Evaluating Long Acting Beta Agonists Used to Treat Asthma Among Those With Either Arg/Arg or Gly/Gly Genotypes
Information source: Columbia University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: Fluticasone with salmeterol (Drug); Fluticasone HFA (Drug)
Phase: N/A
Status: Active, not recruiting
Sponsored by: Columbia University Official(s) and/or principal investigator(s): Marjorie Slankard, M.D., Principal Investigator, Affiliation: Columbia University
Summary
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.
Clinical Details
Official title: Arg/Arg Genotype and Long Acting Beta Agonists in Asthma. Improved Quality of Care for Patients With Asthma.
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Absolute change in morning peak flow
Secondary outcome: Absolute and percentage change in rescue inhaler use
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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
Locations and Contacts
Hackensack University Medical Center, Hackensack, New Jersey 07601, United States
Columbia Presbyterian Medical Center, New York, New York 10032, United States
Columbia University Medical Center Eastside, New York, New York 10022, United States
Additional Information
Starting date: June 2007
Last updated: June 7, 2013
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