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| Tracking Information | |||||||||
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| First Received Date ICMJE | August 24, 2007 | ||||||||
| Last Updated Date | August 14, 2008 | ||||||||
| Start Date ICMJE | June 2007 | ||||||||
| Estimated Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Primary outcome measure will be absolute change in morning peak flow at the end of the 16-week study period compared with baseline (last two weeks of run-in). [ Time Frame: Outcome will be assessed at the end of the 16-week study period. ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00521222 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Absolute and percentage change in rescue inhaler use. [ Time Frame: Outcome wil be assessed at the end of the 16 week study period. ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Evaluating Long Acting Beta Agonists Used to Treat Asthma Among Those With Either Arg/Arg or Gly/Gly Genotypes | ||||||||
| Official Title ICMJE | Arg/Arg Genotype and Long Acting Beta Agonists in Asthma. Improved Quality of Care for Patients With Asthma. | ||||||||
| Brief Summary | We are conducting a study of asthma patients who use 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 Advair or substituting Advair 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 Flovent, the other to use Advair, 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. We 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. |
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| 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 Proventil, a short acting b2 agonist, is replaced with a different class of bronchodilator. We 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 Atrovent-HFA (a bronchodilator which works through a different mechanism) for rescue therapy; Proventil-HFA 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. |
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| Study Phase | |||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study | ||||||||
| Condition ICMJE | Asthma | ||||||||
| Intervention ICMJE | Drug: fluticasone with salmeterol or fluticasone alone | ||||||||
| Study Arms / Comparison Groups |
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| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 100 | ||||||||
| Estimated Completion Date | December 2009 | ||||||||
| Estimated Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00521222 | ||||||||
| Responsible Party | Marjorie Slankard, M.D., Columbia University | ||||||||
| Study ID Numbers ICMJE | AAAC1135 | ||||||||
| Study Sponsor ICMJE | Columbia University | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | Columbia University | ||||||||
| Verification Date | August 2008 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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