Very Poorly Controlled Asthma Persists for More Than a Decade

June 6, 2016
Mark L. Fuerst
Mark L. Fuerst

Variables associated with very poorly controlled asthma identified by TENOR II study offer targets for more aggressive disease management.

Nearly half of patients with severe or difficult-to-treat asthma still have very poorly controlled (VPC) symptoms after more than a decade of treatment, according to a new study.

Asthma is considered well-controlled if:

 â–º Symptoms occur twice a week or less
 â–º Rescue bronchodilator medication is used twice a week or less
 â–º There is no nocturnal or early morning waking
 â–º There are no limitations on activities including work, school, and exercise
 â–º Patient and doctor consider the asthma well-controlled; and,  
 â–º The patient’s peak expiratory flow and forced expiratory volume in one second (FEV1) are normal.

The Epidemiology and Natural History of Asthma: Outcomes and Treatment Regimens (TENOR I) study assessed a large cohort of severe or difficult-to-treat asthma patients. The follow-up TENOR II study examined the prevalence of persistent VPC asthma more than 10 years after TENOR I. Patients’ asthma was classified as VPC based on the National Heart, Lung, and Blood Institute asthma guidelines.

TENOR II was a multicenter, observational study with a single follow-up visit in 2014 that included 341 patients; 327 patients had an available level of asthma control for both the TENOR I and II time points.

“Persistent VPC asthma was defined as having VPC asthma at both TENOR I and TENOR II enrollment visits; the comparison group had well or not well-controlled asthma at either visit,” said lead author Tmirah Haselkorn, PhD, of EpiMetrix in Los Altos, California.

Haselkorn presented the results of the study (Abstract 4843) on May 15, 2016 at the American Thoracic Society 2016 International Conference in San Francisco, CA.

Nearly half (48%) of patients had persistent VPC asthma. Higher levels of comorbidities were found among patients with persistent VPC compared to those with non-persistent VPC asthma, including gastroesophageal disease (52.2% versus 41.2%, respectively). Patients with persistent VPC also had lower lung function, and were more than three times as likely to require hospitalization/emergency department visits for exacerbations that required corticosteroids in the previous 12 months.

About one-quarter of the patients with persistent VPC asthma had not used a combined inhaled corticosteroid/long-acting beta2-agonist medication in the prior six months; only 12.7% had used omalizumab.

In multivariable analyses, five variables measured at TENOR I enrollment were significantly
predictive of persistent VPC asthma: Black race (versus White), current or past smoking status (versus never smoked), FEV1% predicted post-bronchodilator (per 10% decrease) and corticosteroid course for
worsening asthma in the prior 3 months.

Several demographic and clinical factors were predictive of persistent VPC outcome and their presence should direct more intensive management of modifiable factors. “Patients with persistent VPC asthma demonstrated higher disease burden, compromised lung function, and higher total and specific immunoglobin E levels than patients with non-persistent VPC asthma,” Haselkorn said.

Medication data suggested that patients may be undertreated. Findings also suggest that patients may not be compliant with prescribed therapy.

The researchers concluded that when asthma patients present with variables associated with a greater risk for VPC, clinicians should direct more intensive management of modifiable factors, such as smoking and lung function, as well as improved medication adherence or alternative treatment strategies.