“Severe-controlled” asthma 4 years later: is it still controlled?

Abstract

Background

Controlled severe asthma is based on needing regular medication and 4 markers of good asthma control. This study reevaluated a community sample defined 4 years earlier as “severe-controlled” based on electronic medical records of medications dispensed over 12 months.

Objectives

Determine the current extent of clinically-controlled asthma and asthma-related quality-of-life among patients previously considered “severe-controlled”.

Methods

69 patients considered “severe-controlled” 4 years earlier answered a questionnaire that included the asthma control test (ACT), demographics, education, comorbidities, medications, asthma-related healthcare utilization, atopy history, environmental exposures, and follow-up. Patients underwent spirometry, eosinophil count, total IgE, and skin–prick testing for airborne allergens.

Results

Ninety-seven percent reported using combined inhalers (ICS + LABA) regularly. Only 4% visited the ER and none was hospitalized in the last year. Average predicted FEV₁ was 80%. Average ACT score was 19; 51% reported recurrent heartburn, 46% night awakenings and 70% recurrent rhinitis. Skin–prick testing was positive in 72%, average IgE was 376 IU/ml. Eosinophil counts were ≥300/ml in 42% and ≥400/ml in 25%. ACT < 20 was strongly related to recurrent heartburn. Formal education was related to ACT ≥ 20 (p = 0.045) and perception of good asthma control the previous month (p < 0.001). Eosinophil count, recurrent heartburn, total IgE, and recurrent rhinitis were interrelated.

Conclusions

Among severe asthmatics, good drug compliance, low use of relievers and low rates of exacerbations do not necessarily reflect asthma-related quality-of-life and optimal control. We urge physicians and HMOs to address asthma control in terms of quality-of-life based on validated questionnaires, and offer all patients asthma education; perhaps more to those with low formal education.

Keywords:

• Severe asthma
• severe controlled asthma
• asthma control test (ACT)
• heartburn
• eosinophils
• total IgE
• subjective perception

Declaration of interest

Independent grant from Novartis.

Acknowledgements

The authors thank Gregori Kushner MD and Yaaqub Abu Khashab MD for assistance in outpatient clinic examinations, and Shai Shavit and Idan Ravid-Kahlberg for study coordination. We thank Nira Koren-Morag, PhD, Dept. of Epidemiology and Preventive Medicine, Sackler School of Medicine, Tel Aviv University for statistical analysis and Faye Schreiber, MS, Meir Medical Center, Kfar Saba, Israel for editing the manuscript.

Statement of ethics

Participants (or their parents or guardians) provided written informed consent. The study protocol was approved by the research institute’s ethics committee on human research (approval number: 032/2013 C). Clinical trial registration: NCT01961258.

Author contributions

S. Varsano: Study design and conception

S. Varsano, L. Israeli, N. Koren-Morag: Data acquisition and interpretation

S. Varsano, N. Koren-Morag: Data analysis and interpretation

All authors: Drafted and revised the submitted article

S. Varsano: Provided final approval of the version to be published

S. Varsano: Guarantor of manuscript

Additional information

Funding

This work was supported by a Novartis Investigator Initiated Trial (grant number CIGE025AIL09T). Novartis had no role in preparation of data or in preparation of this manuscript.