Cough Variant Asthma: Montelukast With or Without Budesonide and Formoterol

By Patrick Daly - October 25, 2022

In a randomized controlled trial published in Respiratory Research, researchers compared cysteinyl-leukotriene receptor antagonists (LTRAs) and inhaled corticosteroids plus long-acting β2-agonist (ICS/LABA) using montelukast and budesonide/formoterol, respectively, in patients with cough variant asthma.

According to the study’s authors, montelukast alone had similar efficacy as budesonide/formoterol alone for reducing cough reflex sensitivity and eosinophilic airway inflammation, and the combination of both treatments yielded additional lung function improvements and alleviated peripheral eosinophils.

The study included 99 patients with cough variant asthma who were randomized 1:1:1 to 8 weeks of treatment with montelukast 10 mg once daily, budesonide/formoterol 160/4.5 μg inhaled twice daily, or montelukast plus budesonide/formoterol. The primary end points of the study were cough visual analogue scale (VAS) score, daytime cough symptom score (CSS), and nighttime CSS. Additional end points included cough reflex sensitivity, percentage of sputum eosinophils, and fractional exhaled nitric oxide.

Cough Variant Asthma Treatment With LTRA Versus ICS Plus LABA

The researchers reported that median cough VAS score significantly decreased from:

  • 6.0 to 2.0 in the montelukast group
  • 5.0 to 1.0 in the budesonide/formoterol group
  • 6.0 to 1.0 in the combination group (P<.01)

Additionally, daytime CSS and nighttime CSS significantly decreased in all three groups, the authors wrote. Furthermore, cough reflex sensitivity—defined as the lowest concentration of capsaicin that induced 5 coughs—and percentage of sputum eosinophils significantly improved for all three groups after 8 weeks (P<.05). Notably, no significant differences were observed among changes in VAS score, daytime and nighttime CSS, cough reflex sensitivity, and percentage of sputum eosinophils from baseline to week 8 between the three groups (P>.05).

Patients in the budesonide/formoterol (P=.001) and combination groups (P=.008) also had significant decreases in fractional exhaled nitric oxide, while patients in the montelukast group did not show any significant change (P=.457). The authors noted that the combination regimen also significantly improved forced expiratory volume in 1 second to forced vital capacity ratio, predicted maximal mid-expiratory flow, and percentage of blood eosinophils (P<.05).

Overall, the authors suggested that montelukast was comparable with budesonide/formoterol alone and when combined, and that it could be an effective alternative treatment option for patients with cough variant asthma.”Whether the combination treatment plays a role in the long-term prognosis of CVA needs to be further investigated,” the authors closed.

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