1. Efficacy and Safety

Efficacy and Safety

ENERZAIR® BREEZHALER® provides substantial reduction of asthma attacks*

In a secondary analysis,** ENERZAIR® BREEZHALER® high-dose (once-daily) reduced exacerbations vs. SAL/FLU high-dose (twice-daily)

 

Primary endpoint was met:

ENERZAIR® BREEZHALER® significantly improved trough FEV1 by +76mL (95% CI: 41,111) and +65mL (95% CI: 31, 99) at Week 26 vs. IND/MF for medium - and high-doses respectively, p<0.001.1

Key secondary endpoint, improvement in ACQ-7 score for ENERZAIR® BREEZHALER® vs. IND/MF at Week 26, was not met; however all five arms demonstrated similarly high and clinically relevant improvement from baseline.1

ENERZAIR® BREEZHALER® improves patients’ ability to breathe*

In a secondary analysis,** ENERZAIR® BREEZHALER® high-dose (once-daily) improved lung function vs. SAL/FLU high-dose (twice-daily)1

 

Primary endpoint:

Improvement in lung function with ENERZAIR® BREEZHALER® high- and medium-doses vs. IND/MF high- and medium-doses was met1

ENERZAIR® BREEZHALER® improves asthma control*

A secondary analysis** demonstrated a higher proportion of ACQ-7 responderswith ENERZAIR® BREEZHALER® high-dose (once-daily) vs. SAL/FLU high-dose (twice-daily)1

Clinically meaningful improvement of asthma control

Statistically significant improvements in the proportion of ACQ-7 responders at Weeks 4, 12 and 52 vs. SAL/FLU high-dose (twice-daily) (p≤0.019). Improvement was not statistically significant at Week 26 (p=0.151)1

Key secondary endpoint at Week 26 not met:

No significant difference in the change in ACQ-7 score from baseline at Week 26 with ENERZAIR® BREEZHALER® medium- and high-dose vs. corresponding doses of IND/MF (p=0.085 and p=0.729, respectively)1

 

 

IRIDIUM

Improvements in asthma control (ACQ-7) already at Week 4
Improved response to therapy at Week 52 vs. SAL/FLU high-dose (twice-daily)

 

The ENERZAIR® BREEZHALER® family has a favorable safety and tolerability profile1,3-5

Both ENERZAIR® BREEZHALER® and ATECTURA® BREEZHALER® were well-tolerated: AEs and SAEs were balanced & safety was comparable across treatment arms

 

To learn more about the Quartz, palladium, iridium and Argon studies, click here.

 

ACQ-7, asthma control questionnaire-7; AE, adverse events; CI, confidence interval; FEV1, forced expiratory volume in 1 second; GLY, glycopyrronium; ICS, inhaled corticosteroid; IND, indacaterol acetate; LABA, long-acting beta2-agonist; MF, mometasone furoate; RR, rate ratio; SAE, serious adverse events; SAL/FLU, salmeterol/fluticasone propionate.

 

*In symptomatic asthma patients, despite treatment with medium- or high-dose LABA/ICS.1
**Secondary analysis, not controlled for multiplicity – analyzed using a generalized linear model assuming the negative binomial distribution.1
†Trough FEV1, defined as the highest bronchodilator effect on FEV1 approximately 24 hours after the last dose of each treatment period.1
‡As measured by FEV1 five minutes post-dose on Day 1.1
ACQ-7 responder = patient achieving a minimal clinically important different of ≥0.5-point improvement from baseline in ACQ-7 score.1

 

REFERENCES:

