Moderate to Persistent Asthma in the Obese Subject

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01016847
Recruitment Status : Terminated (Unable to enroll enough study subjects. Study has been terminated)
First Posted : November 20, 2009
Results First Posted : November 17, 2014
Last Update Posted : November 17, 2014
Information provided by (Responsible Party):
Duke University

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.

Condition or disease Intervention/treatment Phase
Asthma Drug: Montelukast Other: Sugar pill Phase 4

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and will be placed on inhaled corticosteroids at moderate doses and leukotriene receptor antagonists will be withdrawn (LTRA wash-out).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  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Diagnostic
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 Start Date : January 2010
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Montelukast

Arm Intervention/treatment
Active Comparator: leukotriene receptor antagonist (LTRA) montelukast
Montelukast (LTRA) administered with moderate dose of inhaled steroid
Drug: Montelukast
10 mg Q day

Placebo Comparator: Sugar Pill
High dose of inhaled steroid administered with sugar pill
Other: Sugar pill
Sugar pill that looks like Montelukast that will be given Q day

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Serum Adiponectin, Leptin, Tumor Necrosis Alpha (TNF-α) and Interleukin 6 (IL6) Levels [ Time Frame: Baseline/randomization to week 16 ]
  2. Post Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: Baseline/randomization to week 16 ]
  3. Change in Trends in Asthma Control Questionnaire (ACQ ACTQ) Scores Over Duration of the Study [ Time Frame: Baseline/randomization to week 16 ]
  4. Asthma Exacerbation [ Time Frame: 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.

  5. Sputum Cell Counts and Differentials [ Time Frame: Baseline/randomization to week 16 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01016847

United States, North Carolina
Duke Asthma Allergy and Airway Center
Durham, North Carolina, United States, 27704
Sponsors and Collaborators
Duke University

Responsible Party: Duke University Identifier: NCT01016847     History of Changes
Other Study ID Numbers: Pro00018748
First Posted: November 20, 2009    Key Record Dates
Results First Posted: November 17, 2014
Last Update Posted: November 17, 2014
Last Verified: December 2012

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Anti-Asthmatic Agents
Respiratory System Agents
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents