrity or areas of skin atrophy.,Pediatric patients may be more susceptible to systemic toxicity due to higher skin surface-to-body-weight ratio.
Status asthmaticus or acute episodes of COPD requiring intensive therapy,Primary treatment of acute asthma exacerbation,Severe hypersensitivity to milk proteins or any ingredient
Hypersensitivity to alclometasone dipropionate or any component of the formulation.,Untreated bacterial, fungal, or viral skin infections (e.g., herpes simplex, varicella, tuberculosis of the skin).
No specific food interactions reported. However, grapefruit juice may increase systemic exposure to fluticasone furoate via CYP3A4 inhibition; although clinical significance is low, avoid excessive grapefruit consumption. No dietary restrictions necessary.
No known food interactions with topical Aclovate.
Insufficient human data; based on animal studies, corticosteroids (fluticasone furoate) and LABA (vilanterol) show no major teratogenicity but may cause fetal growth restriction at high systemic exposures. Avoid in first trimester unless benefit outweighs risk; use lowest effective dose in later trimesters.
Topical corticosteroids like ACLOVATE (alclometasone dipropionate) are generally considered low risk in pregnancy, but systemic absorption can occur. Class C: Fetal risk cannot be ruled out. Avoid extensive use or prolonged treatment, especially in first trimester. Second and third trimester: Use only if clearly needed, minimal area and duration.
No data on drug excretion in human milk; M/P ratio unknown. Corticosteroids and LABAs are expected to be present in low concentrations. Caution if breastfeeding, especially in preterm infants. Consider alternative therapies.
Safety unknown; likely minimal systemic absorption due to low potency. M/P ratio not established. Avoid application to breasts or large areas; use caution.
No specific dose adjustments required due to pregnancy-induced pharmacokinetic changes, but use lowest effective dose to maintain asthma control due to potential fetal risk.
No standard dose adjustment required; however, limit potency, frequency, and duration to lowest effective due to altered skin permeability. No pharmacokinetic changes necessitate dose change.
Breo Ellipta (fluticasone furoate/vilanterol) is an ICS/LABA combination indicated for maintenance treatment of COPD and asthma. It is not for acute bronchospasm. The ELLIPTA inhaler is a once-daily, dry powder inhaler; each actuation delivers a fixed dose. Rinse mouth with water after use without swallowing to reduce oral candidiasis. Monitor for pneumonia in COPD patients. In asthma, it is not indicated for patients under 18 years; for COPD, use only in patients with a history of exacerbations. Do not discontinue abruptly.
Topical corticosteroids like Aclovate are classified as low-potency (Group VI). They are suitable for thin skin areas (e.g., face, flexures) and for children. Avoid prolonged use without interruption to minimize systemic absorption, especially in pediatric patients due to higher skin surface area-to-body weight ratio.
Use exactly as prescribed; it is not a rescue inhaler for sudden breathing problems.,Rinse mouth with water after each dose without swallowing to prevent oral thrush.,Do not stop taking this medication without consulting your doctor; stopping can worsen breathing.,Tell your doctor if you have any signs of infection, pneumonia, or worsening breathing.,Store the inhaler at room temperature away from moisture and heat; keep it closed when not in use.
Apply a thin layer to affected skin only, not to normal surrounding skin.,Do not cover with bandages or dressings unless directed by your doctor.,Use for the prescribed duration; do not use longer than 2 weeks at a time.,Avoid contact with eyes, mouth, and open wounds.,Report any signs of skin thinning, redness, or irritation to your healthcare provider.
No interactions on record
No interactions on record
Explore head-to-head clinical comparisons of other medications in the same therapeutic classes.
Common clinical questions about BREO ELLIPTA vs ACLOVATE, answered by our medical review team.
BREO ELLIPTA is a Corticosteroid/Beta-2 Agonist Combination that works by Combination of fluticasone furoate, a corticosteroid that binds to glucocorticoid receptors to inhibit inflammatory gene transcription, and vilanterol, a long-acting beta2-adrenergic agonist that activates adenylate cyclase leading to bronchodilation.. ACLOVATE is a Topical Corticosteroid that works by Aclovate (alclometasone dipropionate) is a synthetic corticosteroid with anti-inflammatory, antipruritic, and vasoconstrictive properties. Its mechanism involves binding to glucocorticoid receptors, modulating gene expression to inhibit phospholipase A2, reducing arachidonic acid release, and decreasing prostaglandin and leukotriene synthesis.. They differ in pharmacokinetic profiles, FDA-approved indications, and side effect profiles.
Potency comparisons between BREO ELLIPTA and ACLOVATE depend on the specific clinical indication. These are agents from distinct pharmacological classes and are not directly interchangeable by dose. A physician or clinical pharmacist should guide any therapeutic switching decisions.
The standard adult dose of BREO ELLIPTA is: One inhalation (100 mcg fluticasone furoate / 25 mcg vilanterol) once daily via oral inhalation.. The standard adult dose of ACLOVATE is: Apply a thin film to affected skin areas twice daily. Not for ophthalmic, oral, or intravaginal use.. Dosing should always be individualized based on indication, renal and hepatic function, age, and other patient factors.
No direct drug-drug interaction has been formally documented between BREO ELLIPTA and ACLOVATE in current clinical databases. However, individual patient risk factors including other medications, organ function, and comorbidities should always be evaluated by a qualified healthcare provider.
The maternal-fetal safety profiles differ. BREO ELLIPTA is classified as Category C. Insufficient human data; based on animal studies, corticosteroids (fluticasone furoate) and LABA (vilanterol) show no major teratogenicity but may cause fetal growth restriction at. ACLOVATE is classified as Category C. Topical corticosteroids like ACLOVATE (alclometasone dipropionate) are generally considered low risk in pregnancy, but systemic absorption can occur. Class C: Fetal risk cannot be . Always consult a maternal-fetal medicine specialist before taking either drug during pregnancy or lactation.