Efficacy vs BREO (an ICS/LABA)

Help release your adult patients with ASTHMA—who are symptomatic on an ICS/LABA—from the bronchoconstriction of ASTHMA

TRELEGY is NOT for the relief of acute bronchospasm.
CAPTAIN evaluated TRELEGY vs BREO in a 24- to 52-week trial in adult patients with asthma.1

TRELEGY: better breathing vs an ICS/LABA1

5X greater lung function improvement vs BREO (an ICS/LABA)1

 

Primary endpoint with TRELEGY 100: change from baseline in trough FEV1 at Week 241

TRELEGY 100

Primary endpoint ling graph 1
Primary endpoint ling graph 1
  • CAPTAIN study description1

    Design: A 24- to 52-week, randomized, double-blind, active-controlled, parallel-group, multicenter study that evaluated the safety and efficacy of TRELEGY 100 and TRELEGY 200 compared with BREO 100 and BREO 200, respectively (each administered once daily in the morning).

    Patients: Patients aged 18 years or older were eligible if they had inadequately controlled asthma (ie, ACQ-6 score ≥1.5) while receiving daily ICS/LABA (ICS dose >250 mcg FP or equivalent) for ≥12 weeks pre-study. Patients randomized to treatment (N=2436; mean age: 53 years; mean prebronchodilator percent predicted FEV1: 58.5% at screening and 68.2% at randomization) had completed a 5-week run-in and stabilization period in which they received twice-daily ADVAIR 250/50 for 3 weeks followed by once-daily BREO 100 for 2 weeks. 

    During the 5-week run-in/stabilization period, patients had a mean trough FEV1 improvement of 287 mL. Despite improvement in FEV1, 93% were not well controlled (mean ACQ-6 score of 1.9), demonstrating the need for additional therapy.

 
 
 

TRELEGY 100 vs BREO 200 (higher-dose ICS/LABA)1

  • See descriptive results

    Descriptive Results

    In the CAPTAIN study, the change from baseline in trough FEV1 at Week 24 was 134 mL for TRELEGY 100 (n=406) vs 76 mL for BREO 200 (n=406).1

    *The comparison of TRELEGY 100 vs BREO 200 was not in the predefined testing hierarchy, and the difference reflects rounding.1

  • CAPTAIN study description1

    Design: A 24- to 52-week, randomized, double-blind, active-controlled, parallel-group, multicenter study that evaluated the safety and efficacy of TRELEGY 100 and TRELEGY 200 compared with BREO 100 and BREO 200, respectively (each administered once daily in the morning).

    Patients: Patients aged 18 years or older were eligible if they had inadequately controlled asthma (ie, ACQ-6 score ≥1.5) while receiving daily ICS/LABA (ICS dose >250 mcg FP or equivalent) for ≥12 weeks pre-study. Patients randomized to treatment (N=2436; mean age: 53 years; mean prebronchodilator percent predicted FEV1: 58.5% at screening and 68.2% at randomization) had completed a 5-week run-in and stabilization period in which they received twice-daily ADVAIR 250/50 for 3 weeks followed by once-daily BREO 100 for 2 weeks. 

    During the 5-week run-in/stabilization period, patients had a mean trough FEV1 improvement of 287 mL. Despite improvement in FEV1, 93% were not well controlled (mean ACQ-6 score of 1.9), demonstrating the need for additional therapy.

 
 
 

Superior lung function improvement vs BREO (an ICS/LABA)1

 
Primary endpoint with TRELEGY 200: change from baseline in trough FEV1 at Week 241

TRELEGY 200

Primary endpoint line graph 2
Primary endpoint line graph 2
  • CAPTAIN study description1

    Design: A 24- to 52-week, randomized, double-blind, active-controlled, parallel-group, multicenter study that evaluated the safety and efficacy of TRELEGY 100 and TRELEGY 200 compared with BREO 100 and BREO 200, respectively (each administered once daily in the morning).

    Patients: Patients aged 18 years or older were eligible if they had inadequately controlled asthma (ie, ACQ-6 score ≥1.5) while receiving daily ICS/LABA (ICS dose >250 mcg FP or equivalent) for ≥12 weeks pre-study. Patients randomized to treatment (N=2436; mean age: 53 years; mean prebronchodilator percent predicted FEV1: 58.5% at screening and 68.2% at randomization) had completed a 5-week run-in and stabilization period in which they received twice-daily ADVAIR 250/50 for 3 weeks followed by once-daily BREO 100 for 2 weeks. 

    During the 5-week run-in/stabilization period, patients had a mean trough FEV1 improvement of 287 mL. Despite improvement in FEV1, 93% were not well controlled (mean ACQ-6 score of 1.9), demonstrating the need for additional therapy.

