Moderate to Persistent Asthma in the Obese Subject

NCT01016847 | Terminated Phase 4 Results DMC

• 1 other identifier: Pro00018748
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

• Sputum Cell Counts and Differentials

  Baseline/randomization to week 16

Study Arms (2)

leukotriene receptor antagonist (LTRA) montelukast

ACTIVE COMPARATOR

Montelukast (LTRA) administered with moderate dose of inhaled steroid

Drug: Montelukast

Sugar Pill

PLACEBO COMPARATOR

High dose of inhaled steroid administered with sugar pill

Other: Sugar pill

Interventions

Montelukast DRUG

10 mg Q day

leukotriene receptor antagonist (LTRA) montelukast

Sugar pill OTHER

Sugar pill that looks like Montelukast that will be given Q day

Sugar Pill

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke Asthma Allergy and Airway Center

Durham, North Carolina, 27704, United States

Location

MeSH Terms

Conditions

Asthma

Interventions

montelukast; Sugars

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Carbohydrates

Limitations and Caveats

Early terminiation due to poor enrollment.

Results Point of Contact

• Title: Monica Kraft, M.D.
• Organization: Duke Asthma Allergy and Airway Center

denise.beaver@dm.duke.edu

9194790719

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2009
• First Posted: November 20, 2009
• Study Start: January 1, 2010
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: November 17, 2014
• Results First Posted: November 17, 2014

Record last verified: 2012-12

Locations

US (1)