Clinical trial NCT01016847: Moderate to Persistent Asthma in the Obese Subject
Official title: A Randomized, Double-Blind, Placebo-Controlled, Cross-over Study to Evaluate the Effect of the Leukotriene Antagonist (Singulair©) Plus Moderate Dose Beclomethasone Compared to High Dose Beclomethasone in Obese Subjects With Moderate Persistent Asthma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Asthma
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2009-11-20
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: 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and will be placed on inhaled corticosteroids at moderate doses and leukotriene receptor antagonists will be withdrawn (LTRA wash-out).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.

Eligibility criteria: Inclusion Criteria:

* moderate persistent asthma as defined daily symptoms, nocturnal awakenings \>1 time/week but not daily, daily short-acting beta agonist usage
* pre-bronchodilator Force expiratory volume (FEV1)\>55% but \<90%.
* Subjects must be on controller therapy for asthma with ICS for at least one month prior to enrollment.
* methacholine testing that causes a drop in the FEV1 of 20% (8mg/ml off ICS or 16mg/ml) on ICS within 6 months prior to entry
* physician diagnosis of asthma for at least one year prior to study enrollment.
* Obesity defined as BMI greater than 30.
* subjects must have an Asthma Control Questionnaire (ACQ) score \>1.25 on the Juniper Asthma Control Questionnaire (indicating poor asthma control),
* require daily medications for asthma and be compliant with study related medications.

Exclusion Criteria:

* Subjects must not have been intubated in the last 5 years or unstable asthma symptoms resulting in significant loss or work or school
* upper or lower respiratory tract infection within 1 month of the study
* use of antibiotics within 4 weeks of the study
* use of oral glucocorticoids within 4 weeks
* use of theophylline
* smoking history greater than 10 pack years or any cigarette use within the past two years
* significant non-asthma pulmonary disease or other medical problems
* Subjects planning to undergo gastric bypass surgery within 4 months of the enrollment date will be excluded since weight loss is a potential confounder of asthma control
* Pregnant women will also be excluded

Primary outcomes:
measure: Determine the Effect of Montelukast / Moderate Dose ICS Versus High Dose ICS on Asthma Control as Measured by the Asthma Control Questionnaire.
timeFrame: Baseline/randomization to week 16
Secondary outcomes:
measure: Serum Adiponectin, Leptin, Tumor Necrosis Alpha (TNF-α) and Interleukin 6 (IL6) Levels
timeFrame: Baseline/randomization to week 16
measure: Post Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)
timeFrame: Baseline/randomization to week 16
measure: Change in Trends in Asthma Control Questionnaire (ACQ ACTQ) Scores Over Duration of the Study
timeFrame: Baseline/randomization to week 16
measure: Asthma Exacerbation
timeFrame: Baseline/randomization to week 16
measure: Sputum Cell Counts and Differentials
timeFrame: Baseline/randomization to week 16
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Asthma Allergy and Airway Center
state: North Carolina
Study officials:
References: