Montelukast Post-Marketing Comparative Study With Ketotifen
Summary
The clinical study evaluates the safety of montelukast and compares montelukast to ketotifen, used as a control drug, in terms of improvement in morning peak expiratory flow (am pef) over first 2 weeks in patients with pediatric bronchial asthma aged 6 to < 15.
The effect of body weight on the efficacy and safety of montelukast will also be evaluated in this study.
Study Design
Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Conditions
Asthma
Intervention
MK0476, montelukast sodium / Duration of Treatment: 4 Weeks, Comparator: ketotifen / Duration of Treatment: 4 Weeks
Status
Completed
Source
Merck
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00446056
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Ketotifen
A cycloheptathiophene blocker of histamine H1 receptors and release of inflammatory mediators. It has been proposed for the treatment of asthma, rhinitis, skin allergies, and anaphylaxis.
Term Birth
CHILDBIRTH at the end of a normal duration of PREGNANCY, between 37 to 40 weeks of gestation or about 280 days from the first day of the mother's last menstrual period.
Pregnancy Trimesters
The three approximately equal periods of a normal human PREGNANCY. Each trimester is about three months or 13 to 14 weeks in duration depending on the designation of the first day of gestation.
Sodium, Dietary
Sodium or sodium compounds used in foods or as a food. The most frequently used compounds are sodium chloride or sodium glutamate.
Extreme Heat
High temperature weather exceeding the average and of several weeks duration. Extreme heat is a dangerous situation that can bring on health emergencies in susceptible people.
Clinical Trials
The purpose of this study is to compare the effect of montelukast with placebo and beclomethasone on the average rate of linear growth over a period of 56 weeks in children with mild asthm...
Subjects have 8-week with montelukast sodium or comparator drug administration period, 2-week wash-out period and 8-week comparator drug or the drug administration period (with cross-over...
First Step With Singulair® Therapy
In adult patients with mild persistent asthma, singulair® 10 mg will be at least as effective as low dose Inhaled Corticosteroids (ICS) in improving asthma symptom control or satisfaction...
To evaluate the changes in proinflammatory markers (ltd4 in urine) and eosinophil from peripheral blood after newly initiated montelukast therapy.
A study to assess the clinical effect of montelukast sodium with concomitant administration of inhaled budesonide in asthmatic patients.
PubMed Articles
Risk Factors for Montelukast Treatment Failure in Step-Down Therapy for Controlled Asthma.
Background. Leukotriene receptor antagonists including montelukast are an option for step-down therapy for mild asthmatics controlled on low-dose inhaled corticosteroids (ICS). Because some patients f...
Effect of clarithromycin and fluconazole on the pharmacokinetics of montelukast in human volunteers.
OBJECTIVE: Montelukast, a leukotriene receptor antagonist, is used in the treatment of asthma. The objective of the study reported here was to determine whether multiple doses of clarithromycin or flu...
Efficacy of montelukast as added therapy in patients with chronic idiopathic urticaria.
Chronic idiopathic urticaria is a common skin disorder characterized by recurrent appearance of wheals and/or angioedema for more than 6 weeks without an identifiable cause. Consensus guidelines sugge...
Background. The efficacy of oral montelukast has been well established in asthma and allergic rhinitis in adults and children. The purpose of this study was to evaluate dose-related bronchodilation an...
Background Mast cell activation is thought to be involved in visceral hypersensitivity, one of the main characteristics of the irritable bowel syndrome (IBS). A study was therefore undertaken to inves...
