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The Asthma Control Test (ACT)i is a standardized and validated questionnaire that examines 5 aspects of the impact that asthma has on the patient: (1) effect on activities, work, school; (2) amount of shortness of breath; (3) nocturnal awakening with asthma; (4) use of rescue inhaler; and (5) overall asthma control. Each question can be scored by the patient on a 1-5 scale so that the worst score is 5 and the best score is 25. A score of 19 or less has been established to indicate less than optimal asthma control. This questionnaire can be filled out by the patient while waiting, and gives the care-giver a quick idea of the overall control of the asthma (like the measurement of the BP in a hypertensive patient).

The ACT is useful tool when assessing asthma control and guiding treatment. In patients that have perfect or almost perfect scores on repeated visits, attention can be given to stepping therapy down to a lower intensity. Patients with low scores should be evaluated to determine that asthma is the cause of the low score and then adjustments upward in treatment intensity should be made.

OUR CASE:

A 39 year old African-American female presents to her primary care physician because of wheezing and shortness of breath. The patient had asthma as a child. Her asthma went into remission during her teenage years, but became active again when she was 32 years old. Since that time, she has had problems with daily wheezing, chest tightness, and shortness of breath. The symptoms awaken her from sleep most nights and she has days were she cannot work because of her symptoms. She has had to go to the Emergency Department (ED) three times in the last year because of severe episodes of shortness of breath and required a short burst of oral corticosteroids each time. She uses an albuterol inhaler several times daily and had been given beclomethasone 40 mcg/puff MDI 2 puffs BID that she uses irregularly. While in the waiting area, she filled out the Asthma Control Test (ACT) and her score was 12.

History and Physical:

 

This patient has a history of hypertension that has been treated with hydrochlorothiazide. She reports that she has always been “chunky” but has gained more weight over the last few years. She currently is 230 lbs and has a body mass index of 38.3. She has no history of alcohol, drugs, or tobacco use. A high school graduate, she lives in an inner city apartment in Atlanta with her teenage daughter. They have no pets. She is employed with health insurance currently, but has been unemployed most of the last three years. Her mother had asthma, but her daughter has not exhibited any breathing difficulties.

She has no history of allergies or symptoms of gastroesphogeal reflux disease and does not report snoring or day time somnolence. Her physical examination revealed a blood pressure of 135/85 mmHg, pulse 82 bpm, and regular, respiratory rate of 21, Temp 37.6 C, and her room air O2 saturation is 93%. Her nasal mucosa appears normal, and there is no sinus tenderness. Her posterior pharynx is normal. There is no stridor, neck vein distention, thyromegaly, or tracheal deviation.

Auscultation of her chest reveals scattered wheezes, but no rales, rhonchi, or pleural rubs. Her heart sounds are normal for S1 and S2. Palpitation of her abdomen is negative for organomegaly, or tenderness. She does not appear to have any clubbing of her digits, edema, or cyanosis. A chest radiograph was done during her last ED visit and showed only hyperinflation and no adenopathy or infiltrates. Her laboratory and PFT results are listed below.

Laboratory Pulmonary Function Studies
IgE – 150 U/ml
Total eosinophil count – 400 cells/microliter
FVC – 92% predicted
FEV1 – 62% predicted
FEV1/FVC ratio – 65%
A 15% improvement in the FEV1 occurred after a post bronchodilator study with albuterol

How would you classify this patient’s asthma control?

a) Well controlled
b) Moderately controlled
c) Controlled
d) Poorly controlled
e) Very poorly controlled
 

Discussion:

 

Based on the NHLBI Expert Panel Report 3iii,, the patient has “very poorly controlled” asthma. The guidelines suggest that the patient should be treated at Step 3, where the preferred treatment is low dose inhaled corticosteroid (ICS) and long-acting beta agonist (LABA). The alternative treatment is medium-dose ICS, however, multiple randomized controlled trials and meta-analyses have established that low dose ICS combined with LABA is more effective than medium dose ICS. iii, iv, v

Our Case Continued:

 

The patient was started on a combination inhaler containing fluticasone 100ug/salmeterol 50ug DPI per inhalation taken twice a day, and was instructed on the use of the discus inhaler, and her metered dose albuterol inhaler, and the importance of daily use of the controller medication. Education on asthma and the treatment of asthma were given and a return visit was scheduled for 6 weeks. She was also started on a weight loss program, but her progress was slow.

