Adult asthma clinical practice guidelines.

Label

Evidence-Based Recommendations

Evidence-Based (A)

Language: ^a The intervention is strongly recommended for eligible patients.

Evidence: The intervention improves important health outcomes, based on good evidence, and the Guideline Development Team concludes that the benefits substantially outweigh the harms and costs.

Evidence Grade: Good.

Evidence-Based (B)

Language: ^a The intervention is recommended for eligible patients.

Evidence: The intervention improves important health outcomes, based on 1) good evidence that benefits outweigh harms and costs; or 2) fair evidence that benefits substantially outweigh harms and costs.

Evidence Grade: Good or Fair.

Evidence-Based (C)

Language: ^a No recommendation for or against routine provision of the intervention. (At the discretion of the Guideline Development Team, the recommendation may use the language "option," but must list all the equivalent options.)

Evidence: Evidence is sufficient to determine the benefits, harms, and costs of an intervention, and there is at least fair evidence that the intervention improves important health outcomes. But the Guideline Development Team concludes that the balance of the benefits, harms, and costs is too close to justify a general recommendation.

Evidence Grade: Good or Fair.

Evidence-Based (D)

Language: ^a Recommendation against routinely providing the intervention to eligible patients.

Evidence: The Guideline Development Team found at least fair evidence that the intervention is ineffective, or that harms or costs outweigh benefits.

Evidence Grade: Good or Fair.

Evidence-Based (I)

Language: ^a The evidence is insufficient to recommend for or against routinely providing the intervention. (At the discretion of the Guideline Development Team, the recommendation may use the language "option," but must list all the equivalent options.)

Evidence: Evidence that the intervention is effective is lacking, of poor quality, or conflicting and the balance of benefits, harms, and costs cannot be determined.

Evidence Grade: Insufficient.

Consensus-Based

Language: ^a The language of the recommendation is at the discretion of the Guideline Development Team, subject to approval by the National Guideline Directors.

Evidence: The level of evidence is assumed to be "Insufficient" unless otherwise stated. However, do not use the A, B, C, D, or I labels, which are intended only to be used for evidence-based recommendations.

Evidence Grade: Insufficient, unless otherwise stated.

For the rare consensus-based recommendations that have "Good" or "Fair" evidence, the evidence must support a different recommendation, because if the evidence were good or fair, the recommendation would usually be evidence-based. In this kind of consensus-based recommendation, the evidence grade should point this out (e.g., "Evidence Grade: Good, supporting a different recommendation.")

Definitions of the levels of evidence (evidence-based A-D, I and consensus-based) are provided at the end of the "Major Recommendations" field.

Stepwise Medical Management of Persistent Asthma
1. First-Line Drug Therapy For Patients With Persistent Asthma
  1. It is strongly recommended that patients with persistent asthma be started on a low to medium dose of inhaled corticosteroid (ICS) as a first-line treatment. (Evidence-Based: A)
  2. Inhaled long-acting beta-agonists (LABA), leukotriene antagonists, cromolyn sodium, or nedocromil are NOT recommended as first-line drug therapy. (Evidence-Based: D)
1. Second-Line Drug Therapy for Patients with Persistent Asthma
  1. An inhaled long-acting beta-agonist (LABA) combined with an inhaled corticosteroid (ICS) is strongly recommended for patients whose persistent asthma is chronically uncontrolled on ICS alone (Refer to the section "Assessing Asthma Control in Patients with Asthma" below). (Evidence-Based: A)
  2. Leukotriene antagonists are an option for those who cannot tolerate or do not respond to long-acting beta-agonists. (Consensus-Based)
1. Third-Line Drug Therapy for Patients with Persistent Asthma
  1. The addition of recombinant humanized monoclonal anti-IgE immunoglobulin is recommended for patients who:
    - Meet the criteria of the Kaiser Permanente guidelines for the use of omalizumab (Xolair)
      and
    - Have had a least one exacerbation resulting in a hospitalization or emergency department visit, or
    - Have had two or more exacerbations requiring systemic corticosteroids in the past 12 months, despite being on high-dose ICS and LABA. (Evidence-Based: A)
  1. There is at present insufficient evidence to support the addition of theophylline, cromolyn sodium, nedocromil, adrenergic beta-agonists, cyclosporine, anti-tumor necrosis factor, ipratropium, or IV immunoglobulin (IVIG) for patients whose persistent asthma is chronically uncontrolled on combination therapy plus rescue medication (Refer to" Assessing Asthma Control in Patients with Asthma" below). (Evidence-Based: I)
  2. It is recommended that patients requiring third-line medication therapy be referred for specialty care. (Consensus-Based)

