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.
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.
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.
Use of LABA without inhaled corticosteroid (ICS) in asthma.
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.
Long-acting beta-2 agonist (LABA).
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.
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.
Renal. The mean terminal elimination half-life was determined to be 7 hours.
Generic Drug Availability:
Single-use vials (2mL)—30, 60