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Journal Reporting
Dr. Pravinkumar A. WahaneJR II, Dept. Of Pharmacology
B.J.G.M.C. Pune
A randomized, double-blind, placebo controlled trial of oral montelukast in acute asthma exacerbation
Ali Bin S Z, Nawal S, Ali K, Safia A et al.
BMC Pulmonary Medicine 2013, 13:20, 1-7
Introduction
Asthma associated with chronic airway inflammation with recruitment of a number of inflammatory cells including T-cells, mast cells and eosinophils
Ranked as major contributor to emergency department visits
Incidence is on rise all across world, especially in paediatric population, with bronchial asthma accounting for 4% of the paediatric out-patient visits
Introduction
Interaction of these mediators with the Type 1 cysteinyl leukotriene receptors (CysLT-1), located on inflammatory cells and structural cells of airways implicated in :
Inflammatory cell infiltration,
Initiation of bronchial smooth muscle contraction,
Mucus secretion and
Increased vascular permeability
Ultimately leads to airway narrowing Montelukast is M.C. used (CysLT-1) antagonist
Introduction
Shown to improve symptoms & lung function (FEV1) within 15 minutes of administration in chronic asthma with its effects lasting for a period of at least 24 hours
Existing therapeutic modalities for acute asthma include oxygen and short acting β2 agonist bronchodilators in order to promptly reverse airflow obstruction
Hypothesis Treatment with a leukotriene receptor antagonist (LTRA),
montelukast sodium would improve airway obstruction and clinical outcomes in acute asthma exacerbation and would subsequently decrease the duration of hospital stay
Materials and Methods
Randomized, double-blind, placebo controlled parallel group drug trial conducted over a period of two years from February 2006 to February 2008 in Tertiary care hospital
Patients presenting to the emergency department with acute asthma exacerbation were included in study after primary screening
Ethics Review Committee approval was Obtained
Informed Consent obtained from subjects before inclusion in the study
Materials and Methods
Inclusion Criteria Diagnosis of acute asthma exacerbation that required
hospitalization as defined by the Global Initiative for Asthma (GINA) Guidelines Pts. with FEV1 < 70% predicted aged 16 yrs or more Pts. with PEF < 300 L/min aged 16 yrs or more
After receiving 30 minutes of initial treatment in the ER Respiratory rate > 24 breaths/min No improvement in symptoms such as shortness of breath
or wheezing
Materials and Methods
Exclusion Criteria Age <15 years , Pregnancy FEV1 > 70% predicted OR PEF > 300 L/min History of tobacco use of >10 years Concomitant therapy with systemic Corticosteroids or
leukotriene modifiers at any time in the past 4 weeks at the time of admission
Any concurrent acute medical condition like AMI, CCF, DKA or Shock
Acute respiratory failure requiring mechanical ventilation
Study Procedure
Patients were assigned to Treatment group (Montelukast) and Placebo group randomly by computer generated randomization sequence
Patients in Group 1 (Treatment Group) : -
Received standard therapy & oral montelukast sodium (10 mg once daily)
Patients in Group 2 (Placebo Group) :-
Received standard therapy along with a placebo
Study Design
Outcome Assessment
Primary Outcomes Improvement in lung function measured as PEF and
FEV1 over the course of hospital stay and discharge Duration of hospital stay
Secondary Outcomes Development of complications such as :
Respiratory failure, Cardiac arrest and/or Death
Statistical Analysis
Categorical variables were analyzed using Chi-square test
Continuous variables were analyzed using Fisher exact
All analyses were conducted by using the Statistical package for social science (SPSS Release 15.0)
p-values were considered as statistically significant if < 0.05
Results : Baseline Characteristics
Results : Baseline Characteristics
RESULTS
Primary outcome measures
No significant difference in the PEF between both treatment groups during the hospital stay and at discharge
No Statistically significant difference in Mean PEF of Montelukast and Placebo groups at time of discharge
No Statistically significant difference in Mean FEV1 in Montelukast and Placebo groups at time of discharge
Mean duration of Hospital stay for patients belonging to montelukast and placebo groups was 3.67 ± 1.86 days and 3.72 ± 2.02 days respectively (p – 0.90)
Primary outcome measures
Primary outcome measures
Secondary outcome measures Two patients, one from each arm, developed respiratory
failure
No patient in either group was withdrawn due to worsening asthma or adverse drug effect from the study
Discussion
Study did not reveal significant differences in : PFTs measured as FEV1 at admission and discharge &
PEF measured at specific intervals Length of hospital stay in patients hospitalized with
acute asthma exacerbation that were given oral montelukast vs. placebo
Efficacy and tolerability profile of oral montelukast were comparable to placebo and no serious adverse effects were encountered
Study findings were not consistent with Ramsay et al, Silverman et al, Camarago et. al. & Adaichi et. al.
Conclusion
Study suggests that there is no added benefit of using montelukast along with the standard therapy for the management of acute asthma exacerbation in hospitalized adult population
Larger scale multicentre trials needed to better evaluate the role of cysteinyl leukotriene's antagonists in treating acute exacerbations of asthma
Comments
Clinical Trial Registration No. - Mentioned Title – Gives clear idea about aim and study design but not
about the dosing pattern / route of administration of Montelukast
Introduction – Background information and purpose of study mentioned
Materials and Methods – Ethical Approval and informed consent has been obtained
Place ,Duration of study and Study design mentioned Randomization method & inclusion / Exclusion criteria
mentioned
Comments
Source of Drug – Mentioned
Results – Statistical Test applied mentioned, Statistical software used for analysis mentioned, appropriate tables and figures included
Discussion – Results repeated, Relevant studies mentioned, Limitations of the study mentioned
Results - Emphasizes need for further studies regarding Montelukast use in acute exacerbation of asthma
Supports and Conflict of Interest - Mentioned as Nil
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