Obesity is associated with increased airway inflammation and asthma severity that results in suboptimal control of asthma despite therapy with high dose inhaled corticosteroids (ICS). The investigators suggested that the addition of Singular (montelukast)\[LTRA\] to moderate doses of inhaled corticosteroids will improve asthma control. This cross over study will be treat subjects with moderate dose ICS/LTRA for 12 weeks and high dose ICS with placebo for 12 weeks.
Subjects will enter the 2-week run-in period after meeting eligibility criteria at the screening visit (visit 1). During run-in subjects will have all usual asthma medications discontinued and will be placed on inhaled corticosteroids at moderate doses and leukotriene receptor antagonists will be withdrawn (LTRA wash-out). Subjects will be monitored to rule out any acute infection or symptoms consistent with an exacerbation. The run-in period will be used to assess subject compliance and understanding of study related procedures. Following the run-in, to be eligible for the randomization subjects must have an ACQ score \>1.25 on the Juniper Asthma Control Questionnaire.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
TRIPLE
Enrollment
38
10 mg Q day
Sugar pill that looks like Montelukast that will be given Q day
Duke Asthma Allergy and Airway Center
Durham, North Carolina, United States
Determine the Effect of Montelukast / Moderate Dose ICS Versus High Dose ICS on Asthma Control as Measured by the Asthma Control Questionnaire.
Time frame: Baseline/randomization to week 16
Serum Adiponectin, Leptin, Tumor Necrosis Alpha (TNF-α) and Interleukin 6 (IL6) Levels
Time frame: Baseline/randomization to week 16
Post Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)
Time frame: Baseline/randomization to week 16
Change in Trends in Asthma Control Questionnaire (ACQ ACTQ) Scores Over Duration of the Study
Time frame: Baseline/randomization to week 16
Asthma Exacerbation
Asthma exacerbation is defined as the development of an increase in asthma symptoms which results in an increase in the use of asthma medications (typically inhaled corticosteroids and/or parenteral corticosteroids) or the addition of another new asthma medication or antibiotics.
Time frame: Baseline/randomization to week 16
Sputum Cell Counts and Differentials
Time frame: Baseline/randomization to week 16
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.