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Moderate to Persistent Asthma in the Obese Subject

This study has been terminated.
(Unable to enroll enough study subjects. Study has been terminated)
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01016847
First received: October 19, 2009
Last updated: November 7, 2014
Last verified: December 2012
  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.


Condition Intervention Phase
Asthma
Drug: Montelukast
Other: Sugar pill
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Duke University:

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: Baseline/randomization to week 16 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Serum Adiponectin, Leptin, Tumor Necrosis Alpha (TNF-α) and Interleukin 6 (IL6) Levels [ Time Frame: Baseline/randomization to week 16 ] [ Designated as safety issue: No ]
  • Post Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: Baseline/randomization to week 16 ] [ Designated as safety issue: No ]
  • Change in Trends in Asthma Control Questionnaire (ACQ ACTQ) Scores Over Duration of the Study [ Time Frame: Baseline/randomization to week 16 ] [ Designated as safety issue: No ]
  • Asthma Exacerbation [ Time Frame: Baseline/randomization to week 16 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline/randomization to week 16 ] [ Designated as safety issue: No ]

Enrollment: 38
Study Start Date: January 2010
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01016847

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

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01016847     History of Changes
Other Study ID Numbers: Pro00018748
Study First Received: October 19, 2009
Results First Received: November 7, 2014
Last Updated: November 7, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases
Leukotriene Antagonists
Montelukast
Anti-Asthmatic Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014