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. 2023 Aug 2;10:1225654. doi: 10.3389/fcvm.2023.1225654

Table 1.

Summary of pharmacokinetic studies in special patient populations.

Study Study design Evaluation Results
Effects on ventricular repolarization Placebo-controlled prospective safety studies of continuous ECG monitoring in patients with coronary artery disease
  • • 

    3-way crossover study of placebo and 2 doses of Lumason® (0.1 and 0.5 ml/kg)

  • • 

    4-way crossover study to evaluate cardiac electrophysiology during insonation of the heart at low (0.4–0.5) and high (1.5–1.6) mechanical index

 Continuous 12-lead ECG collected from 3 h pre-dose to 12 h post-dose following each administration of study agent No detrimental effects of Lumason® on cardiac electrophysiology were observed
Patients with pulmonary hypertension or congestive heart failure Single center, randomized placebo-controlled studies to evaluate the effects of iv bolus injections of Lumason® on pulmonary hemodynamics and cardiac function in patients with
  • • 

    normal or elevated baseline MPAP scheduled for right heart catheterization as part of routine evaluation

  • • 

    congestive heart failure

 PVR, MPAP, PCWP monitored by right heart catheterization predose and up to 10 min post-dose. Cardiac function and O2 saturation were measured No significant effects on pulmonary hemodynamics after Lumason® or placebo were observed and no differences between 2-ml and 4-ml doses were seen
Patients with COPD Single-center, single-blind, crossover, placebo-controlled study of 4 ml bolus iv Lumason® injection in patients with moderate to severe COPD and forced expiratory volume (FEV1) <70% Pulmonary function (FVC, FEV1 and FEF25−75%) measured at time points up to 5 h post-dose No effect of Lumason® on pulmonary function tests, O2 saturation, ECG, or laboratory tests was observed
Patients with DIPF Single-center, phase I study to evaluate the pharmacokinetics and safety of a single iv bolus injection of Lumason 0.3 ml/kg in patients with DIPF O2 saturation through 1-hour post-dose No changes or clinically meaningful trends observed in O2 saturation or other safety parameters

PVR, pulmonary vascular resistance; MPAP, pulmonary arterial pressure; PCWP, pulmonary capillary wedge pressure; FEV, forced expiratory volume; FVC, forced vital capacity; FEF, forced mid-expiratory flow; COPD, chronic obstructive pulmonary disease; DIPF, diffuse interstitial pulmonary fibrosis.