Asthma/COPD:
Indications for: PERFOROMIST
Long-term maintenance treatment of bronchoconstriction in COPD, including chronic bronchitis and emphysema.
Limitations of Use:
Not indicated to treat acute deteriorations of COPD or for treatment of asthma.
Clinical Trials:
Perforomist Inhalation Solution was evaluated in a 12-week, double-blind, placebo- and active-controlled, randomized, parallel-group, multicenter trial conducted in the US.
Patient demographics: (N=351)
-
Age range: 40-86 years; mean age 63 years
-
Mean FEV1: 1.34L (44% of predicted)
-
58% of patients had bronchodilator reversibility, defined as a 10% or greater increase in FEV1 after inhalation of 2 actuations (180mcg of albuterol from a metered dose inhaler)
-
About 86% (106) of patients treated with Perforomist and 74% (84) of placebo patients completed the trial
Patients were randomly assigned to Perforomist 20 mcg (n=123) or placebo (n=114), administered twice daily via a PARI-LC Plus® nebulizer with a PRONEB® Ultra compressor.
Perforomist 20mcg twice daily resulted in significantly greater post-dose bronchodilation (as measured by serial FEV1 for 12 hours post-dose; the primary efficacy analysis) compared to placebo when evaluated at endpoint (week 12 for completers and last observation for dropouts). Similar results were seen on Day 1 and at subsequent time points during the trial.
Patients treated with Perforomist Inhalation Solution used less rescue albuterol during the trial compared to patients treated with placebo.
Examination of age (≥65 or younger) and gender subgroups did not identify differences in response to Perforomist Inhalation Solution. There were too few non-Caucasian subjects to assess differences in populations defined by race adequately.
In the 12-week study, 78% of patients achieved a 15% increase from baseline FEV1 after the first dose of Perforomist 20 mcg. The median time to onset of bronchodilation, defined as 15% increase in FEV1, was 11.7 minutes. Following dosing, the time to onset of bronchodilation was 13.1 minutes when defined as an increase in FEV1 of 12% and 200 mL. The median time to peak bronchodilator effect was 2 hours after dosing.
Adult Dosage:
20mcg (1 vial) by nebulizer twice daily (AM & PM). Use standard jet nebulizer (eg, PARI-LC Plus [with face-mask or mouthpiece]) and air compressor (eg, Proneb Ultra compressor). Does not need to be diluted before nebulization. Do not mix with other drugs.
Children Dosage:
Not established.
PERFOROMIST Contraindications:
Use of LABA without inhaled corticosteroid (ICS) in asthma.
PERFOROMIST Warnings/Precautions:
LABA as monotherapy (without ICS) for asthma can increase risk of asthma-related events. Do not initiate in acute deteriorating COPD. Not for relief of acute symptoms. Prescribe a short-acting, inhaled β2-agonist for acute symptoms; monitor for increased need. Do not exceed recommended dose. Cardiovascular disease (esp. hypertension, coronary insufficiency, arrhythmias). Convulsive disorders. Thyrotoxicosis. Hyperresponsiveness to sympathomimetics. Diabetes. Ketoacidosis. Hypokalemia. Pregnancy. Labor & delivery. Nursing mothers.
PERFOROMIST Classification:
Long-acting beta-2 agonist (LABA).
PERFOROMIST Interactions:
Caution with concomitant other adrenergic drugs; may potentiate sympathetic effects. Extreme caution with MAOIs, tricyclics, or others that prolong QTc interval (may cause ventricular arrhythmias). Antagonized by β-blockers. K+-depleting diuretics, xanthines, steroids may potentiate hypokalemia.
Adverse Reactions:
GI upset, nasopharyngitis, dry mouth, dizziness, insomnia; ECG changes or cardiovascular effects (eg, increased BP, tachycardia; consider discontinuing if occur); hypokalemia, hyperglycemia, metabolic acidosis; hypersensitivity reactions; rarely: paradoxical bronchospasm.
Drug Elimination:
Renal. The mean terminal elimination half-life was determined to be 7 hours.
Generic Drug Availability:
YES
How Supplied:
Single-use vials (2mL)—30, 60
