Arg/Arg Genotype and Long Acting Beta Agonists in Asthma. Improved Quality of Care for Patients With Asthma.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 3
- 主要终点
- Absolute Change in Morning Peak Flow
研究概览
简要总结
The investigators are conducting a study of asthma patients who use fluticasone with salmeterol (Advair) or any other combination of an inhaled corticosteroid (ICS) and a long acting beta agonist (LABA) to manage their asthma symptoms.
Participants begin the study by continuing to use fluticasone with salmeterol or substituting fluticasone with salmeterol for their current ICS/LABA medication at their regular dose or the comparable dose(all study medications are provided) for a six-week period. Patients are then separated into 2 groups: one group is asked to use fluticasone (Flovent), the other to use fluticasone with salmeterol , twice daily over a 16-week period (patients will need to be seen monthly during this time). Neither study personnel nor patients will know which drug is being used.
Patients are also asked to use a peak flow meter and record their daily results on a form, along with the number of puffs they use of their rescue inhaler each day. They also record any changes in asthma medications and information on any asthma episodes.
The investigators hypothesize that there are certain patients with asthma who will do better when a long acting beta agonist is removed from their maintenance asthma medications.
详细描述
Beta 2 (b2) agonists are the most common type of bronchodilator used to treat asthma. Beta 2 (b2) agonists are agents that bind to b2 receptors and cause muscle relaxation of the airways. There are different variants of the gene (genotypes) that influence how b2 agonists perform among the population.
A recent study demonstrated that patients with mild asthma and the Arg/Arg variant at the 16th amino acid position have improved lung function and asthma control when albuterol (Proventil-HFA), a short acting b2 agonist, is replaced with a different class of bronchodilator. The investigators plan to study asthma patients with distinct genetic makeups of the b2 receptor; specifically Arg/Arg and Gly/Gly.
Throughout the treatment period, patients will be instructed to use ipratropium bromide (Atrovent-HFA), a bronchodilator which works through a different mechanism for rescue therapy; albuterol will be available for use if necessary.
The goal of this study is to determine if the withdrawal of a beta 2 agonist leads to improved asthma control in those asthmatic patients with the Arg/Arg genotype compared with those with the Gly/Gly genotype.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older
- •History of moderate or severe and persistent asthma
- •Currently being treated with a long acting beta agonist and inhaled corticosteroid
- •Forced expiratory volume at one second (FEV1) > or = 70% at randomization visit (pulmonary function test result)
- •Women of childbearing potential must be on an effective form of contraception
- •Ability to read and understand English
排除标准
- •Active smoking or greater than 10-pack-year history of smoking
- •History of intubation for asthma within the past 10 years
- •Patients who are pregnant, become pregnant during the study or are breast feeding
- •Major comorbidity including: severe cardiac disease, uncontrolled hypertension, poorly controlled diabetes, malignancy within the past 5 years (except non-melanoma skin lesions), and pulmonary disease other than asthma
研究组 & 干预措施
Arg/Arg genotype on Advair (Fluticasone with Salmeterol) HFA
Asthma patients with the Arg/Arg genotype who are randomized to continue the combination therapy of a specific long-acting beta 2 agonist (salmeterol) and inhaled corticosteroid (fluticasone) in the form of Advair HFA.
干预措施: Fluticasone with salmeterol (Drug)
Arg/Arg genotype on Advair (Fluticasone with Salmeterol) HFA
Asthma patients with the Arg/Arg genotype who are randomized to continue the combination therapy of a specific long-acting beta 2 agonist (salmeterol) and inhaled corticosteroid (fluticasone) in the form of Advair HFA.
干预措施: Ipratropium HFA (Drug)
Arg/Arg genotype on Advair (Fluticasone with Salmeterol) HFA
Asthma patients with the Arg/Arg genotype who are randomized to continue the combination therapy of a specific long-acting beta 2 agonist (salmeterol) and inhaled corticosteroid (fluticasone) in the form of Advair HFA.
干预措施: Albuterol HFA (Drug)
Gly/Gly genotype on Advair (Fluticasone with Salmeterol) HFA
Asthma patients with the Gly/Gly genotype who are randomized to continue the combination therapy of a specific long-acting beta 2 agonist (salmeterol) and inhaled corticosteroid (fluticasone) in the form of Advair HFA.
干预措施: Fluticasone with salmeterol (Drug)
Gly/Gly genotype on Advair (Fluticasone with Salmeterol) HFA
Asthma patients with the Gly/Gly genotype who are randomized to continue the combination therapy of a specific long-acting beta 2 agonist (salmeterol) and inhaled corticosteroid (fluticasone) in the form of Advair HFA.
干预措施: Ipratropium HFA (Drug)
Gly/Gly genotype on Advair (Fluticasone with Salmeterol) HFA
Asthma patients with the Gly/Gly genotype who are randomized to continue the combination therapy of a specific long-acting beta 2 agonist (salmeterol) and inhaled corticosteroid (fluticasone) in the form of Advair HFA.
干预措施: Albuterol HFA (Drug)
Arg/Arg genotype on Fluticasone HFA
Asthma patients with the Arg/Arg genotype who are randomized to fluticasone (Flovent HFA) alone.
干预措施: Fluticasone HFA (Drug)
Arg/Arg genotype on Fluticasone HFA
Asthma patients with the Arg/Arg genotype who are randomized to fluticasone (Flovent HFA) alone.
干预措施: Ipratropium HFA (Drug)
Arg/Arg genotype on Fluticasone HFA
Asthma patients with the Arg/Arg genotype who are randomized to fluticasone (Flovent HFA) alone.
干预措施: Albuterol HFA (Drug)
Gly/Gly genotype on Fluticasone HFA
Asthma patients with the Gly/Gly genotype who are randomized to fluticasone (Flovent HFA) alone.
干预措施: Fluticasone HFA (Drug)
Gly/Gly genotype on Fluticasone HFA
Asthma patients with the Gly/Gly genotype who are randomized to fluticasone (Flovent HFA) alone.
干预措施: Ipratropium HFA (Drug)
Gly/Gly genotype on Fluticasone HFA
Asthma patients with the Gly/Gly genotype who are randomized to fluticasone (Flovent HFA) alone.
干预措施: Albuterol HFA (Drug)
结局指标
主要结局
Absolute Change in Morning Peak Flow
时间窗: Up to 16 weeks from baseline
Absolute change in morning peak flow at the end of the 16-week study period compared with baseline (last two weeks of run-in). Peak flow measurement is a test to measure air flowing out of the lung.
次要结局
- Change in Forced Expiratory Volume in 1 Second (FEV1) Pre-Bronchodilator(Up to 16 weeks from baseline)
- Change in Asthma Symptom Score(Up to 16 weeks from baseline)
- Change in Forced Expiratory Volume in 1 Second (FEV1) Post-Bronchodilator(Up to 16 weeks from baseline)
- Change in Forced Expiratory Volume in 1 Second (FEV1) Percent Predicted Pre-Bronchodilator(Up to 16 weeks from baseline)