Assessing Asthma Control in Patients with Asthma
1. Asthma Control
  1. The Asthma Control Test (ACT), Asthma Control Questionnaire (ACQ), and Asthma Therapy Assessment Questionnaire (ATAQ) are all options for validated questionnaires for the assessment of asthma control. (Evidence-Based: B)
  2. It is recommended that the ACT be used to assess the control of asthma. (Consensus-Based)
1. Risk of Future Exacerbations
  1. History of previous asthma exacerbations is a risk factor for future asthma exacerbations and should be elicited. (Evidence-Based: B)
  2. Evaluation of forced expiratory volume in one second (FEV₁) is recommended to assess risk for future asthma exacerbations. (Evidence-Based: B)
1. Risk of Decline in Lung Function
  Evaluation of asthma history (duration and severity of asthma), low FEV₁ or FEV₁/forced vital capacity (FEV₁/FVC) in childhood, smoking, lack of using ICS, atopy, and airway hyperresponsiveness may be used to assess risk for future decline in lung function. (Evidence-Based: B)
1. Complicating Factors and Concomitant Disease in the Assessment of Asthma
  Clinicians should evaluate a patient for comorbid conditions or alternative diagnosis when asthma is not well controlled. Such conditions include but are not limited to:
  - Gastroesophageal reflux disease
  - Vocal cord dysfunction
  - Allergic bronchopulmonary aspergillosis
  - Obesity
  - Obstructive sleep disorder
  - Rhinitis/sinusitis
  - Alpha-1 antitrypsin deficiency
  - Chronic obstructive pulmonary disease (COPD)
  - Smoking
  - Panic
  - Anxiety
  - Depression
  (Consensus-Based)

Treatment of Acute Exacerbations to First-Line for Mild to Moderate Exacerbations
1. Initial Treatment for Acute Exacerbation in an Acute Care Setting
  1. Racemic albuterol is recommended for people who present with a mild to moderate (peak expiratory flow rate [PEF] and/or FEV₁ ≥50% predicted and/or oxygen saturation ≥92% on room air) acute asthma exacerbation. The recommended dose is 2.5 to 5 mg by nebulizer every 20 minutes, repeated up to three times in one hour, or by metered dose inhaler (MDI) with spacer at four puffs every 20 minutes up to three times. (Evidence-Based: B)
  2. Levalbuterol offers no advantage in terms of improved efficacy or safety over albuterol in the treatment of acute exacerbations. (Evidence-Based: B)
1. Treatment of Severe Exacerbations (PEF or FEV₁ <50% Predicted on Entry) or Refractory to First-Line Therapy
  
  1. For the treatment of severe asthma exacerbations refractory to albuterol alone, or in patients presenting with a FEV₁ or PEFR <50% predicted, ipratropium bromide added to inhaled short-acting beta-agonist therapy is recommended. (Evidence-Based: B)
  
  2. Early intervention with corticosteroids is recommended in this population. (Evidence-Based: B)
  
  3. Oral or parenteral corticosteroids have been shown to be equally effective options. (Evidence-Based: C)
  
  4a. Inhaled heliox is not recommended as second-line therapy in the treatment of acute exacerbations of asthma. (Evidence-Based: D)
  
  4b. Inhaled heliox is an option in patients who are not responding to any of the above therapy and in an effort to avoid intubation. (Consensus-Based)
  
  5a. Intravenous magnesium sulfate is not recommended as second-line therapy in the treatment of acute asthma exacerbations. (Evidence-Based: D)
  
