Asthma
Conditions
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and will be placed on inhaled corticosteroids at moderate doses and leukotriene receptor antagonists will be withdrawn (LTRA wash-out).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.
Interventions
DRUGMontelukast
10 mg Q day
OTHERSugar pill
Sugar pill that looks like Montelukast that will be given Q day
Sponsors
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determine the Effect of Montelukast / Moderate Dose ICS Versus High Dose ICS on Asthma Control as Measured by the Asthma Control Questionnaire. | Baseline/randomization to week 16 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum Adiponectin, Leptin, Tumor Necrosis Alpha (TNF-α) and Interleukin 6 (IL6) Levels | Baseline/randomization to week 16 | — |
| Post Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) | Baseline/randomization to week 16 | — |
| Change in Trends in Asthma Control Questionnaire (ACQ ACTQ) Scores Over Duration of the Study | Baseline/randomization to week 16 | — |
| Asthma Exacerbation | Baseline/randomization to week 16 | 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. |
| Sputum Cell Counts and Differentials | Baseline/randomization to week 16 | — |
Countries
United States
Participant flow
Pre-assignment details
38 subjects enrolled in study. Of the 38 subjects 10 were screen failures, and 25 were withdrawn during the 2 week run-in period.
Participants by arm
| Arm | Count |
|---|---|
| Leukotriene Receptor Antagonist (LTRA) Montelukast Montelukast (LTRA) administered with moderate dose of inhaled steroid
Montelukast: 10 mg Q day | 1 |
| Sugar Pill High dose of inhaled steroid administered with sugar pill
Sugar pill: Sugar pill that looks like Montelukast that will be given Q day | 2 |
| Total | 3 |
Baseline characteristics
| Characteristic | Leukotriene Receptor Antagonist (LTRA) Montelukast | Sugar Pill | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 1 Participants | 1 Participants | 2 Participants |
| Region of Enrollment United States | 1 participants | 2 participants | 3 participants |
| Sex: Female, Male Female | 0 Participants | 2 Participants | 2 Participants |
| Sex: Female, Male Male | 1 Participants | 0 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 1 | 0 / 2 |
| serious Total, serious adverse events | 0 / 1 | 0 / 2 |
Outcome results
Primary
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
Population: Due to insufficient accrual, data analysis was not performed.
Secondary
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
Population: Due to insufficient accrual, data analysis was not performed.
Secondary
Change in Trends in Asthma Control Questionnaire (ACQ ACTQ) Scores Over Duration of the Study
Time frame: Baseline/randomization to week 16
Population: Due to insufficient accrual, data analysis was not performed.
Secondary
Post Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)
Time frame: Baseline/randomization to week 16
Population: Due to insufficient accrual, data analysis was not performed.
Secondary
Serum Adiponectin, Leptin, Tumor Necrosis Alpha (TNF-α) and Interleukin 6 (IL6) Levels
Time frame: Baseline/randomization to week 16
Population: Due to insufficient accrual, data analysis was not performed.
Secondary
Sputum Cell Counts and Differentials
Time frame: Baseline/randomization to week 16
Population: Due to insufficient accrual, data analysis was not performed.