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Protocol Title: Adult Asthma Protocol

Effective Date: 4/27/2016 Version: 1.0

Approval By: CCC Clinical Delivery Steering Planned Review Date: 4/27/2017

1 Purpose & Objective This protocol provides evidence-based care recommendations in the screening and treatment of asthma in the

primary care setting. The protocol seeks to assist in early diagnosis and effective treatment of asthma. The

asthma protocol should provide primary care physicians, family nurse practitioners, and physician’s assistants

with a guide that is evidence-based and cost effective.

2 Scope of Protocol

2.1 Target Population

This protocol was derived from clinical guidelines for individuals in the CCC population diagnosed with

asthma who are 18 years of age or older.

2.2 Target Users

This protocol is developed for use in primary care settings. Family physicians, internists, primary care

physician assistants and nurse practitioners should use this protocol.

2.3 Excluded Topics

This protocol does not address the clinical management of adult patients with asthma exacerbation and

COPD.

2.4 Related Guidelines

U.S. Department of Health and Human Services, National Heart, Lung, and Blood Institute (2007).

Guidelines for the diagnosis and management of asthma. Retrieved from

http://www.nhlibi.nih.gov/guidelines/asthma

Nathan, R. A., Sorkness, C. A., Kosinski, M., Schatz, M., Li, J. T.,…Pendergraft, T. B. (2004). Development

of the asthma control test: A survey for assessing asthma control. Journal of Allergy and Clinical

Immunology, 113(1), 59-65. doi:10.1016/j.jaci.2003.09.008

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3 Protocol Development & Approval Process

This protocol originated in the CCC Clinical Protocol Subcommittee, led by a pulmonologist. A group of

clinical staff met and converged on the items in this document via a Rapid Design Session. In this session, a

clinical champion guided the group through the process to extract evidence-based elements to adequately care

for the CCC population impacted by asthma. The above depiction describes the approval and subsequent

review process for this protocol.

Group Name Approval Date

CCC Asthma Protocol Subcommittee 11/12/15

CCC Clinical Protocols Workgroup 11/12/15

CCC Clinical Delivery System Steering Group (11/2015; 12/2015; 2/2016) Approved: 4/27/2016

CCC Advisory Committee

CCC Board of Directors

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4 Screening Criteria & Risk Factors

4.1 Assessing Risk:

History:

Cough, worse at night

Recurrent:

Wheezing

Chest tightness, and

Shortness of breath

Symptoms are:

Seasonal

Worse with infections and exposures

Worse late at night or early in morning

Co-morbitities:

Diagnosis and modify treatment based on co-morbidities:

Allergies

Eczema

Hay fever

Sleep apnea

Acid reflux

Obesity

Family history of asthma

Allergies

History of smoking

5 Screening Tests: Asthma Control Test (ACT)

The Asthma Control Test should be administered at every visit

A five question validated tool to assess asthma control that is self-administered by the patient

Clinically validated (Nathan, R. A., Sorkness, C. A., Kosinski, M., Schatz, M., Li, J.

T.,…Pendergraft, T. B. (2004). Development of the asthma control test: A survey for assessing

asthma control. Journal of Allergy and Clinical Immunology, 113(1), 59-65.

doi:10.1016/j.jaci.2003.09.008)

Responses: Measured on a 1-5 Likert Scale where lower scores equate to lower control

A score of 19 or less indicates the patients asthma many not be as controlled as is possible

See Appendix A: Asthma Control Test

Spirometry

Peak flow/expiratory flow (best performance 80% or above)

Allergy testing if significant history of allergies:

Determination of sensitivity to a perennial indoor allergen

Allergy skin or in vitro testing

Test only for sensitivity to the allergens to which the patient may be exposed

Order “Allergy Panel 10” available in NextGen

Most common allergens:

o House-dust mites

o Pollens

o Molds

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o Cat or dog (Animal dander)

o Both cat and dog

o Cockroaches (inner-city and southern United States)

