GOLD Report Strategies for COPD Treatment

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GOLD Report

GOLD recommends prescribing a long-acting bronchodilator for maintenance treatment, with a goal to manage symptoms

  • GOLD recommends using long-acting bronchodilators as a standard of care for COPD maintenance therapy1
  • Use of short-acting bronchodilators for maintenance treatment is generally not recomended
  • >2/3 of COPD patients in clinical practice make at least 1 error using an inhalation device1

GOLD does not endorse any specific treatments. Refer to the GOLD Report for complete recommendations.

The Global Initiative for Chronic Obstructive Lung Disease (GOLD) was launched in 1997 in collaboration with the National Heart, Lung, and Blood Institute, the National Institutes of Health, USA, and the World Health Organization. The GOLD Report is shaped by committees made up of leading experts from around the world. Working with health care professionals and public health officials, GOLD seeks to raise awareness and improve prevention and treatment of COPD.


 

Assess COPD symptoms, exacerbation risk, and patient response to determine initial and follow-up pharmacological treatment

Initial Pharmacological Treatment

Initial pharmacological treatment image

Follow-up Pharmacological Treatment

1. IF RESPONSE TO INITIAL TREATMENT IS APPROPRIATE, MAINTAIN IT

2. IF NOT:

  Consider the predominant treatable trait to target (dyspnea or exacerbations)

  Use exacerbation pathway if both exacerbations and dyspnea need to be targeted

  Place patient in box corresponding to current treatment and follow indications

  Assess response, adjust, and review

  These recommendations do not depend on the ABCD assessment at diagnosis

Follow-up treatment chart

Consider de-escalation of ICS or switch if pneumonia, inappropriate original indication, or lack of response to ICS.
§ Consider if eos ≥300 or eos ≥100 AND ≥2 moderate exacerbations/1 hospitalization.

GOLD does not endorse any specific treatments. Refer to the GOLD Report for complete recommendations.

LAMA=long-acting muscarinic antagonist; LABA=long-acting beta2-adrenergic agonist; ICS=inhaled corticosteroid; eos=blood eosinophil count in cells per microliter; mMRC=modified British Medical Research Council Questionnaire; CAT™=COPD Assessment Test™.

© 2019 Global Strategy for Diagnosis, Management, and Prevention of COPD. All rights reserved. Use is by express license from the owner.


Following implementation of therapy, reassess patients for attainment of treatment goals

GOLD recommends reviewing symptoms, assessing inhalation device technique, and then adjusting pharmacological treatment as needed.1

Management Cycle

Management cycle of COPD flowchart

*Response to escalation should always be reviewed. De-escalation should be considered if there is a lack of clinical benefit and/or side effects.
Including pulmonary rehabilitation and self-management education.

GOLD does not endorse any specific treatments. Refer to the GOLD Report for complete recommendations.

© 2019 Global Strategy for Diagnosis, Management, and Prevention of COPD. All rights reserved. Use is by express license from the owner.


Reference:
1.
 Global strategy for the diagnosis, management and prevention of chronic obstructive pulmonary disease: 2019 report. Global Initiative for Chronic Obstructive Lung Disease (GOLD). 2019:1-139.

 

Important Safety Information & Indication

Important Safety Information

BROVANA is contraindicated in patients with a history of hypersensitivity to arformoterol, racemic formoterol or to any of the ingredients.

Use of a LABA, including BROVANA, without an inhaled corticosteroid is contraindicated in patients with asthma. 

Use of a LABA, including BROVANA, as monotherapy (without inhaled corticosteroids) for asthma increases the risk of serious asthma-related events, including hospitalization, intubation and death. No study adequate to determine whether the rate of asthma-related death is increased in patients treated with BROVANA Inhalation Solution has been conducted. Available data do not suggest an increased risk of death with use of LABAs in patients with COPD.

BROVANA should not be initiated in patients with acutely deteriorating COPD or potentially life-threatening episodes of COPD or used as rescue therapy for acute episodes of bronchospasm. Acute symptoms should be treated with an inhaled short-acting beta2-agonist.

BROVANA should not be used more often, at higher doses than recommended, or in conjunction with other medications containing LABAs as an overdose may result. Patients who have been taking inhaled short-acting beta2-agonists on a regular basis should be instructed to discontinue their regular use and to use them only for symptomatic relief for acute respiratory symptoms. Clinically significant cardiovascular effects and fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs. Patients using BROVANA should not use another medicine containing a LABA for any reason.

Immediate hypersensitivity reactions may occur with BROVANA. If signs occur, discontinue immediately and institute alternative therapy.

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

BROVANA, like other beta2-agonists, can produce a clinically significant cardiovascular effect in some patients as measured by increases in pulse rate, systolic or diastolic blood pressure, and/or symptoms. BROVANA should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension. Beta2-adrenergic agonists may produce significant hypokalemia in some patients.

As with other beta2-agonists, BROVANA, should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors, tricyclic antidepressants, or drugs known to prolong the QTc interval because these agents may potentiate the action of adrenergic agonists on the cardiovascular system.

As with other beta2-agonists, BROVANA should be used with caution in patients treated with additional adrenergic drugs, non-potassium-sparing diuretics, and beta-blockers.

BROVANA, like all medicines containing sympathomimetic amines, should be used with caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, ketoacidosis, and in patients who are unusually responsive to sympathomimetic amines.

Overall efficacy of BROVANA was maintained throughout the 12-week trial duration. Some tolerance to the bronchodilator effect of BROVANA was observed after 6 weeks of dosing (at the end of the dosing interval), although the FEV1 improvement remained statistically significant. This was not accompanied by other clinical manifestations of tolerance.

The five most common adverse events reported with frequency ≥2% in patients taking BROVANA, and occurring more frequently than in patients taking placebo, were pain (8% vs 5%), chest pain (7% vs 6%), back pain (6% vs 2%), diarrhea (6% vs 4%), and sinusitis (5% vs 4%).

BROVANA should not be swallowed as the intended effects on the lungs will not be obtained.  BROVANA is only for oral inhalation via a standard jet nebulizer connected to an air compressor.

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

For additional information, please see full Prescribing Information and Patient Information for BROVANA.

Indication

BROVANA® (arformoterol tartrate) Inhalation Solution is a long-acting beta2- adrenergic agonist (LABA) indicated for the long-term, twice-daily (morning and evening) maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. BROVANA is for use by nebulization only.

Important limitations: BROVANA is not indicated to treat acute deteriorations of COPD and is not indicated to treat asthma.