Efficacy
Secondary endpoints
In a clinical study1 in patients with asthma previously uncontrolled on a medium-dose ICS, the coprimary endpoints were FEV1 AUC (0-12 hr) and clinically judged deterioration in asthma or reductions in lung function (asthma flare-ups).
Proportion of nights with nocturnal awakenings, change in total rescue medication use, and asthma-specific quality of life were secondary endpoints.
All study medications were administered as 2 inhalations twice daily.
Nocturnal awakenings: 60% reduction with DULERA vs 15% with placebo
In a clinical study in patients with asthma previously uncontrolled on a medium-dose ICS, DULERA demonstrated significant reduction in the proportion of nights with nocturnal awakeningsg vs placebo through 6 months (P<0.001).1
(g) The proportion of nights with nocturnal awakenings due to asthma requiring rescue medication use (secondary endpoint), where baseline was the proportion of nights with nocturnal awakenings during the week before first treatment dose.
Treatment | Reduction |
---|---|
DULERA 100 mcg/5 mcg (n=186) | Reduction of 60% from baseline (0.18) at endpoint |
Placebo (n=194) | Reduction of 15% from baseline (0.15) at endpoint |
Rescue medication: Reduced nearly 2 puffs per day with DULERA vs placebo (P<0.001)1,2
Treatment | Reduction |
---|---|
DULERA 100 mcg/5 mcg (n=186) | Reduction of –0.6 puffs/day from baseline (2.02 puffs/day) at endpoint. |
Placebo (n=195) | Increase of 1.1 puffs/day from baseline (1.95 puffs/day) at endpoint. |
DULERA is NOT a rescue medication and does NOT replace fast-acting inhalers to treat acute symptoms.
Asthma-specific quality of life: DULERA demonstrated a clinically meaningful improvement on the subjective impact of asthma on patients’ health-related quality of life as measured by the AQLQ(S)1
AQLQ(S) results:
- A change from baseline ≥0.5 points is considered a clinically meaningful improvement.
- The mean difference in AQLQ(S) between patients taking DULERA 100 mcg/5 mcg and placebo was 0.5 points (95% CI: 0.32, 0.68).
- Measurement is based on a 7-point scale where 1 = maximum impairment and 7 = no impairment.
Study design
In a 26-week, placebo-controlled study of 781 patients ≥ 12 years of age comparing DULERA 100 mcg/5 mcg (n = 191), mometasone furoate 100 mcg (n = 192), formoterol fumarate 5 mcg (n=202), and placebo (n = 196), each administered as 2 inhalations twice daily by metered-dose inhalation aerosols. All other maintenance therapies were discontinued. This study included a 2- to 3-week run-in period with mometasone furoate 100 mcg, 2 inhalations twice daily. Patients had persistent asthma that was not well controlled on a medium dose of ICS prior to randomization. All treatment groups were balanced with regard to baseline characteristics. This trial included patients ranging from 12 to 76 years of age, 41% male and 59% female, and 72% Caucasian and 28% non-Caucasian. The coprimary endpoints were FEV1 AUC (0–12 hr) and clinically judged deterioration in asthma or reductions in lung function (asthma flare-ups).1
Definitions
AQLQ(S) = Asthma Quality of Life Questionnaire (standardized)
AUC = area under the curve
CI = confidence interval
FEV1 = forced expiratory volume in 1 second
ICS = inhaled corticosteroid
QoL = quality of life
References
1. Nathan RA, Nolte H, Pearlman DS; for P04334 Study Investigators. Twenty-six-week efficacy and safety study of mometasone furoate/formoterol 200/10 μg combination treatment in patients with persistent asthma previously receiving medium-dose inhaled corticosteroids. Allergy Asthma Proc. 2010;31(4):269–279.
2. Data available on request from Merck, Professional Services-DAP, WPI-27, PO Box 4, West Point, PA 19486-0004. Please specify information package US-XFV-00170.