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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


Phase 4
18 Years
65 Years
Open (Enrolling)
Both
Asthma

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Trial Information

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


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receptor antagonists will be withdrawn (LTRA wash-out).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.


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:

- ACQ score <1.25 at randomization

- FEV1<55% predicted,

- inpatient status,

- unstable asthma symptoms (causing significant loss of work or school)

- upper or lower respiratory tract infection for 1 month

- use of theophylline,

- smoking history greater than 5 pack years or any cigarette use within the past two
years,

- significant non-asthma pulmonary disease or other medical problems.

- planning to undergo gastric bypass surgery within 4 months

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Determine the effect of montelukast / moderate dose ICS versus high dose ICS on asthma control as measured by the asthma control questionnaire.

Outcome Time Frame:

September 2014

Safety Issue:

No

Authority:

United States: Institutional Review Board

Study ID:

Pro00018748

NCT ID:

NCT01016847

Start Date:

January 2010

Completion Date:

September 2014

Related Keywords:

  • Asthma
  • Asthma

Name

Location

Duke Asthma Allergy and Airway CenterDurham, North Carolina  27704