Prescribing information

 

   

ATECTURA® BREEZHALER® low-dose significantly improved lung function and asthma control after 12 weeks of treatment (QUARTZ study)
 

ATECTURA low-dose = IND/MF 150/80μg (once-daily); MF low-dose = MF 200μg (once-daily).

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

 

QUARTZ study: main results
 

 

QUARTZ STUDY DETAILS

A 12-week treatment, randomised, double-blind, double-dummy, parallel-group study in 802 asthma patients aged ≥12 and ≤75 years with a documented diagnosis of asthma for a period of ≥3 months prior to screening, who were taking low-dose ICS (with or without controller, e.g. LABA) for at least 1 month prior to screening visit.
Primary endpoint was met: ATECTURA BREEZHALER low-dose significantly improved trough FEV1 compared to MF low-dose after 12 weeks of treatment – mean difference 182mL (95% CI: 148, 217; p<0.001).
Key secondary endpoint, superiority in ACQ-7 score (low-dose ATECTURA BREEZHALER vs low-dose MF) after 12 weeks, was met with ATECTURA BREEZHALER low-dose demonstrating statistically significant improvements in asthma control compared with MF low-dose, as measured by ACQ-7 after 12 weeks of treatment – mean treatment difference: -0.218 (95% CI: -0.293, -0.143; p<0.001).

ACQ-7, Asthma Control Questionnaire-7; CI, confidence interval; FEV1, forced expiratory volume in 1 second; ICS, inhaled corticosteroid; LABA, long-acting beta2-agonist; MF, mometasone furoate.5

 

Response rate with ATECTURA low-dose and MF low-dose in secondary endpoint

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

ATECTURA® BREEZHALER® (indacaterol acetate/mometasone furoate inhalation powder) medium-dose and high-dose improve ability to breathe and asthma control vs MF (PALLADIUM study)
 

 

PALLADIUM study: main results

 

 

FEV1 improvements, exacerbation reduction and rescue medication-free days with ATECTURA medium-dose and MF medium-dose in secondary endpoints

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

 

 

PALLADIUM STUDY DETAILS

A 52-week randomised study in 2,216 asthma patients ≥12 years and ≤75 years, inadequately controlled on medium- or high-dose ICS and/or low-dose LABA/ICS.
Primary endpoint was met: ATECTURA BREEZHALER significantly improved trough FEV1 by +211 mL (95% CI: 167, 255) and +132 mL (95% CI: 88, 176) for medium- and high-doses respectively at Week 26 vs MF, p<0.001.
Key secondary endpoint, superiority in ACQ-7 score (combined doses of ATECTURA BREEZHALER vs MF) at Week 26, was met with ATECTURA BREEZHALER combined doses significantly improving ACQ-7 vs MF combined doses (treatment difference was -0.209 [95% CI: -0.270, -0.149]; p<0.001). Refer to ClinicalTrials.gov (NCT02554786) for more information about other secondary analyses. ATECTURA BREEZHALER high-dose = IND/MF 150/320 μg (once-daily); SAL/FLU high-dose = SAL/FLU 50/500 μg (twice-daily).

ACQ-7, Asthma Control Questionnaire-7; CI, confidence interval; FEV1, forced expiratory volume in 1 second; ICS, inhaled corticosteroid; IND, indacaterol acetate; LABA, long-acting beta2-agonist; MF, mometasone furoate; MMRM, mixed model for repeated measures; SAL/FLU, salmeterol/fluticasone propionate; SABA, short-acting beta2-agonist.2

 

FEV1 improvements, exacerbation reduction and rescue medication-free days with ATECTURA high-dose and SAL/FLU high-dose in secondary endpoints

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

 

 

Rescue medication5

There was a treatment difference in mean daily number of puffs of rescue medication of -0.26 between high-dose IND/MF and high-dose SAL/FL (smaller in IND/MF group; 95% CI: -0.37,-0.14). There was a treatment difference in rescue medication-free days of 8.1% between high-dose IND/MF and high-dose SAL/FLU (greater in IND/MF group; 95% CI: 4.3,11.8).
 

Exacerbations5

There was a treatment difference in number of patients suffering all exacerbations of 70% between high-dose IND/MF and high-dose SAL/FLU (smaller in IND/MF group; rate ratio 0.30 [95% CI: 0.18, 0.50]; p<0.001).

 

ATECTURA BREEZHALER was generally well tolerated.2,5

Full details on contraindications, special warnings and precautions for use are available in the Summary of Product Characteristics.

 

ATECTURA BREEZHALER was generally well-tolerated:

  • AEs and SAEs were comparable across treatment arms
  • Contraindications: Hypersensitivity to any of the active substances or excipients

PALLADIUM/QUARTZ2,5

  • Very common AEs during the trial included asthma exacerbation and nasopharyngitis
  • Common AEs included upper respiratory tract infection, hypersensitivity, headache, oropharyngeal pain, dysphonia and musculoskeletal pain
  • Angioedema was not observed during the study but is a potential AE of ATECTURA BREEZHALER
  • SAEs included asthma exacerbation, acute myocardial infarction, pneumonia, peritonitis and rib fracture

 

*Analysed using a MMRM on the full analysis set (randomised patients receiving at least one dose of the study drug).
A severe exacerbation is defined as an aggravation of asthma symptoms (such as shortness of breath, cough, wheezing, or chest tightness) that required systemic corticosteroids for at least 3 consecutive days and/or a need for an emergency room visit, hospitalisation due to asthma, or death due to asthma.3 
From a pre-specified pooled analysis across PALLADIUM and IRIDIUM to evaluate benefit of ATECTURA® BREEZHALER® high-dose vs SAL/FLU high-dose in patients with uncontrolled asthma.
§Very common AEs affect >1/10;
Common AEs affect between >1/100 to <1/10. ATECTURA BREEZHALER high-dose = IND/MF 150/320 μg (once-daily); ATECTURA BREEZHALER medium-dose = IND/MF 150/160 μg (once-daily); MF high-dose = MF 800 μg (twice-daily); MF medium-dose = MF 400 μg (once-daily).1

Indication: ATECTURA BREEZHALER is indicated as a maintenance treatment of asthma in adults and adolescents 12 years of age and older not adequately controlled with inhaled corticosteroids and inhaled short-acting beta2-agonists.2

ACQ-7, Asthma Control Questionnaire-7; AE, adverse event; CI, confidence interval; FEV1, forced expiratory volume in 1 second; ICS, inhaled corticosteroid; IND, indacaterol acetate; LABA, long-acting beta2-agonist; MF, mometasone furoate; MMRM, mixed model for repeated measures; SABA, long-acting beta2-agonist; SAE, serious adverse event; SAL/FLU, salmeterol/fluticasone propionate.

References

  1. Kornmann O, et al. Respiratory Medicine 2020;161:105809 [Epub ahead of print].
  2. van Zyl-Smit RN et al. Lancet Respir Med 2020;8(10):987–999.
  3. ATECTURA BREEZHALER Summary of Product Characteristics.
  4. van Zyl-Smit RN et al. Lancet Respir Med 2020;8(10):987–999 (supplementary appendix).
  5. Chapman K, et al. 2020, abstract.
     
ATE20-C002 November 2020.
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Adverse events should be reported. Reporting forms and information can be found at yellowcard.mhra.gov.uk. Adverse events should also be reported to Novartis via [email protected] or online through the pharmacovigilance intake (PVI) tool at http://www.report.novartis.com/
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