CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 90 enrolled
Drug / intervention
Fluticasone with salmeterol +3 moredrug
Likely dose
Fluticasone with salmeterol 45mcgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00521222
NCT00521222N/ACompleted

Arg/Arg Genotype and Long Acting Beta Agonists in Asthma. Improved Quality of Care for Patients With Asthma.

Columbia University·interventional·Posted Aug 27, 2007·Updated Apr 21, 2023

In Brief

A clinical study evaluating Fluticasone with salmeterol, Fluticasone HFA, and 2 other interventions for Asthma. Completed, enrolled 90 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 27, 2007
Enrollment StartJun 1, 2007
Primary CompletionNov 1, 2010
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 18.8 years ago

Interventions

Fluticasone with salmeteroldrug

Fluticasone 45mcg, 115mcg, or 230mcg with salmeterol 21mcg, via HFA device, 2 puffs every 12 hrs, over 16 week study period.

Fluticasone HFAdrug

Fluticasone HFA alone at 44mcg, 110mcg or 220 mcg 2 puffs every 12 hrs, over 16 week study period.

Ipratropium HFAdrug

Primary as-needed rescue medication in all treatment groups

Albuterol HFAdrug

Secondary as-needed rescue medication in all treatment groups