At the return visit, the patient’s ACT was now 22 and she was feeling much improved. She noted within a day or two of starting the new inhaler that she needed less albuterol and she was no longer awakening at night with symptoms. Her repeat spirometry was now normal. The regimen of ICS+LABA was continued and the patient was reminded to continue her controller medication twice a day, no matter how well she felt. She was referred for allergy skin testing to facilitate avoidance therapy and was appointed to return in 3 months.

Are long-acting beta agonists contraindicated in the treatment of African-American asthma patients?

a) Yes
b) No
c) Neither Yes or No
 

Discussion:

 

This question has been controversial since the publication of the Salmeterol Multicenter Asthma Research Trial (“SMART”) in 2006vi. In that trial, asthma patients were randomized to receive salmeterol vs. placebo. No attempt to control other asthma medications was performed. The outcome of the trial was (1) a small increase in respiratory-related and asthma-related deaths and life-threatening experiences in the total population receiving salmeterol, and (2) the risk for these adverse outcomes appeared to be greater in African-Americans. A subsequent meta-analysis that was dominated by the data from the SMART trial found the same conclusions.vii

On further examination of the SMART data, the possible reasons for the adverse outcomes become clear. Less than half of the patients in both the placebo group and the salmeterol group reported the use of ICS. In the subgroup of African-American patients, an even smaller percentage was using ICS. The data also suggested that the African-American patients had more severe asthma at the beginning of the trial.

Use of any continuous beta agonist therapy, whether short-acting or long-acting, without ICS has been known since the 1970s to be associated with adverse outcomes. The treatment guidelines all require that the first step in treatment of asthma is regular use of ICS.

A recently published meta-analysis has established that LABA added to ICS is not associated with adverse outcomes.viii A randomized controlled trial of addition of LABA to ICS versus ICS alone in African-American asthma patients found no increase in adverse events and an improvement in asthma control markers during one year of treatment.ix Recent review articles on the addition of long-acting beta-agonists to inhaled corticosteroids and on the treatment of asthma have confirmed this approach.x, xi So that the LABA is always taken with the ICS, this should be prescribed as a fixed dose combination inhaler.

Does obesity play a role in the incidence and severity of asthma?

a) Yes
b) No
 

Discussion:

 

In the last several years, it has been noted that obesity increases both the prevalence and incidence of asthma. Additionally, obesity plays a role in asthma severity and control and may alter the effects of asthma medications.xii

The mechanisms for this relationship are being actively studied. Potential mechanisms include shared genetic predisposition, co-morbidities that worsen asthma (sleep disordered breathingxiii, GERD, etc), effects of obesity on lung mechanics (reduced lung volumes produces increased airways resistance), and effects on airway inflammation and hyperreactivity resulting from the pro-inflammatory state associated with obesity. A mouse model of obesity associated with increased airway reactivity has been established and is playing a role in clarifying these relationships.xii

Does weight loss in obese patients improve asthma control? A recently published systematic analysis of 15 studies that examined both medical and surgical treatments for obesity found that there was an improvement in at least one asthma outcome after weight loss.xiv

Is there evidence that race, socio-economic status, gender, and living situation play a role in the prevalence and severity of asthma?

a) Yes
b) No
 

Discussion:

 

Data has shown that there has been a 12.3% increase in the prevalence of asthma from 2001-2009 and the increase has been most prominent in the young, minorities, women, and the poor. Additionally, low income groups, minorities, and children have higher rates of hospitalization, ED visits, and mortality compared to the general population.xv

Patients with asthma who live in urban, inner city settings have greater exposure to air born pollution and indoor allergens such as cockroach, mold, and dust mites. These living situation factors may increase asthma severity.xv

