Clinical Trial Search

Primary: Change From Baseline in 1-hour Morning Post-dose Dose Forced Expiratory Volume in 1 Second (FEV1) of AB/FF 400/12 μg Compared to AB 400 μg at Week 24 — 0.253; 0.169…

Primary: Change in HbA1c From Baseline to Week 28 — -0.96; -0.22 Percentage of HbA1c — p=<0.001

Primary: Number of Participants With Treatment-related Treatment-emergent Adverse Events as Graded According to the Common Terminology Criteria for Adverse Events v4.02 (CTCAE)…

Primary: Contrast to Noise Ratio (CNR) Difference — -10.59; 2.18; 8.66; 14.45 Ratio — p=0.1858

Primary: Achievement of a ≥ 30% Reduction in Mean PTH From Baseline to During the Efficacy Assessment Phase at Month 6 (Weeks 22 to 26) — 96; 58; 57; 93 participants — p=<0.0001

Primary: Aggregated Pathology Score — 7.88; 8.15 Score on a scale

Primary: Change From Baseline (CFB) in Total Corneal Fluorescein Staining (tCFS) at Day 57 — -2.0; -1.0 units on a scale

Primary: Change in Endogenous Glucose Production (EGP) — 2.45; 2.56; 1.95; 2.4 mg/kg*min

Primary: Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) — 3.7; 9.2; 4.3; 7.7 ETDRS letters

Primary: Mean Change in Fluorescein Staining Score From Baseline — -0.95; -1.34; -1.55 points — p=0.004

Primary: Change From Baseline in HbA1c (Hemoglobin A1C) at Week 24 — -2.38; -1.49 Percent — p=<0.001

Primary: Cohort 1: Percent Change From Baseline in Plasma Glucose Area Under the Concentration-time Curve From Time 0 to 4 Hours (AUC0-4h) by Mixed-meal Tolerance Test (MMTT) to…

Primary: Number of Participants With Treatment Emergent Adverse Events — 120 Participants

Primary: Change From Baseline in 24-hour Weighted Mean Plasma Glucose — -34.9; -28.6; -9.0 mg/dL — p=<0.001

Primary: Percentage of Eyes With Anterior Chamber Cell Grade 0 — 65 percentage of eyes

Primary: Factor IX Activity Levels — 30.6 Factor IX activity (%)

Primary: Time to Worsening of DME Disease Activity in the Study Eye. — 82.1; 96.1; 19.1 Weeks