Moderate to Persistent Asthma in the Obese Subject

Asthma Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01016847
• Other study ID #: Pro00018748
• Status: Terminated
• Phase: Phase 4
• First received: October 19, 2009
• Last updated: November 7, 2014
• Start date: January 2010
• Est. completion date: November 2013

Study information

• Verified date: December 2012
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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and will be placed on inhaled corticosteroids at moderate doses and leukotriene receptor antagonists will be withdrawn (LTRA wash-out).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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 38
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Montelukast
10 mg Q day

Other:
• Sugar pill
Sugar pill that looks like Montelukast that will be given Q day

Locations

Country	Name	City	State
United States	Duke Asthma Allergy and Airway Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Serum Adiponectin, Leptin, Tumor Necrosis Alpha (TNF-a) and Interleukin 6 (IL6) Levels		Baseline/randomization to week 16	No
Secondary	Post Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)		Baseline/randomization to week 16	No
Secondary	Change in Trends in Asthma Control Questionnaire (ACQ ACTQ) Scores Over Duration of the Study		Baseline/randomization to week 16	No
Secondary	Asthma Exacerbation	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.	Baseline/randomization to week 16	No
Secondary	Sputum Cell Counts and Differentials		Baseline/randomization to week 16	No