Moderate to Persistent Asthma in the Obese Subject
| Status: | Completed |
|---|---|
| Conditions: | Asthma |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 2/7/2015 |
| Start Date: | January 2010 |
| End Date: | September 2014 |
| Contact: | Denise M Beaver, AAS |
| Email: | denise.beaver@duke.edu |
| Phone: | 919-479-0719 |
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
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.
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receptor antagonists will be withdrawn (LTRA wash-out).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.
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receptor antagonists will be withdrawn (LTRA wash-out).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.
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:
- ACQ score <1.25 at randomization
- FEV1<55% predicted,
- inpatient status,
- unstable asthma symptoms (causing significant loss of work or school)
- upper or lower respiratory tract infection for 1 month
- use of theophylline,
- smoking history greater than 5 pack years or any cigarette use within the past two
years,
- significant non-asthma pulmonary disease or other medical problems.
- planning to undergo gastric bypass surgery within 4 months
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