A randomized, double-blind, placebo-controlled trial of oral montelukast in acute asthma exacerbation

Zubairi, Ali Bin Sarwar; Salahuddin, Nawal; Khawaja, Ali; Awan, Safia; Shah, Adil A.; Haque, Ahmed Suleman; Husain, Shahid Javed; Rao, Nisar Ahmed; Khan, Jibran

doi:10.1186/1471-2466-13-20

Cited by 24 publications

(18 citation statements)

References 20 publications

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“…Oral LTRA are generally not included in the treatment guidelines of AEA [3,14,75]. A recent randomized, double-blind, placebocontrolled trial of oral montelukast in adults with AEA failed to show benefit [76]. This result is consistent with a systematic review of eight trials of LTRA which also did not support their oral use in AEA.…”

Section: Leukotriene Modulatorssupporting

confidence: 76%

The Acute Management of Asthma

Albertson

Sutter

Chan

2014

Clinic Rev Allerg Immunol

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Patients presenting to the emergency department (ED) or clinic with acute exacerbation of asthma (AEA) can be very challenging varying in both severity and response to therapy. High-dose, frequent or continuous nebulized short-acting beta2 agonist (SABA) therapy that can be combined with a short-acting muscarinic antagonist (SAMA) is the backbone of treatment. When patients do not rapidly clinically respond to SABA/SAMA inhalation, the early use of oral or parenteral corticosteroids should be considered and has been shown to impact the immediate need for ICU admission or even the need for hospital admission. Adjunctive therapies such as the use of intravenous magnesium and helium/oxygen combination gas for inhalation and for driving a nebulizer to deliver a SABA and or SAMA should be considered and are best used early in the treatment plan if they are likely to impact the patients' clinical course. The use of other agents such as theophylline, leukotriene modifiers, inhaled corticosteroids, long-acting beta2 agonist, and long-acting muscarinic antagonist currently does not play a major role in the immediate treatment of AEA in the clinic or the ED but is an important therapeutic option for physicians to be aware of and to consider initiating at the time of discharge from clinic, hospital, or ED to reduce later clinical worsening and readmission to the ED and hospital. A comprehensive summary is provided of the currently available respiratory pharmaceuticals approved for asthma and other airway syndromes. Clinicians must be prepared to use the entire spectrum of medications available for the treatment of acute asthma exacerbations and the agents that should be initiated to prevent worsening or additional exacerbations. They need to be familiar with the major potential drug toxicities associated with their use.

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Section: Leukotriene Modulatorssupporting

confidence: 76%

The Acute Management of Asthma

Albertson

Sutter

Chan

2014

Clinic Rev Allerg Immunol

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“…This reduces the bronchoconstriction otherwise caused by the leukotriene and results in less inflammation. Because of its method of operation, it is not useful for the treatment of acute asthmatic attacks 55. The cysteinyl leukotrienes C4, D4, and E4 are end products of the arachidonic acid pathway and are potent mediators of antigen-induced contractions of airway smooth muscle 56.…”

Section: Montelukast As a Class Of Immunomodulant For Asthmamentioning

confidence: 99%

Clinical effectiveness and safety of montelukast in asthma. What are the conclusions from clinical trials and meta-analyses?

Hon¹,

Leung²,

Leung³

2014

DDDT

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Asthma is a common childhood atopic disease associated with chronicity and impaired quality of life. As there is no cure for this disease, treatment relies on avoidance of triggers such as food and aeroallergens, the use of inhaled bronchodilators/corticosteroids and antiallergic or immunomodulating therapies. Inhaled corticosteroids (ICSs) and bronchodilators have been the mainstay. However, in Asia, myths and fallacies regarding Western medicine and corticosteroids are prevalent and lead to nonadherence to treatment. Also, use of traditional and proprietary herbal medicines is popular. In the past decades, a novel class of nonsteroidal immunomodulating montelukasts has become available. This article reviews the evidence for the effectiveness and clinical efficacy of these medications. A number of randomized and controlled trials have been performed over the years. The majority of studies confirm the usefulness of montelukast as monotherapy and add-on therapy to ICS in mild to moderate childhood asthma across all age groups. ICSs are generally superior to montelukasts for asthma management. However, montelukast has a place in the treatment of young children with viral-triggered wheezing diseases, exercise-induced asthma, and in children whose parents are steroid-phobic and find ICS unacceptable.

