Prescribing information

 

       

Indication: ENERZAIR BREEZHALER is indicated as a 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.1

ENERZAIR® BREEZHALER® (IND/GLY/MF) high-dose improves patients’ ability to breathe vs. IND/MF high-dose

In symptomatic asthma patients ≥18 years of age, despite treatment with high-dose LABA/ICS1,2

The doses reported within the clinical trials were contained dose rather than the delivered dose

 

Lung function with ENERZAIR® BREEZHALER® (IND/GLY/MF) high-dose, IND/MF medium and high-doses and SAL/FLU high-dose in secondary analyses

In symptomatic asthma patients ≥18 years of age, despite treatment with high-dose LABA/ICS1,2

None of these secondary analyses were controlled for multiplicity;2 inferences based on these data cannot be made due to lack of power

Asthma control and severe exacerbations with ENERZAIR® BREEZHALER® (IND/GLY/MF) high-dose, IND/MF high-dose and SAL/FLU high-dose in secondary analyses

In symptomatic asthma patients ≥18 years of age, despite treatment with high-dose LABA/ICS1,2

None of these secondary analyses were controlled for multiplicity;2 inferences based on these data cannot be made due to lack of power

*ACQ-7 responder = patient achieving a minimal clinically important difference (MCID) of ≥0.5-point improvement from baseline in ACQ-7 score.2
**A severe exacerbation was defined as an aggravation of asthma symptoms (such as shortness of breath, cough, wheezing, or chest tightness) that requires systemic corticosteroids for at least 3 consecutive days or a need for an emergency room visit, hospitalisation owing to asthma, or death due to asthma.2

ENERZAIR® BREEZHALER® (IND/GLY/MF) high-dose is non-inferior vs. SAL/FLU high-dose + TIO with regards to asthma-related quality of life

 

In symptomatic asthma patients ≥18 years of age, despite treatment with high-dose LABA/ICS1,4

 

These secondary analyses were not controlled for multiplicity;4 inferences based on these data cannot be made due to lack of power

 

*AQLQ responder = patient achieving a minimal clinically important difference (MCID) of ≥0.5-point improvement from baseline in AQLQ score.4

ARGON trial: 24-week randomised study in 1,426 asthma patients, inadequately controlled on LABA/ICS.4 Data relating to ENERZAIR® BREEZHALER® medium-dose have been excluded as this dosing regimen is not licensed for use in the UK.

Full information on these endpoints can be obtained from Novartis Medical Information. ENERZAIR® BREEZHALER® high-dose = IND/GLY/MF 150/50/160μg (once-daily); SAL/FLU high-dose = SAL/FLU 50/500μg (twice-daily); TIO = TIO 5μg (once-daily).

AQLQ, Asthma Quality of Life Questionnaire; CI, confidence interval; FEV1, forced expiratory volume in 1 second; GLY, glycopyrronium; ICS, inhaled corticosteroid; IND, indacaterol acetate; LABA, long-acting beta2-agonist; LS, least squares; MF, mometasone furoate; SAL/FLU, salmeterol/fluticasone propionate; TIO, tiotropium.

ENERZAIR BREEZHALER (indacaterol acetate/mometasone furoate inhalation powder) was generally well tolerated2,4

The ENERZAIR BREEZHALER device was well tolerated: AEs and SAEs were balanced and safety was comparable across treatment arms.2,4

 

Indication: ENERZAIR BREEZHALER is indicated as a 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.1

References

  1. ENERZAIR BREEZHALER Summary of Product Characteristics.
  2. Kerstjens H et al. Lancet Respir Med 2020;8(10):1000-1012.
  3. Kerstjens H et al. Lancet Respir Med 2020;8(10):1000-1012 (Supplementary appendix).
  4. Gessner C et al. Respir Med 2020;170:106021.
  5. Kornmann O et al. Respir Med 2020;161:105809 [Epub ahead of print].
  6. Van Zyl-Smit R et al. Lancet Respir Med 2020;8(10):987-999.
ENE20-C004 November 2020.
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Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Novartis via [email protected] or online through the pharmacovigilance intake (PVI) tool at www.report.novartis.com
If you have a question about the product, please contact Medical Information on 01276 698370 or by email at [email protected]