Proven Symptom Relief

YUPELRI is the first and only once-daily nebulized LAMA that improves lung function for a full 24 hours of better breathing1,2

on this page:
Study design

The efficacy of once-daily YUPELRI was assessed in two 12-week, randomized, double-blind, placebo-controlled, parallel-group confirmatory studies (Studies 1 and 2) in patients with moderate to very severe COPD.1

24-hour efficacy

Delivers a full 24 hours of lung function improvement in a single nebulized daily dose1

XChart showing difference between YUPELRI and placebo in FEV1 over 24 hours on days 84/85 as described in detail belowTap image to view

In Studies 1 and 2, a prespecified exploratory analysis was performed.25

  • In Study 1, LS mean changes from baseline in FEV1 ranged from 55.8 mL to 240.4 mL in the YUPELRI group, and from -113.6 mL to 59.6 mL in the placebo group.
  • In Study 2, LS mean changes from baseline in FEV1 ranged from 19.8 mL to 148.5 mL in the YUPELRI group, and from -176.4 mL to -13.0 mL in the placebo group

Once-daily
dosing1

24-hour
control1

Response as early as 30 minutes25*

*An exploratory analysis of the time to achieve a 100 mL increase in FEV1 on day 1 showed that the median (95% CI) time to achieve an increase in FEV1 of 100 mL was 30 minutes in Study 1 (30 to 60 minutes) and Study 2 (30 to 90 minutes).

12-week efficacy: pooled data

Delivers consistent control† over 12 weeks for better breathing and symptom relief1,25

XChart showing consistent improvements in trough FEV1 over 12-week study period between YUPELRI vs. placebo as described in detail belowTap image to view

†See below for primary endpoints (Studies 1 and 2).
‡The first measurement was taken at 2 weeks.
§LS mean difference from placebo (SE) is 148.1 mL (16.8). Pooled estimate adjusts the LS mean for placebo as well.

Studies 1 and 2: Primary endpoints1,25

  • In Study 1, LS mean change from baseline in trough FEV1 on day 85 was 127 mL (YUPELRI, N=189) and -19 mL (placebo, N=191), with a statistically significant difference vs placebo of 146 mL (P<0.0001)
  • In Study 2, LS mean change from baseline in trough FEV1 on day 85 was 102 mL (YUPELRI, N=181) and -45 mL (placebo, N=187), with a statistically significant difference vs placebo of 147 mL (P<0.0001)

Studies 1 and 2: Patient characteristics1

  • Mean age of 64 years (range, 41-88 years); mean smoking history of 53 pack-years (48% current smokers); moderate to very severe COPD (mean post-bronchodilator % predicted FEV1 of 55%)
37% of patients studied were on concomitant LABA or ICS/LABA therapy1
12-WEEK EFFICACY POOLED SUBGROUP ANALYSIS

Improved lung function over 12 weeks in concomitant use with LABA or ICS/LABA and as monotherapy25¶

XChart showing LS mean difference in trough FEV1 over 12 weeks concomitant use data between YUPELRI with concomitant LABA or ICS/LABA vs. placebo with concomitant LABA or ICS/LABA as described in detail belowTap image to view

YUPELRI with concomitant LABA or ICS/LABA vs placebo with concomitant LABA or ICS/LABA25¶:

  • LS mean change from baseline in trough FEV1 on day 85 was 111.82 mL (YUPELRI, N=118) vs -27.37 mL (placebo, N=89) (P<0.0001)
  • LS mean difference from placebo was 139.19 mL (95% CI, 82.87-195.51)

YUPELRI only vs placebo only (data not shown in graph above)1:

  • LS mean change from baseline in trough FEV1 on day 85 was 117.66 mL (YUPELRI, N=192) vs -33.27 mL (placebo, N=207) (P<0.0001)
  • LS mean difference from placebo was 150.93 mL (95% CI, 110.26-191.61)

The safety and efficacy of mixing therapies with YUPELRI in a nebulizer have not been established.

HRQoL

Improved patients’ health-related quality of life (HRQoL) as measured by SGRQ

St. George's Respiratory Questionnaire (SGRQ)1,27

SGRQ is a validated, patient-reported, disease-specific instrument designed to measure impact on 3 main components, which comprise a total score.

COPD symptom improvement

Activities of daily living

Social interaction

A change of 4 units' improvement in the SGRQ is considered minimal clinically important difference (MCID).

Table showing information about percentage of patients in the YUPELRI treatment arm who achieved MCID in two studies.Table showing information about percentage of patients in the YUPELRI treatment arm who achieved MCID in two studies.
EXPLORE ADDITIONAL CONTENT

Demonstrated Safety

See how YUPELRI was shown to be well tolerated in clinical trials.1

Learn More

Dosing & Administration

YUPELRI is the only LAMA patients can use with any standard jet nebulizer.1,2

Learn More

CI=confidence interval; COPD=chronic obstructive pulmonary disease; FEV1=forced expiratory volume; GOLD=Global Initiative for Chronic Obstructive Lung Disease; ICS=inhaled corticosteroid; LABA=long-acting beta2-agonist; LAMA=long-acting muscarinic antagonist; LS=least squares.