MedDataX Logo

Moderate to Persistent Asthma in the Obese Subject

NCT ID: NCT01016847

Last Updated: 2014-11-17

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2013-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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and will be placed on inhaled corticosteroids at moderate doses and leukotriene receptor antagonists will be withdrawn (LTRA wash-out).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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Asthma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

leukotriene receptor antagonist (LTRA) montelukast

Montelukast (LTRA) administered with moderate dose of inhaled steroid

Group Type ACTIVE_COMPARATOR

Montelukast

Intervention Type DRUG

10 mg Q day

Sugar Pill

High dose of inhaled steroid administered with sugar pill

Group Type PLACEBO_COMPARATOR

Sugar pill

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Montelukast

10 mg Q day

Intervention Type DRUG

Sugar pill

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Duke University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Duke Asthma Allergy and Airway Center

Durham, North Carolina, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Pro00018748

Identifier Type: -

Identifier Source: org_study_id