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“…Gaddy et al, 15 showed that intravenous leukotriene receptor antagonists could produce a 22% improvement in FEV1 from baseline in those with stable asthma with a baseline FEV1 of 50% -80% predicted. However, a study by Zubairi et al, 16 did not observe any significant differences in FEV1 and PEFR at admission and discharge in patients hospitalized with acute asthma exacerbations that were given oral Montelukast versus placebo. Nelson et al, 17 did not observed any improvement in FEV1 among children aged 6-14years taking oral Montelukast in acute attack of asthma and concluded that oral Montelukast has got no role in the acute attack of bronchial asthma.…”

Section: Discussionmentioning

confidence: 93%

“…In another study, Zubairi et al, 16 had observed that there was no significant difference in PEFR during the hospital stay and at discharge with oral Montelukast therapy. Ferreira et al, 18 observed that Montelukast group had shorter duration of hospital stay and better evolution of PEFR values (Median increase of 55% from baseline versus 44% in placebo group) but this did not reach statistical significance.…”

Section: Discussionmentioning

confidence: 99%

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Role of Oral Montelukast in Acute Asthma Exacerbations : A Randomized Placebo Controlled Trial

Gajanan¹,

Chaudhury²,

Hattiholi³

2015

jemds

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BACKGROUND: Leukotriene receptor antagonists (LTRAs) are well established in the management of outpatient asthma. However, there is very little information as to their role in acute asthma exacerbations. The present study was done to evaluate the clinical efficacy of oral Montelukast as an add on therapy to the usual standard therapy of acute attack of bronchial asthma. MATERIALS AND METHODS:A randomized single blinded controlled study was conducted in a tertiary care teaching hospital. A total of 320 patients with age >18 years of acute exacerbations due to bronchial asthma were included in the study. The patients were randomized into two study and control groups. The study group patients received oral Montelukast (10mg) once daily for 2 weeks, while the control group received a placebo. All the patients received standard therapy according to GINA guidelines. Improvements in lung function tests, clinical symptoms and relapse rates were monitored at baseline, at discharge and at 2 weeks. Side effects profile was also monitored. RESULTS: A total of 255 patients were finally assessed. One hundred thirty patients belonged to study group and 125 in the control group. Baseline characteristics were similar and well matched in both the groups. Mean age was 39.9±15.8 years in study group and 42.8±12.8 in the control group and majority were female patients in both the groups. At the end of 2 weeks, it was observed that there were no significant improvements in FEV1 and FVC as compared to the control group. However, there was significant improvement in PEFR at 2 weeks (0.4 L/sec, 12%) as compared to the control group (p <0.0376). Length of hospital stay was similar in both the groups. No serious adverse effects were noted during the course of the study. CONCLUSIONS: In acute asthma exacerbations, the present study showed that additional administration of oral Montelukast resulted in significantly higher PEFR at 2 weeks as compared to the standard treatment alone. These findings should be confirmed by conducting a larger population based clinical study.

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A randomized, double-blind, placebo-controlled trial of oral montelukast in acute asthma exacerbation

Cited by 24 publications

References 20 publications

The Acute Management of Asthma

The Acute Management of Asthma

Clinical effectiveness and safety of montelukast in asthma. What are the conclusions from clinical trials and meta-analyses?

Role of Oral Montelukast in Acute Asthma Exacerbations : A Randomized Placebo Controlled Trial

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