he Asthma Quality of
Life Questionnaire (AQLQ) for patients age ≥ 18 years or the pediatric AQLQ (PAQLQ) forpatients aged 12-17 were assessed in Trial 1. The responder rate for both measures was definedas an improvement in score of 0.5 or more as threshold. In Trial 1, the responder rate for patients
receiving fluticasone propionate/salmeterol MDPI 55/14 mcg and fluticasonepropionate/salmeterol MDPI 113/14 mcg was 51% and 57% , respectively, compared to 40% for
patients receiving placebo, with an odds ratio of 1.53 (95% CI: 0.93, 2.55) and 2.04 (95% CI:1.23, 3.41), respectively.
Improvements in lung function occurred within 15 minutes of the first dose (15 minutespostdose). Compared to placebo the difference in LS mean change from baseline in FEV1 forfluticasone propionate/salmeterol MDPI 55/14 mcg and 113/14 mcg was 0.216 and 0.164 L ,respectively (unadjusted p-value <0.0001 for both dosages compared with placebo). Refer to
Figure 4 below. Maximum improvement in FEV1 generally occurred within 3 hours forfluticasone propionate/salmeterol MDPI 55/14 mcg and within 6 hours for fluticasone
propionate/salmeterol MDPI 113/14 mcg and improvements were sustained over the 12 hours oftesting at weeks 1 and 12 (Figure 4 and Figure 5). Following the initial dose, predose FEV1relative to day 1 baseline improved markedly over the first week of treatment and the improvement was sustained over the 12 weeks of treatment in the trial. No diminution in the 12
hour bronchodilator effect was observed with either fluticasone propionate/salmeterol MDPI
dose as assessed by FEV1 following 12 weeks of therapy.
Figure 4: Serial Spirometry: Mean Change from Baseline in FEV1 (L) at Day 1 by Time
Point and Treatment Group Trial 1 (FAS; Serial Spirometry Subset)
FS MDPI = fluticasone propionate/salmeterol multidose dry powder inhaler: FP MDPI = fluticasone propionatemultidose dry powder inhaler;FAS = full analysis set; FEV1 = forced expiratory volume in 1 second
Figure 5: Serial Spirometry: Mean Change from Baseline in FEV1 (L) at Week 12 by Time
Point and Treatment Group Trial 1 (FAS; Serial Spirometry Subset)
FS MDPI = fluticasone propionate/salmeterol multidose dry powder inhaler: FP MDPI = fluticasone propionate
multidose dry powder inhaler; FAS = full analysis set; FEV1 = forced expiratory volume in 1 second
Trial 2: In this trial, adolescents and adult patients with persistent symptomatic asthma despiteinhaled corticosteroid (ICS) or ICS/LABA therapy were included. After completing a run-inperiod where patients were treated with single-blind fluticasone propionate MDPI 55 mcg twicedaily replacing their current asthma therapy, patients who met the randomization criteria wererandomized to 1 inhalation twice a day of the following treatments:
Placebo MDPI (n=145)
Fluticasone propionate MDPI 113 mcg (n=146)
Fluticasone propionate MDPI 232 mcg (n=146)
Fluticasone propionate/salmeterol MDPI 113/14 mcg (n=145)
Fluticasone propionate/salmeterol MDPI 232/14 mcg (n=146)
Baseline FEV1 measurements were similar across treatments: fluticasone propionate MDPI113 mcg 2.069 L, fluticasone propionate MDPI 232 mcg 2.075 L, fluticasone
propionate/salmeterol MDPI 113/14 mcg 2.157 L, fluticasone propionate/salmeterol MDPI232/14 mcg 2.083 L, and placebo 2.141 L.
The primary endpoints for this trial were the change from baseline in trough FEV1 at week 12 forall patie |
