Table 2 Studies that demonstrated inferiority of MLK compared to ICS
From: Montelukast versus inhaled corticosteroids in the management of pediatric mild persistent asthma
First author, year [ref] | Study duration | Patients (Age) | Drugs doses | Results |
|---|---|---|---|---|
Stelmach, 2004[49] | 4 weeks | 256 pts (6–18 years) | MLK = 5–10 mg /d TRC = 400 μg /d | With TRC and MLK, FEV1 and PC20 significantly increased; mean total symptoms score and EOS significantly decreased. TRC had a stronger effect on PC20 than MLK and in reduction in β2-a use, similar improvement in clinical symptoms. |
Ostrom, 2005[16] | 12 weeks | 342 pts (6–12 years) | MLK = 5 mg/d FP = 100 μg/d | FP (vs MLK) significantly increased % change from baseline FEV1, PEF, % RFDs and reduced night time symptom scores and β2-a use. |
Szefler, 2005[39] | 8 weeks | 144 pts (6–17 years) | MLK = 5–10 mg/d FP = 200 μg/d | FEV1 improvement was 6.8% for FP and 1.9% for MLK (mean difference 4,9%, p = <0,001). ICS therapy is better if low pulmonary function and high levels of allergic inflammation markers. |
Zeiger, 2006[50] | 8 weeks | 144 pts (6–17 years) | MLK = 5–10 mg/d FP = 200 μg/d | Significantly greater improvement in ACDs/week with FP than MLK (p = 0.001). Clinical outcomes, pulmonary responses and inflammatory biomarkers improved significantly more with FP than with MLK. |
Sorkness, 2007[51] | 48 weeks | 285 pts (6–14 years) | MLK = 5 mg/d FP = 200 μg/d PACT = FP 100 μg + LABA 100 μg/d | Significantly greater improvement with FP vs MLK (p = 0.004). FP group had a longer time to first prednisone burst and to a treatment failure, fewer treatment failure, better FEV1, FEV1/FVC, PEF, PC20, symptoms score and lower eNO level than MLK group. |
Knuffman, 2009[52] | 48 weeks | 191 pts (6–14 years) | MLK = 5 mg /d FP = 200 μg /d PACT combination = FP 100 μg + LABA 100 μg/d | A history of parental asthma best predicted the expected treatment benefit with FP vs MLK in terms of gain in ACDs and time to first exacerbation; elevated baseline eNO predicted response for FP regarding the gain in ACDs; prior ICS use and low PC20 each predicted the expected treatment benefit with FP over MLK regarding time to first exacerbation. |
Szefler, 2007[53] | 52 weeks | 395 pts (2–8 years) | MLK = 4–5 mg /d BD = 0,5 mg /d | Both treatments provided acceptable asthma control; however, peak flow and caregiver and Physician Global Assessments favored IBD. |