  5b. Intravenous magnesium sulfate is an option in patients who are not responding to any of the above therapy and in an effort to avoid intubation. (Consensus-Based)
1. Discharge After Treatment of Acute Exacerbation
  1. After discharge for an acute exacerbation of asthma, options for treatment are:
    - Oral corticosteroid (if an oral corticosteroid is used for less than 14 days, a taper is not needed)
    - Intramuscular depot methylprednisolone, 160 mg
    - High-dose inhaled corticosteroid; or
    - High-dose inhaled corticosteroid and oral corticosteroid (inhaled corticosteroid for three weeks at 1600 mcg per day budesonide or equivalent, and 50 mg per day oral prednisone for seven days). (Evidence-Based: C)
  1. Oral prednisone at the dose range 40 to 60 mg/day (or equivalent) is recommended. (Consensus-Based)
  2. Intramuscular corticosteroid is an option for patients with a history of non-adherence. (Consensus-Based)
  3. High-dose inhaled corticosteroid (dose range 1600 mcg to 3200 mcg per day budesonide or equivalent) is option for patients with a history of severe reactions to oral or intramuscular corticosteroid. (Consensus-Based)
  4. Maintenance dosing of inhaled corticosteroid should be continued or initiated after treatment of acute exacerbation. (Consensus-Based)

Adult Asthma Self-Management Program
1. Elements and Content of an Adult Asthma Self-Management Program
  1. Self-management patient education, appropriate to severity and individual understanding, should be provided to all patients with asthma.
    Individualized self-management patient education should be interactive and include at a minimum:
    - Self-monitoring of either symptoms or peak flow (including journals, workbooks, etc.)
    - Regular medical practitioner review
    - A written action plan based on monitoring results (either peak flow or symptom-based)
    - Action plan should provide for self-adjustment of medications based on monitoring results
    (Evidence-Based: B)
  1. A shared decision-making approach should be used to decide whether the patient should monitor using either a peak flow meter or by symptoms. For patients who may be poor perceivers of symptoms, peak flow-based self-management is recommended. For patients with a history of non-adherence, a symptom-based plan is recommended. (Consensus-Based)
  2. For patients at home whose asthma control starts to deteriorate (based on symptoms and/or peak flow, i.e., dropping to yellow zone), doubling the ICS dose is not recommended. (Evidence-Based: D)
  3. For patients at home whose asthma control starts to deteriorate (based on symptoms and/or peak flow, i.e., dropping to yellow zone), quadrupling the ICS dose or taking oral corticosteroids is an option. (Consensus-Based)
1. Best Methods for Achieving Adherence in Patients with Persistent Asthma
  1. Interactive training and education (see guideline on Adult Asthma Self-Management Program), including telephonic case management, that teaches basic skills, simplifies the regimen, and provides reinforcement is recommended for achieving adherence in patients with asthma. (Evidence-Based: B)
  2. Diagnosis and asthma treatment should be approached with the awareness that asthma severity, ethnicity, culture, English language proficiency, age, and socioeconomic considerations may affect patients' self-efficacy and perception of the condition, which in turn may be directly correlated with adherence to a specific course of treatment. (Consensus-Based)
  3. Approaching adherence to asthma drug therapy should include:
    - Assessment of patient's understanding of the condition
    - Screening assessment for depression
    - Identification of self-efficacy (confidence)
    - Assessment of cultural health beliefs and health behaviors regarding asthma or disease management in general
    - Oral and written communication in patient's primary language of preference
    - Explanation of the rationale behind maintenance therapy
    - Assessment and acknowledgment of patient preference to one type of delivery device (or one versus two devices) over another, especially with regard to controller therapy
    - Shared decision-making between the patient and provider is recommended to achieve patient adherence.
    (Consensus-Based)

Immunotherapy for Persistent Asthma
Specific immunotherapy is an option in patients with a significant allergic component (clear evidence of the relationship between symptoms and exposure to an allergen) to their asthma. (Consensus-Based)

