Moderate to Persistent Asthma in the Obese Subject
Overview[ - collapse ][ - ]
| Purpose | 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. |
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| Condition | Asthma |
| Intervention | Drug: Montelukast Other: Sugar pill |
| Phase | Phase 4 |
| Sponsor | Duke University |
| Responsible Party | Duke University |
| ClinicalTrials.gov Identifier | NCT01016847 |
| First Received | October 19, 2009 |
| Last Updated | December 19, 2012 |
| Last verified | December 2012 |
Tracking Information[ + expand ][ + ]
| First Received Date | October 19, 2009 |
|---|---|
| Last Updated Date | December 19, 2012 |
| Start Date | January 2010 |
| Estimated Primary Completion Date | September 2014 |
| Current Primary Outcome Measures | Determine the effect of montelukast / moderate dose ICS versus high dose ICS on asthma control as measured by the asthma control questionnaire. [Time Frame: September 2014] [Designated as safety issue: No] |
| Current Secondary Outcome Measures | Serum adiponectin, leptin, tumor necrosis alpha (TNF-α) and interleukin 6 (IL6) levels [Time Frame: September 2014] [Designated as safety issue: No] |
Descriptive Information[ + expand ][ + ]
| Brief Title | 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 |
| 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. |
| Study Type | Interventional |
| Study Phase | Phase 4 |
| Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Diagnostic |
| Condition | Asthma |
| Intervention | Drug: Montelukast 10 mg Q day Other: Sugar pill Sugar pill that looks like Montelukast that will be given Q day |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Recruiting |
|---|---|
| Estimated Enrollment | 25 |
| Estimated Completion Date | September 2014 |
| Estimated Primary Completion Date | November 2013 |
| 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: - 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 |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Contact: Denise M Beaver, AAS 919-479-0719 denise.beaver@duke.edu |
| Location Countries | United States |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01016847 |
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| Other Study ID Numbers | Pro00018748 |
| Has Data Monitoring Committee | Yes |
| Information Provided By | Duke University |
| Study Sponsor | Duke University |
| Collaborators | Not Provided |
| Investigators | Not Provided |
| Verification Date | December 2012 |
Locations[ + expand ][ + ]
| Duke Asthma Allergy and Airway Center | Durham, North Carolina, United States, 27704 Principal Investigator: Monica Kraft, M.D.Recruiting |
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