6 Criteria for Diagnosis of

6.1

A. History

Clinical characteristics of asthma

o Symptoms

o Airway obstruction

o Inflammation

o Hyper-responsiveness

History of any of the following:

o Cough, worse at night

o Recurrent wheeze

o Recurrent difficulty in breathing

o Recurrent chest tightness

B. Spirometry with obstruction

Spirometry measurements:

FEV1 forced expiratory volume in 6-seconds (FEV6), FEV, FEV1/FVC before and after the

patient inhales a short-acting bronchodilator should be undertaken for patients in whom the

diagnosis of asthma is being considered

C. Response to asthma treatment

7 History and Assessment of Severity and Management The functions of assessment and monitoring are based on the concepts of severity, control, and

responsiveness to treatment:

Severity: intrinsic intensity of the disease process

Control: degree to which the manifestations of asthma (symptoms, functional impairments, and risk

of untoward events) are minimized and the goals of therapy are met

Responsiveness: the ease with which asthma control is achieved by therapy

Severity and control include the domains of current impairment and future risk:

Impairment: frequency and intensity of symptoms and functional limitations the patient is

experiencing or has recently experienced

Risk: likelihood of either asthma exacerbation, progressive decline in lung function or risk of adverse

effects from medication

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(NHLBI Guidelines for the Diagnosis and Treatment of Asthma Expert Panel Report 3, 2007)

1. Initial visit

a. Diagnosis of asthma

b. Give the asthma action plan (Paste link here) (English and Spanish)

c. Provide asthma education (initial and follow-up visits)

d. Lifestyle changes and modification of exposures (education on initial and follow-up)

e. Identify and address co-morbid conditions

f. Assessment of side effects of medications

g. Vaccinations

2. Subsequent visits

a. Asthma control (See above) (Decision to step up and/or step down)

b. Ensure use of inhaler correctly (use of spacer initial and follow-up)

c. Education

d. Asthma action plan (reinforce)

e. Spirometry every 1-2 years depending on symptoms (repeating) (if they are well controlled you

may not need to repeat)

f. Subsequent visits every 2-6 weeks until asthma controlled and then every 1-6 months

a. When initiating therapy, monitor at 2-6 week intervals to ensure that asthma control is

achieved

b. Regular follow-up contacts at 1-6 month intervals (based on level of control) are

recommended to ensure that control is maintained

g. Co-morbid conditions (continue to address)

a. Assessment of side effects of medications

b. Vaccinations

a. Influenza vaccination

b. Pneumococcal vaccination

3. Asthma Action Plan

a. Appendix A: Asthma Action Plan

i. U.S. Department of Health and Human Services, National Heart Lung and Blood

Institute. (2007). Asthma action plan. NIH Asthma Action Plan

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8 Goals of Therapy Reduction in impairment:

Prevent chronic and troublesome symptoms

Require infrequent use (< 2 days/week) of inhaled short-acting beta2 agonist (SABA) for rapid relief

of symptoms (excluding prevention of exercise-induced bronchospasm (EIB))

Maintain (near) normal pulmonary function (Asthma Control Test score of 20 or >)

Maintain normal activity levels (exercise and attendance at work or school)

Meet patients’ and families’ expectations of satisfaction with asthma care

Reduction in risk:

Prevent recurrent exacerbations of asthma and minimize the need for Emergency department (ED)

visits and/or hospitalizations

Prevent progressive loss of lung function

Provide optimal pharmachotherapy with minimal or no adverse effects

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9 Medication Table

SD – Starting Dose/LD – Low Dose/MD – Medium Dose/HD – High Dose

Class Medication Dosages (Refer to Key Below) Pharmacy

Leukotriene Modifiers

Singulair (Montelukast) 10 mg/qHS Retail

Zyflo (Zileuton) 600 mg/ QID PAP

Respiratory Smooth Muscle Relaxants

Theophylline ER SD-10 mg/kg/day up to 300mg maximum Max Dose-[Usual] 800 mg/day

Retail

Inhaled Corticosteroids

QVAR MDI (Beclomethasone Dipropionate)