Drug Therapy for Adult Patients with Exercise-Induced Asthma
1. For exercise-induced asthma, start therapy with a short-acting beta-agonist (such as albuterol) prior to exercise. (Evidence-Based: A)
2. An inhaled short-acting beta-agonist is recommended 5 to 15 minutes prior to exercise. (Consensus-Based)
3. For those patients where pretreatment with an inhaled short-acting beta-agonist (5 to 15 minutes prior to exercise) does not adequately prevent symptoms, check inhaler technique, assess to ensure that any persistent asthma is being treated adequately with inhaled corticosteroids, and verify the initial diagnosis. (Consensus-Based)
4. Treatment with montelukast, cromolyn sodium, or nedocromil, ipratropium bromide, or intermittent use of inhaled long-acting beta-agonists are options for patients who do not tolerate short-acting beta-agonist or for whom short-acting beta-agonist is ineffective. (Consensus-Based)

Drug Therapy for Pregnant Women with Asthma
1. Maintenance Therapy for Pregnant Women with Asthma
  1. Pregnant women with asthma should be treated the same as non-pregnant asthmatics except for the following specifications:
    - Budesonide is the preferred inhaled corticosteroid (the only category B corticosteroid)
      (Note: Drugs assigned a category B rating are not likely to pose a threat to the fetus from the evidence in animal studies, but no well-controlled studies have been performed in pregnant women. However, a drug may also receive a category B rating if animal studies have shown evidence of fetus damage but the same drug tested on pregnant women showed no increased risk, which was the case for budesonide.)
    - If there is concern about losing asthma control by switching inhaled corticosteroids and a patient's asthma is already well controlled on a different inhaled corticosteroid, there is no need to change to budesonide.
    - Albuterol is the preferred short-acting beta-agonist.
  1. There is little experience with leukotriene modifiers in pregnancy. Of these, zileuton is not recommended for use in pregnancy; and zafirlukast and montelukast should only be used for otherwise recalcitrant asthma that has responded to these medications prior to pregnancy. (Consensus-Based)
1. Therapy for Pregnant Women with Asthma After an Acute Exacerbation
  For pregnant women discharged after hospitalization for an acute exacerbation of their asthma, an inhaled corticosteroid, as needed inhaled short-acting beta-agonist, and an oral corticosteroid are recommended. (Consensus-Based)
  
  (Note: For management of an acute asthma exacerbation, see guideline on acute exacerbations in adults.)

Definitions:

Recommendations are classified as either "evidence-based (A-D, I)" or "consensus-based."

Evidence-based: Sufficient number of high-quality studies from which to draw a conclusion, and the recommended practice is consistent with the findings of the evidence. A recommendation can also be considered "evidence-based" if there is insufficient evidence and no practice is recommended.
Consensus-based: Insufficient evidence and a practice is recommended based on the consensus or expert opinion of the Guideline Development Team (GDT).

