Non-comparative, multicenter trial to assess the additional responses of Accolate (Zafirlukast) in persistent bronchial asthma

Park, J W; Cho, Y J; Yoon, H J; Park, H S; Choi, I S; Choi, B W; Park, C S; Min, K U; Rhee, Y K; Kim, N S; Hong, C S

Abstract

BACKGROUND AND OBJECTIVE: Accolate, one of the cysteinyl leukotriene receptor antagonists, have anti-inflammatory and bronchodilating effects. The clinical indications for LT antagonist are not yet in consensus. We performed a non-comparative multicenter trial to assess the additional responses of Accolate to the current long-term control regimens in persistent asthma.
MATERIALS AND METHODS
Eighty persistent asthmatics from 10 asthma special care clinics were enrolled. Daily 20 mg of Accolate was added 2 times to the current control regimen for 6 weeks and its effects on symptom scores, morning and evening PEFR, FEV1, and frequency of the short acting 2 agonist usage for relief of asthma were measured.
RESULTS
The morning symptom scores significantly improved by addition of Accolate for 1 week (p<0.01) and its effect persisted to the 6th week (p<0.01) of trial. Nocturnal symptom scores also improved at 2nd week (p<0.05) and the effect continued to the end of this trial. Days with morning asthma symptoms decreased by addition of Accolate at 4th week (p<0.05) and 6th week (p<0.05). The frequency of the short acting beta2 agonist inhalations significantly decreased by addition of Accolate from 1st week to the end of this trial. Morning and evening PEFR significantly improved at 1st week and the effects progressively improved to the end of this trial. The FEV1 not improve by addition of Accolate. However, when the asthmatics with obstructed lung function (FEV1 <80%) were enrolled only for analysis, the FEV1 significantly improved at 3rd (p<0.05) and 6th weeks (p<0.05). In 21 asthmatics, oral prednisolone was continuously used at the beginning of this trial. It could be discontinued in 4 patients and the dosage of prednisolone was significantly reduced in another 3 patients by addition of Accolate. Their mean administered dosage of prednisolone decreased from 8.6+/-0.9 mg/day to 6.8+/-1.1 mg/day at the end of this trial (p<0.05).
CONCLUSIONS
With these results, we thought that addition of Accolate as a long term control regimen in the symptomatic persistent asthmatics would be an effective strategy. For evaluation of steroid sparing effects, further studies will be needed.