Sub-Sensitivity to Long-Acting Bronchodilators (LABA)

Study Overview
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Brief Summary
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The purpose of this study is to look at whether Advair® and SYMBICORT® have different effects on airway constriction by means of methacholine challenge testing.

Official Title
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Sub-Sensitivity to Long-Acting Bronchodilators (LABA)

Conditions
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Asthma

Intervention / Treatment
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* Drug: fluticasone propionate and salmeterol
* Drug: budesonide and formoterol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 20 subjects males or females 18-65 years of age with physician diagnosed asthma Diagnosis of asthma > 12 months Currently on 2 puffs SABA bid. Baseline percent FEV1 of greater than 60% and less than or equal to 100% 12% reversibility in the previous 12 months 12% reversibility at Screening Visit Positive MTC (≤ 8mg/ml) at the end of 2 week Run-In Currently symptomatic with ACT score less than 19 at the end of run in on ICS ≥ 200 and ≤ 400 ug/day Non-smoker or ex-smoker with < 10 pk year who stopped > 1 year ago Exclusion Criteria: Asthma exacerbation, significant airflow obstruction, or respiratory infection between Visits 0 and 2. Patients who fail screening because of one of these events may be re-screened once (at least 4 weeks after recovery from the event). Pre-existing lung disease other than asthma, including active infections Clinically significant medical disease that is uncontrolled despite treatment or is likely in the opinion of the investigator to require a change in therapy during the study Noncompliance or inability to participate in all assessments. Current smoker or former smoker with a lifetime smoking history of ≥ 10 pack-years. A current smoker is defined as someone who has smoked one or more cigarettes per day (or marijuana or a pipe or cigar) for >/= 30 days within the 24 months prior to Visit 1. Any individual who smokes (cigarettes, marijuana, pipe, or cigar) occasionally, even if for < 30 days in the 24 months Prior to Visit 1, must agree to abstain from all smoking from the time of consent through completion. History of substance abuse that may impair or risk the patient's full participation in the study, in the judgment of the investigator. Participation in another interventional clinical trial (including a trial of an approved drug or an interventional study that does not include medication) within 30 days or 5 half-lives of the investigational agent, whichever is longer. Women with a positive urine pregnancy test.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: fluticasone propionate and salmeterol<br> | Drug: fluticasone propionate and salmeterol<br>* 45/4.5 two puffs twice daily<br>* Other names: Advair;Drug: budesonide and formoterol<br>* 80/4.5 two puffs twice daily<br>* Other names: Symbicort;|
| Active Comparator: budesonide and formoterol<br> | Drug: fluticasone propionate and salmeterol<br>* 45/4.5 two puffs twice daily<br>* Other names: Advair;Drug: budesonide and formoterol<br>* 80/4.5 two puffs twice daily<br>* Other names: Symbicort;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in PC20 | Improvements in PC20 as measured by methacholine challenge between the two treatment groups at the end of the first 4 week period to determine efficacy between low dose Advair and Symbicort. | Study Completion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in FEV1 | Changes in peak pre-bronchodilator FEV1 [measured at hours 10, 11, 12 post evening dose] over the four week treatment periods and over each 12 hour dosing period (pre evening dose FEV1). | Study Completion |