Efficacy vs SYMBICORT + SPIRIVA (an ICS/LABA + LAMA)

Help patients with COPD breathe better with TRELEGY, the first & only once-daily, single-inhaler triple therapy
Once-daily TRELEGY (a single-inhaler ICS/LABA/LAMA) was evaluated vs triple therapy with 2 inhalers—SYMBICORT (an ICS/LABA) + SPIRIVA HANDIHALER (a LAMA)—in 2 replicate 12‑week, randomized, double-blind, triple-dummy, parallel-group, noninferiority studies.1

Lung function efficacy over 24 hours

Once-daily TRELEGY demonstrated comparable lung function improvement to SYMBICORT + SPIRIVA (an ICS/LABA + LAMA)1

Primary efficacy endpoint: In Study 207608, TRELEGY (n=282) demonstrated noninferiority to SYMBICORT + SPIRIVA (n=272) on the change from baseline in weighted mean FEV1 (0 to 24 hours) at Week 12 (45 mL vs 30 mL; 15-mL difference). Study 207609 demonstrated similar results: TRELEGY (n=274) 39 mL vs SYMBICORT + SPIRIVA (n=277) 29 mL; 11-mL difference. (Difference reflects rounding.)1

 

Change from baseline in serial FEV1 over 24 hours at Week 121,2

Results are descriptive only.
Study 207609
graph 207609 week12
Study 207609 Chart

TRELEGY 100/62.5/25
(n=348)

SYMBICORT 160/4.5 + SPIRIVA HANDIHALER 18
(n=348)

Serial FEV1 was not defined as a formal endpoint, so results are descriptive only. These data were used to calculate the primary endpoint, which was change from baseline in weighted mean FEV1 (0 to 24 hours) at Week 12.

 

Change from baseline in serial FEV1 over 24 hours at Week 121,2

Results are descriptive only.
Study 207608
graph 207608 week12
study 207608 chart

TRELEGY 100/62.5/25
(n=348)

SYMBICORT 160/4.5 + SPIRIVA HANDIHALER 18
(n=342).

Serial FEV1 was not defined as a formal endpoint, so results are descriptive only. These data were used to calculate the primary endpoint, which was change from baseline in weighted mean FEV1 (0 to 24 hours) at Week 12.

  • TRELEGY vs SYMBICORT + SPIRIVA study description1,2

    Design: Two replicate 12-week, randomized, double-blind, triple-dummy, parallel-group, multicenter studies were conducted to evaluate the efficacy and safety of TRELEGY 100/62.5/25 mcg vs SYMBICORT Inhalation Aerosol 160/4.5 mcg (MDI) plus SPIRIVA HANDIHALER 18 mcg after 12 weeks of treatment. 

    Patients were eligible if they were symptomatic with a postbronchodilator FEV1 <50% predicted normal or an FEV1 <80% predicted normal and a documented history of ≥2 moderate exacerbations or 1 severe (hospitalized) exacerbation in the previous 12 months.

    Following screening, eligible patients:

    • Entered a 4-week run-in period with an open label triple regimen of SYMBICORT (two inhalations, twice daily) + SPIRIVA (two inhalations, once daily)
    • Were then randomized to receive TRELEGY once daily in the morning or a combination of SYMBICORT twice daily plus SPIRIVA HANDIHALER once daily

    Patients: In both studies, patients with COPD had a mean age of 65 years (N=728 for 207608; N=732 for 207609), a mean postbronchodilator predicted FEV1 of 42% and a mean postbronchodilator FEV1/FVC ratio of 0.48. Approximately 46% of the patients had no moderate to severe exacerbations in the 12 months prior to screening.

 
 
 

Lung function efficacy at 3 months

Once-daily TRELEGY vs twice-daily SYMBICORT (an ICS/LABA) + once-daily SPIRIVA (a LAMA)1
 

Secondary endpoint: change from baseline in trough FEV1 at Day 851,2

Results are descriptive only.
Study 207609
study 207609

TRELEGY 100/62.5/25 (n=343)

SYMBICORT 80/4.5 + SPIRIVA HANDIHALER 18 (n=342)

 

Secondary endpoint: change from baseline in trough FEV1 at Day 851,2

Results are descriptive only.
Study 207608
study 207608
study 207608 chart day 85

TRELEGY 100/62.5/25 (n=343)

SYMBICORT 80/4.5 + SPIRIVA HANDIHALER 18 (n=342)

  • TRELEGY vs SYMBICORT + SPIRIVA study description1,2

    Design: Two replicate 12-week, randomized, double-blind, triple-dummy, parallel-group, multicenter studies were conducted to evaluate the efficacy and safety of TRELEGY 100/62.5/25 mcg vs SYMBICORT Inhalation Aerosol 160/4.5 mcg (MDI) plus SPIRIVA HANDIHALER 18 mcg after 12 weeks of treatment. 

    Patients were eligible if they were symptomatic with a postbronchodilator FEV1 <50% predicted normal or an FEV1 <80% predicted normal and a documented history of ≥2 moderate exacerbations or 1 severe (hospitalized) exacerbation in the previous 12 months.

    Following screening, eligible patients:

    • Entered a 4-week run-in period with an open label triple regimen of SYMBICORT (two inhalations, twice daily) + SPIRIVA (two inhalations, once daily)
    • Were then randomized to receive TRELEGY once daily in the morning or a combination of SYMBICORT twice daily plus SPIRIVA HANDIHALER once daily

    Patients: In both studies, patients with COPD had a mean age of 65 years (N=728 for 207608; N=732 for 207609), a mean postbronchodilator predicted FEV1 of 42% and a mean postbronchodilator FEV1/FVC ratio of 0.48. Approximately 46% of the patients had no moderate to severe exacerbations in the 12 months prior to screening.

TRELEGY: consistent safety profile in both studies, with low pneumonia incidence comparable to SYMBICORT + SPIRIVA1,2*

In the two 12-week studies, the most commonly reported adverse events with ≥3% incidence in either group were2:

 

TRELEGY 100/62.5/25

(n=729)

%

SYMBICORT 160/4.5 +
SPIRIVA HANDIHALER 18

(n=731)

%

Nasopharyngitis 3 4
COPD 3 1
Headache 2 2
 Signs, symptoms, or progression of COPD are more severe than expected for the subject’s condition.

Pneumonia incidence as reported from adverse events of special interest1,2

TRELEGY 100/62.5/25

(n=729)

%

SYMBICORT 160/4.5 +
SPIRIVA HANDIHALER 18

(n=731)

%

1.0

1.2

*Safety data were descriptive only. The studies were not powered to compare the safety profiles between the treatment arms.

 

TRELEGY provides an ICS, a LABA, and a LAMA in a single inhaler.

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