TRELEGY: annualized rate of exacerbations*

Descriptive Pooled Results: Exacerbations over 52 weeks1
The mean annualized rate of exacerbations was 0.31 for both TRELEGY (100 and 200; n=814) and for BREO (100 and 200; n=813), with a 2.6% reduction in rate (95% CI: -26.2, 24.9) with TRELEGY compared with BREO.

Among Patients on TRELEGY (100 and 200) or BREO (100 and 200)

*Exacerbation defined as deterioration of asthma requiring the use of systemic corticosteroid (or at least a doubling of maintenance dose) for at least 3 days, or an in-patient hospitalization or emergency department visit due to asthma that required systemic corticosteroid.

This endpoint was not in the predefined testing hierarchy, and results are descriptive.1

In the 1 year prior to study entry, 63% of subjects reported having exacerbations that required oral/systemic corticosteroids and/or hospitalization.1

  • CAPTAIN study description1

    Design: A 24- to 52-week, randomized, double-blind, active-controlled, parallel-group, multicenter study that evaluated the safety and efficacy of TRELEGY 100 and TRELEGY 200 compared with BREO 100 and BREO 200, respectively (each administered once daily in the morning).

    Patients: Patients aged 18 years or older were eligible if they had inadequately controlled asthma (ie, ACQ-6 score ≥1.5) while receiving daily ICS/LABA (ICS dose >250 mcg FP or equivalent) for ≥12 weeks pre-study. Patients randomized to treatment (N=2436; mean age: 53 years; mean prebronchodilator percent predicted FEV1: 58.5% at screening and 68.2% at randomization) had completed a 5-week run-in and stabilization period in which they received twice-daily ADVAIR 250/50 for 3 weeks followed by once-daily BREO 100 for 2 weeks.

    During the 5-week run-in/stabilization period, patients had a mean trough FEV1 improvement of 287 mL. Despite improvement in FEV1, 93% were not well controlled (mean ACQ-6 score of 1.9), demonstrating the need for additional therapy.

Asthma Control Questionnaire responder rate
Favoring TRELEGY

The ACQ-7 incorporates 5 questions on symptoms and impacts, rescue bronchodilator use, and lung function (FEV1).2
 

Descriptive un-pooled analysis: ACQ-7 responder rates at Week 241‡

In a descriptive pooled analysis, the ACQ-7 responder rate was 63% (498/795) for TRELEGY 100 and TRELEGY 200 compared with 55% (436/793) for BREO 100 and BREO 200 at Week 24, favoring TRELEGY (OR: 1.43; 95% CI: 1.16, 1.76).1  

An ACQ responder was defined as a patient who had an ACQ total score decrease of ≥0.5 from baseline at Week 24.1  

This endpoint was not in the predefined testing hierarchy, and results are descriptive.1

  • CAPTAIN study description1

    Design: A 24- to 52-week, randomized, double-blind, active-controlled, parallel-group, multicenter study that evaluated the safety and efficacy of TRELEGY 100 and TRELEGY 200 compared with BREO 100 and BREO 200, respectively (each administered once daily in the morning).

    Patients: Patients aged 18 years or older were eligible if they had inadequately controlled asthma (ie, ACQ-6 score ≥1.5) while receiving daily ICS/LABA (ICS dose >250 mcg FP or equivalent) for ≥12 weeks pre-study. Patients randomized to treatment (N=2436; mean age: 53 years; mean prebronchodilator percent predicted FEV1: 58.5% at screening and 68.2% at randomization) had completed a 5-week run-in and stabilization period in which they received twice-daily ADVAIR 250/50 for 3 weeks followed by once-daily BREO 100 for 2 weeks.

    During the 5-week run-in/stabilization period, patients had a mean trough FEV1 improvement of 287 mL. Despite improvement in FEV1, 93% were not well controlled (mean ACQ-6 score of 1.9), demonstrating the need for additional therapy.

  • Measuring control with the Asthma Control Questionnaire (ACQ-7)

    The ACQ-7 incorporates 5 questions on symptoms and impacts, rescue bronchodilator use, and lung function (FEV1 % predicted).2  

    Nighttime awakenings due to asthma

    Daily activity limitations due to asthma

    Wheezing frequency

    Asthma symptoms on waking

    Shortness of breath due to asthma

    SABA use

    FEV1

 

TRELEGY in ASTHMA: data from CAPTAIN, a study of 24 to 52 weeks' duration

Go to Adverse Reactions to see a table of all adverse reactions with ≥1% incidence. 

 

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