  1. Kerstjens H et al. Once-daily, single-inhaler indacaterol/glycopyrronium/mometasone versus indacaterol/mometasone or twice-daily salmeterol/fluticasone in patients with inadequately controlled asthma (IRIDIUM): a randomised, double-blind, controlled Phase III study. Lancet Resp Med; https://doi.org/10.1016/S2213-2600(20)30190-9.
  2. IRIDIUM trial supplementary appendix, data on file.
  3. Van Zyl-Smit R. et al. Once-daily mometasone/indacaterol versus mometasone or twice-daily fluticasone/salmeterol in patients with inadequately controlled asthma (PALLADIUM): a randomised, double-blind, triple-dummy, controlled Phase III study. Lancet Resp Med; https://doi.org/10.1016/S2213-2600(20)30178-8.
  4. Kornmann O, et al. Respiratory Medicine. 2020;161:105809 [Epub ahead of print].
  5. Gessner C et al. Fixed-dose combination of indacaterol/glycopyrronium/mometasone furoate once-daily versus salmeterol/fluticasone twice-daily plus tiotropium once-daily in patients with uncontrolled asthma: A randomised, Phase IIIb, non-inferiority study (ARGON). Resp Med 2020;106021. DOI: https://doi.org/10.1016/j.rmed.2020.106021.
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Abbreviated Prescribing Information

Please refer to Summary of Product Characteristics (SmPC) before prescribing. 

Enerzair® Breezhaler® (indacaterol (as acetate), glycopyrronium bromide, mometasone furoate) inhalation powder, hard capsules. 