What is the next treatment step in this patient?

a) Omalizumab injected once a month
b) Double the daily dose of inhaled steroids
c) Add a long-acting beta agonist twice a day
d) Add a leukotriene modifier daily
e) Start daily oral steroids
 

Conclusion:

 

The patient was started on the long-acting beta agonist fluticasone 100ug/salmeterol 50ug DPI per inhalation taken twice a day, and was instructed on the use of the discus inhaler, and her metered dose albuterol inhaler (new prescription provided), and the importance of daily use of the controller medication. Education on asthma and the treatment of asthma were given and a return visit was scheduled for 6 weeks.

 

i   Nathan RA, Sorkness CA, Kosinski M, et al. Development of the asthma control test: a survey for assessing asthma control. J Allergy Clin Immunol. 2004;113:59-65.

ii   National Asthma Education and Prevention Program. Expert Panel Report 3: Guidelines for the Diagnosis and Management of Asthma. National Institutes of Health, National Heart, Lung, and Blood Institute, August 2007. NIH Publication 08-4051. Available: http://www.nhlbi.nih.gov/guidelines/asthma/asthgdln.pdf Accessed 12/27/2011

iii   Ducharme FM, Ni Chroinin M, Greenstone I, et al. Addition of long-acting beta2-agonists to inhaled corticosteroids versus same dose inhaled corticosteroids for chronic asthma in adults and children. Cochrane Database of Systematic Reviews 2010, Issue 5. Art. No.: CD005535. DOI: 10.1002/14651858.CD005535.pub2.

iv   Woolcock A, Lundback B, Ringdal N, et al. Comparison of addition of salmeterol to inhaled steroids with doubling of the dose of inhaled steroids. Am J Respir Crit Care Med. 1996;153:1481-1488.

V   Pauwels RA, Löfdahl C-G, Postma DS, et al. Effect of inhaled formoterol and budesonide on exacerbations of asthma. N Engl J Med. 1997;337:1405-1411. [Erratum, N Engl J Med. 1998;338:139.]

vi   Nelson HS, Weiss ST, Bleecker ER, et al. The salmeterol multicenter asthma research trial: A comparison of usual pharmacotherapy for asthma or usual pharmacotherapy plus salmeterol. Chest. 2006;129:15-26.

vii   Salpeter SR, Buckley NS, Ormiston TM, et al. Meta-analysis: Effect of long-acting B-agonists on severe asthma exacerbations and asthma-related deaths. Ann Intern Med. 2006;144:904-912.

viii   Bateman E, Nelson H, Bousquet J, et al. Meta-analysis: Effects of adding salmeterol to inhaled corticosteroids on serious asthma-related events. Ann Intern Med. 2008;149:33-42.

ix   Bailey W, Castro M, Matz J, et al. Asthma exacerbations in African Americans treated for one year with combination fluticasone propionate and salmeterol or fluticasone propionate alone. Curr Med Res Opin. 2008;24:1669-1682.

x   Sears MR. The addition of long-acting beta-agonists to inhaled corticosteroids in asthma. Curr Opin Pulm Med. 2011;17:23-28.

xi   Fanta CH. Drug therapy: Asthma. N Engl J Med. 2009;360:1002-1014.

xii   Dixon AE, Holguin F, Sood A, et al. An official American Thoracic Society workshop report: Obesity and asthma. Proc Am Thorac Soc. 2010:7;325-335.

xiii   Alkhalil M, Schulman E, Getsy J. Obstructive sleep apnea syndrome and asthma: What are the links? J Clin Sleep Med. 2009;5:71-78.

xiv   Eneli IU, Skybo T, Camargo CA. Weight loss and asthma: A systematic review. Thorax. 2008; 63:671-676.

xv   Graham LM, Staton GW. Disparities in Asthma: Who’s at Risk. ACCP Inner-City Respiratory Alliance Professional Education Center. 2011. Available at: http://www.notonemorelife.org/coursereview.aspx?url=2200%2fPDF%2fOP0001_fnl1.pdf&scid=14656

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