Diagnosis & Management

Diagnosis of COPD

Spirometric Classification

Even though 12 million adults are suffering from Chronic Obstructive Pulmonary Disease (COPD), an additional 12 million have evidence of impaired lung function.22 Yet, the actual prevalence is not easy to quantify because of imprecise and varying definitions of the disease and because early disease is not always recognized.1 A low rate of disease identification is seen in the fact that fewer than 50% of individuals with COPD (based on airflow limitation) have a diagnosis of COPD.23

For a diagnosis of COPD, there must be a ratio of Forced Expiratory Volume (FEV1) to Forced Vital Capacity (FVC) of less than 70% after bronchodilator treatment.1 There is spirometric classification of the four stages of COPD severity:1

Disease Management

Disease management is possible with therapy at each stage of COPD and should include the following goals:1

  • Relieve symptoms
  • Prevent disease progression
  • Improve exercise tolerance
  • Improve health status
  • Prevent and treat complications
  • Prevent and treat exacerbations
  • Reduce mortality

Components of Care

The following components of care are based on Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines and are important considerations for you and your patients:

Assess and monitor disease. Identify symptoms, such as dyspnea, chronic cough, chronic sputum production, and determine a history of exposure to risk factors.1

Reduce risk factors. Tobacco smoke is recognized as the most common risk factor for COPD, but others include occupational exposure to dust, fumes, or gases; indoor and outdoor air pollution; and irritants. Smoking cessation programs should be encouraged for all individuals who smoke.1 Consider a regular schedule for immunizations to help your patients avoid getting the flu and pneumonia.1

Manage stable COPD. Take into account these factors:1

  • Severity of airflow limitation
  • Frequency and severity of exacerbations
  • Presence of ≥1 complications
  • Presence of respiratory failure
  • Presence of comorbid conditions
  • General health status
  • Number of medications needed to manage the disease

Manage exacerbations. The impact of exacerbations is significant. Patients may require several weeks for symptoms and lung function to recover to baseline values. The most common causes of exacerbation are infection of the tracheobronchial tree and air pollution.1

Disease Management with Nebulization

Rapid, sustained and consistent bronchodilation can be achieved for residents in long-term care settings, for patients in hospitals and for those being treated at home.2,12,13 The inhalation device delivers medication with simple, tidal breathing that requires little or no coordination or cooperation.3,12 The convenience of nebulization makes it one of the most versatile and effective methods of treatment available today.2,3,12,13

Nebulization is effective across disease severity and care settings.2,12,13 For a successful maintenance treatment strategy in COPD, the device could make the difference in certain patients.

Please see accompanying full Prescribing Information, including Boxed Warning.

Indication

PERFOROMIST® (formoterol fumarate) Inhalation Solution is indicated for the long-term, twice-daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.

Important Limitations for Use:

  • It is not indicated to treat acute deteriorations of COPD
  • It is not indicated to treat asthma. The safety and effectiveness of PERFOROMIST Inhalation Solution in asthma has not been established.

WARNING: ASTHMA-RELATED DEATH

Long-acting beta2-adrenergic agonists (LABA) increase the risk of asthma-related death. Data from a large placebo-controlled US study that compared the safety of another long-acting beta2-adrenergic agonist (salmeterol) or placebo added to usual asthma therapy showed an increase in asthma-related deaths in patients receiving salmeterol. This finding with salmeterol is considered a class effect of LABA, including formoterol, the active ingredient in PERFOROMIST Inhalation Solution.
The safety and efficacy of PERFOROMIST in patients with asthma have not been established. All LABA, including PERFOROMIST, are contraindicated in patients with asthma without use of a long-term asthma control medication.

Important Safety Information

PERFOROMIST Inhalation Solution like other LABAs is contraindicated in patients with asthma without use of a long term asthma control medication.

PERFOROMIST Inhalation Solution should not be initiated in patients with acutely deteriorating COPD, which may be a life-threatening condition. PERFOROMIST Inhalation Solution should not be used for the relief of acute symptoms, i.e., as rescue therapy for the treatment of acute episodes of bronchospasm.

As with other inhaled beta2-agonists, PERFOROMIST Inhalation Solution can produce paradoxical bronchospasm that may be life-threatening. If paradoxical bronchospasm occurs, PERFOROMIST Inhalation Solution should be discontinued immediately and alternative therapy instituted.

PERFOROMIST Inhalation Solution should not be used more often, at higher doses than recommended, or in conjunction with other inhaled, long-acting beta2-agonists, as an overdose may result. Clinically significant cardiovascular effects and fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs.

PERFOROMIST Inhalation Solution should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension; in patients with convulsive disorders or thyrotoxicosis; and in patients who are unusually responsive to sympathomimetic amines.

PERFOROMIST Inhalation Solution, like other beta2-agonists, can produce a clinically significant cardiovascular effect in some patients as measured by increases in pulse rate, systolic and/or diastolic blood pressure, and/or symptoms.

PERFOROMIST Inhalation Solution, like other sympathomimetic amines, should be used with caution. Doses of the related beta2-agonist albuterol, when administered intravenously, have been reported to aggravate preexisting diabetes mellitus and ketoacidosis.

Beta agonist medications may produce significant hypokalemia in some patients, which has the potential to produce adverse cardiovascular effects. The decrease in serum potassium is usually transient, not requiring supplementation.

Immediate hypersensitivity reactions may occur after administration of PERFOROMIST Inhalation Solution, as demonstrated by cases of anaphylactic reactions, urticaria, angioedema, rash, and bronchospasm.

PERFOROMIST Inhalation Solution, as with other beta2-agonists, should be used with extreme caution in patients being treated with monoamine oxidase inhibitors, tricyclic antidepressants, or drugs known to prolong the QTc interval because the action of adrenergic agonists on the cardiovascular system may be potentiated by these agents.

Beta-blockers and formoterol fumarate may inhibit the effect of each other when administered concurrently. Therefore, patients with COPD should not normally be treated with beta-blockers except under certain circumstances e.g., as prophylaxis after myocardial infarction, there may be no acceptable alternatives to the use of beta-blockers in patients with COPD.

Concomitant treatment with Xanthine derivatives, steroids, or diuretics may potentiate any hypokalemic effect of adrenergic agonists. The EKG changes and/or hypokalemia that may result from the administration of non-potassium sparing diuretics (such as loop or thiazide diuretics) can be acutely worsened by beta-agonists, so caution is advised in the co-administration.

You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.