Presentation: Hard capsules for inhalation each containing 150 mcg of indacaterol (as acetate), 63 mcg of glycopyrronium bromide equivalent to 50 mcg of glycopyrronium and 160 mcg of mometasone furoate. Each delivered dose contains 114 mcg of indacaterol acetate, 46 mcg of glycopyrronium and 136 mcg of mometasone furoate. Indications: Maintenance treatment of asthma in adult patients not adequately controlled with a maintenance combination of a long-acting beta2-agonist and a high dose of an inhaled corticosteroid who experienced one or more asthma exacerbations in the previous year. Dosage and Administration: One capsule once daily, administered at the same time of the day each day, using the Enerzair Breezhaler inhaler. No dose adjustment is required in elderly patients, in patients with mild to moderate renal impairment, or in patients with mild or moderate hepatic impairment. Caution should be observed in patients with severe renal impairment or end-stage renal disease requiring dialysis. No data available for patients with severe hepatic impairment, only use in these patients if the expected benefit outweighs the potential risk. The safety and efficacy in paediatric patients below 18 years of age have not been established. Contraindications: Hypersensitivity to the active substances, lactose monohydrate or magnesium stearate. Warnings/Precautions: Deterioration of disease: Should not be used to treat acute asthma symptoms, including acute episodes of bronchospasm. Treatment should not be stopped abruptly. Hypersensitivity: Immediate hypersensitivity reactions have been observed after administration. If signs suggesting allergic reactions occur, in particular angioedema, urticaria or skin rash, treatment should be discontinued immediately and alternative therapy instituted. Paradoxical bronchospasm: If paradoxical bronchospasm occurs, treatment should be discontinued immediately and alternative therapy instituted. Cardiovascular effects: Like other medicinal products containing beta2-adrenergic agonists, may produce a clinically significant cardiovascular effect in some patients as measured by increases in pulse rate, blood pressure, and/or symptoms. Use with caution in patients with cardiovascular disorders (coronary artery disease, acute myocardial infarction, cardiac arrhythmias, hypertension), convulsive disorders, thyrotoxicosis, and in patients who are unusually responsive to beta2-adrenergic agonists. Long acting beta2-adrenergic agonists (LABA) or LABA containing combination products such as Enerzair Breezhaler should be used with caution in patients with known or suspected prolongation of the QT interval or who are being treated with medicinal products affecting the QT interval. Hypokalaemia: Beta2-adrenergic agonists may produce significant hypokalaemia in some patients, which has the potential to produce adverse cardiovascular effects. The decrease in serum potassium is usually transient, not requiring supplementation. In patients with severe asthma hypokalaemia may be potentiated by hypoxia and concomitant treatment, which may increase the susceptibility to cardiac arrhythmias. Hyperglycaemia: Inhalation of high dose of beta2-adrenergic agonists and corticosteroids may produce increases in plasma glucose. Upon initiation of treatment, plasma glucose should be monitored more closely in diabetic patients. Anticholinergic effect related to glycopyrronium: use with caution in patients with narrow-angle glaucoma or urinary retention. Prevention of oropharyngeal infections: In order to reduce the risk of oropharyngeal candida infection, patients should be advised to rinse their mouth or gargle with water without swallowing it or brush their teeth after inhaling the prescribed dose. Systemic effects of corticosteroids: Systemic effects of inhaled corticosteroids may occur, particularly at high doses prescribed for prolonged periods. Should be administered with caution in patients with pulmonary tuberculosis or in patients with chronic or untreated infections. Excipients: Contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose galactose malabsorption should not take this medicinal product. Interactions: No specific interaction studies were conducted with indacaterol/glycopyrronium/mometasone furoate. Information on the potential for interactions is based on the potential for each of the monotherapy components. Medicinal products that prolong QTc interval: Should be administered with caution in patients being treated with monoamine oxidase inhibitors, tricyclic antidepressants, or medicinal products known to prolong the QT-interval. Hypokalaemic treatment: Concomitant treatment with methylxanthine derivatives, steroids, or non-potassium sparing diuretics may potentiate the possible hypokalaemic effect of beta2-adrenergic agonists. Beta-adrenergic blockers: Should not be given together with beta-adrenergic blockers unless there are compelling reasons for their use.  Where required, cardioselective beta-adrenergic blockers should be preferred, although they should be administered with caution. CYP3A4 and P-glycoprotein inhibitors: Inhibition of CYP3A4 and P-gp has no impact on the safety of therapeutic doses of Enerzair Breezhaler. Cimetidine and inhibitors of organic cation transport: No clinically relevant drug interaction is expected when glycopyrronium is co-administered with cimetidine or other inhibitors of the organic cation transport. Other long-acting antimuscarinics and LABAs: Co-administration with other medicinal products containing long-acting antimuscarinics or LABAs is not recommended. Fertility, Pregnancy and Lactation: Should only be used during pregnancy if the expected benefit to the patient justifies the potential risk to the foetus. No information available on the presence of indacaterol, glycopyrronium or mometasone furoate in human milk, on the effects on a breast-fed infant, or on the effects on milk production. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from therapy, taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman. Studies do not indicate a concern regarding fertility in either males or females. Undesirable Effects: Very common (≥1/10): nasopharyngitis, asthma (exacerbation). Common (≥1/100 to <1/10): upper respiratory tract infection, candidiasis, urinary tract infection, hypersensitivity, headache, tachycardia, oropharyngeal pain, cough, dysphonia, gastroenteritis, musculoskeletal pain, muscle spasms, pyrexia. Uncommon (≥1/1,000 to <1/100): hyperglycaemia, cataract, dry mouth, rash, pruritus, dysuria. Please consult the Summary of Product Characteristics for a detailed listing of all adverse events before prescribing. Pack Size(s):  Single pack containing 30 x 1 hard capsules, together with one inhaler. Pack containing 30 x 1 hard capsules, together with 1 inhaler and 1 sensor. The sensor and App are not required for administration to the patient. The sensor and App do not control or interfere with delivery of the medicinal product using the inhaler. Legal Category: POM. Product (Marketing) Authorisation Number(s): EU/1/20/1438/002 & 003. Product (Marketing) Authorisation Holder: Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland. Full prescribing information is available upon request from: Novartis Ireland Limited, Vista Building, Elm Park Business Park, Elm Park, Dublin 4. Tel: 01-2601255 or at www.medicines.ie. Detailed information on this product is also available on the website of the European Medicines Agency http://www.ema.europa.eu
Prescribing Information last revised: July 2020