drugset / Trial / NCT00521222

Evaluating Long Acting Beta Agonists Used to Treat Asthma Among Those With Either Arg/Arg or Gly/Gly Genotypes

NCT00521222

Completed 90 enrolled Columbia University
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2007-06
Primary completion
2010-11
Completion
2010-11

Drugs

EvaluationDrugModalityDoseRoute
Comparator Fluticasone Other / unclassified 44 ug Inhaled
Comparator Fluticasone Other / unclassified 45 ug Inhaled
Comparator Fluticasone Other / unclassified 110 ug Inhaled
Comparator Fluticasone Other / unclassified 115 ug Inhaled
Comparator Fluticasone Other / unclassified 220 ug Inhaled
Comparator Fluticasone Other / unclassified 230 ug Inhaled
Comparator Salmeterol Other / unclassified 21 ug Inhaled
Background Ipratropium Small molecule Inhaled
Background Salbutamol Unknown Inhaled

Indications