Label and Language of Recommendations*

Label	Evidence-Based Recommendations
Evidence-Based (A)	Language: ^a The intervention is strongly recommended for eligible patients. Evidence: The intervention improves important health outcomes, based on good evidence, and the Guideline Development Team concludes that the benefits substantially outweigh the harms and costs. Evidence Grade: Good.
Evidence-Based (B)	Language: ^a The intervention is recommended for eligible patients. Evidence: The intervention improves important health outcomes, based on 1) good evidence that benefits outweigh harms and costs; or 2) fair evidence that benefits substantially outweigh harms and costs. Evidence Grade: Good or Fair.
Evidence-Based (C)	Language: ^a No recommendation for or against routine provision of the intervention. (At the discretion of the Guideline Development Team, the recommendation may use the language "option," but must list all the equivalent options.) Evidence: Evidence is sufficient to determine the benefits, harms, and costs of an intervention, and there is at least fair evidence that the intervention improves important health outcomes. But the Guideline Development Team concludes that the balance of the benefits, harms, and costs is too close to justify a general recommendation. Evidence Grade: Good or Fair.
Evidence-Based (D)	Language: ^a Recommendation against routinely providing the intervention to eligible patients. Evidence: The Guideline Development Team found at least fair evidence that the intervention is ineffective, or that harms or costs outweigh benefits. Evidence Grade: Good or Fair.
Evidence-Based (I)	Language: ^a The evidence is insufficient to recommend for or against routinely providing the intervention. (At the discretion of the Guideline Development Team, the recommendation may use the language "option," but must list all the equivalent options.) Evidence: Evidence that the intervention is effective is lacking, of poor quality, or conflicting and the balance of benefits, harms, and costs cannot be determined. Evidence Grade: Insufficient.
Consensus-Based	Language: ^a The language of the recommendation is at the discretion of the Guideline Development Team, subject to approval by the National Guideline Directors. Evidence: The level of evidence is assumed to be "Insufficient" unless otherwise stated. However, do not use the A, B, C, D, or I labels, which are intended only to be used for evidence-based recommendations. Evidence Grade: Insufficient, unless otherwise stated.
For the rare consensus-based recommendations that have "Good" or "Fair" evidence, the evidence must support a different recommendation, because if the evidence were good or fair, the recommendation would usually be evidence-based. In this kind of consensus-based recommendation, the evidence grade should point this out (e.g., "Evidence Grade: Good, supporting a different recommendation.")

^[a]All statements specify the population for which the recommendation is intended.

^*Recommendations should be labeled and given an evidence grade. The evidence grade should appear in the rationale. Evidence is graded with respect to the degree it supports the specific clinical recommendation. For example, there may be good evidence that Drugs 1 and 2 are effective for Condition A, but no evidence that Drug 1 is more effective than Drug 2. If the recommendation is to use either Drug 1 or 2, the evidence is good. If the recommendation is to use Drug 1 in preference to Drug 2, the evidence is insufficient.

Complete Summary

GUIDELINE TITLE

BIBLIOGRAPHIC SOURCE(S)

GUIDELINE STATUS

COMPLETE SUMMARY CONTENT

DISEASE/CONDITION(S)

GUIDELINE CATEGORY

CLINICAL SPECIALTY

INTENDED USERS

GUIDELINE OBJECTIVE(S)

TARGET POPULATION

INTERVENTIONS AND PRACTICES CONSIDERED

MAJOR OUTCOMES CONSIDERED

METHODS USED TO COLLECT/SELECT EVIDENCE

DESCRIPTION OF METHODS USED TO COLLECT/SELECT THE EVIDENCE

NUMBER OF SOURCE DOCUMENTS

METHODS USED TO ASSESS THE QUALITY AND STRENGTH OF THE EVIDENCE

RATING SCHEME FOR THE STRENGTH OF THE EVIDENCE

METHODS USED TO ANALYZE THE EVIDENCE

DESCRIPTION OF THE METHODS USED TO ANALYZE THE EVIDENCE

METHODS USED TO FORMULATE THE RECOMMENDATIONS

DESCRIPTION OF METHODS USED TO FORMULATE THE RECOMMENDATIONS

RATING SCHEME FOR THE STRENGTH OF THE RECOMMENDATIONS

COST ANALYSIS

METHOD OF GUIDELINE VALIDATION

DESCRIPTION OF METHOD OF GUIDELINE VALIDATION

MAJOR RECOMMENDATIONS

CLINICAL ALGORITHM(S)

TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

POTENTIAL BENEFITS

POTENTIAL HARMS

QUALIFYING STATEMENTS

DESCRIPTION OF IMPLEMENTATION STRATEGY

IMPLEMENTATION TOOLS

IOM CARE NEED

IOM DOMAIN

BIBLIOGRAPHIC SOURCE(S)

ADAPTATION

DATE RELEASED

GUIDELINE DEVELOPER(S)

SOURCE(S) OF FUNDING

GUIDELINE COMMITTEE

COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

GUIDELINE STATUS

GUIDELINE AVAILABILITY

AVAILABILITY OF COMPANION DOCUMENTS

PATIENT RESOURCES

NGC STATUS

COPYRIGHT STATEMENT

NGC DISCLAIMER

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