Moderate to Persistent Asthma in the Obese Subject

• Status: Terminated
• Trial end date: 2013-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Duke University
• Treatments: Beclomethasone; Montelukast

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