LD-80 mcg/1 puffs BID MD-80 mcg/2 to 3 puffs BID HD-80 mcg/4 puffs BID

Retail

Asmanex Twisthaler DPI (Mometasone Furoate)

LD-220 mcg/1 puff daily MD-220 mcg/2 puffs daily HD-220 mcg/2 puffs BID

CENTRAL

Pulmicort Flexhaler DPI (Budesonide)

LD-180 mcg/1 puffs BID MD-180 mcg/2 to 3 puffs BID HD-180 mcg/4 puffs BID

CENTRAL

Flovent Diskus DPI (Fluticasone Propionate)

LD-100 mcg/1 puff BID MD-100 mcg/2 puffs BID OR 250 mcg/1 puff BID HD-250 mcg/2 puffs BID

PAP

Flovent HFA MDI (Fluticasone Propionate)

LD-110 mcg/1 puff BID MD-110 mcg/2 puffs BID OR 220 mcg/1 puff BID HD-110 mcg/4 puffs BID OR 220 mcg/2 puffs BID

PAP

Combinations Steroid/Long-acting B2

Agonist

Dulera MDI (Mometasone/ Formoterol)

LD-100 mcg/5 mcg/1 puff BID MD-100 mcg/5 mcg/2 puffs BID OR 200 mcg/5 mcg/1 puff BID HD-200 mcg/5 mcg/2 puffs BID

CENTRAL

Advair Diskus DPI (Fluticasone/Salmeterol)

LD-100 mcg/50 mcg/1 puff BID MD-250 mcg/50 mcg/1 puff BID HD-500 mcg/50 mcg/1 puff BID

PAP

Advair HFA MDI (Fluticasone/Salmeterol)

LD-45 mcg/21 mcg/2 puffs BID MD-115 mcg/21 mcg/2 puffs BID HD-230 mcg/21 mcg/2 puffs BID

PAP

Long-acting B2

Agonist Serevent Diskus DPI (Salmeterol)

50 mcg/1 puff BID PAP

Serevent HFA MDI (Salmeterol)

21 mcg/2 puffs BID PAP

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10 Medication Algorithm

*Theophylline is less desirable due to monitoring serum levels

*Theophylline is less desirable due to monitoring serum levels

*Theophylline is less desirable due to monitoring serum levels

Step 1: Intermittent asthma Preferred Treatment:

Inhaled SABA as needed

Step 2: Persistent asthma Preferred Treatment:

Daily Medication o Low-dose inhaled corticosteroid (ICS)

Alternative Treatment:

Cromolyn ,

Leukotriene receptor antagonist (LTRA) or

Theophylline*

Step 3: Persistent asthma Preferred Treatment:

Daily Medication o Medium-dose steroids o Low-dose ICS + LABA

Alternative Treatment:

Low-dose ICS + LTRA, Theophylline*, or Zileuton

Step 4: Persistent asthma Preferred Treatment:

Daily Medication o Medium-dose ICS + LABA

Alternative Treatment:

Medium-dose ICS + LTRA, Theophylline*, or Zileuton

Step 5: Persistent asthma Preferred Treatment:

Daily Medication o High-dose ICS + LABA AND consider

Omalizumab (Potential anaphylaxis)

Step 6: Persistent asthma Preferred Treatment:

Daily Medication o High-dose ICS + LABA+ Steroids AND

consider Omlizumab

Prior to oral corticosteroids a trial of High-dose ICS + LABA, Theophylline, or Zileuton may be considered (Not studied in clinical trials)

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10 Referrals

Referral to an Asthma Specialist for Consultation or Co-management

The Expert Panel recommends referral for consultation or care to a specialist in asthma care (usually, a

fellowship-trained allergist or pulmonologist; occasionally, other physicians who have expertise in asthma

management, developed through additional training and experience) when (Evidence D):

Patient has had a life-threatening asthma exacerbation.

Patient is not meeting the goals of asthma therapy after 3–6 months of treatment. An earlier referral or

consultation is appropriate if the physician concludes that the patient is unresponsive to therapy.

Signs and symptoms are atypical, or there are problems in differential diagnosis.

Other conditions complicate asthma or its diagnosis (e.g., sinusitis, nasal polyps, aspergillosis, severe

rhinitis, VCD, GERD, and COPD).

Additional diagnostic testing is indicated (e.g., allergy skin testing, rhinoscopy, complete pulmonary

function studies, provocative challenge, and bronchoscopy).

Patient requires additional education and guidance on complications of therapy, problems with

adherence, or allergen avoidance.

Patient is being considered for immunotherapy.

Patient requires step 4 care or higher. Consider referral if patient requires step 3 care.

Patient has required more than two bursts of oral corticosteroids in 1 year or has an exacerbation

requiring hospitalization.

Patient requires confirmation of a history that suggests that an occupational or environmental inhalant

or ingested substance is provoking or contributing to asthma. Depending on the complexities of

diagnosis, treatment, or the intervention required in the work environment, it may be appropriate in

some cases for the specialist to manage the patient over a period of time or to co-manage with the

PCP.

Community Health Paramedics (CHP):

o Educating patients in the field

o Reinforce training and education (peak flow will be important in the field)

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11 Special Situations Asthma in Pregnancy:

Headings 1-8 remain the same nothing changes. With ANY signs of changes refer early

Medications:

Budesonide is Cat B

Montelukast is Cat B

o Caveat: asthma control is more important than choice of medication as long as they are Cat B

or C

Check asthma control at all prenatal visits

Treating asthma with medications is safer for both mother and baby compared to poorly controlled

asthma

Inhaled corticosteroids are the treatment of choice

Patient education: Avoid exposure to tobacco smoke

12 Metrics

Reduce Impairment Outcome

o Prevent chronic symptoms

o Require infrequent use of short-acting

beta 2 – agonist (SABA)

o Maintain [near] normal lung function

and normal activity levels

Reduce Risk Outcome

o Prevent exacerbations

o Minimize need for ED care and/or

hospitalization

o Prevent loss of lung function

o Minimize adverse effects of therapy

Asthma Control Test Post (19 or >) Process

Asthma Education Outcome

o Self-monitoring to assess level of

control

o Taking medication correctly

o Inhaler use and technique

o Avoiding environmental factors that

worsen asthma

Outcome

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13 Protocol Development Team

Name Affiliation

Mark Hernandez, MD

*Chief Medical Officer

Hash Babbar, MD

*Clinical Champion

Claudia Ruiz, MD Peoples Community Clinic

Maaya Srinivasa, PharmD CommUnityCare

Andy Hofmeister, Commander Austin-Travis County EMS/ATCEMS Community Health

Paramedic Program

Joanne Scanlon, FNP CommUnityCare

Veronica Buitron-Camacho, MSN, RN CCC Program Manager

Curk McFall, MSN, RN CCC Director Integrated Delivery System Implementation

14 References U.S. Department of Health and Human Services, National Heart, Lung, and Blood Institute (2007).

Guidelines for the diagnosis and management of asthma. Retrieved from

http://www.nhlibi.nih.gov/guidelines/asthma

Nathan, R. A., Sorkness, C. A., Kosinski, M., Schatz, M., Li, J. T.,…Pendergraft, T. B. (2004). Development

of the asthma control test: A survey for assessing asthma control. Journal of Allergy and Clinical

Immunology, 113(1), 59-65. doi:10.1016/j.jaci.2003.09.008

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15 Glossary of Abbreviations

Abbreviation Term

ACT Asthma Control Test