Asthma
Conditions
Keywords
asthma exacerbation, asthma
Brief summary
This study will last up to 62 weeks. You will visit the clinic up to 17 times. Certain clinic visits will include physical examination, medical history review and lung function tests. The purpose of this study is to see if one asthma drug (fluticasone propionate/salmeterol) is better in reducing the number of asthma exacerbations compared with another drug (fluticasone propionate alone)
Interventions
DRUGfluticasone propionate/salmeterol powder
DRUGfluticasone propionate powder
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
12 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* History of asthma for at least 6 months. * Taking a low-dose of an inhaled corticosteroid for at least one month prior to the study (such as fluticasone propionate or budesonide).
Exclusion criteria
* History of life-threatening asthma. * Hospitalized for asthma within 3 months prior to the study. * Current respiratory tract infection. * Will not be able to attend clinic visits for the entire length of the study. * Certain medical conditions that will make being in the study unsafe (such as congestive heart failure, uncontrolled hypertension, tuberculosis or certain drug allergies).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Asthma exacerbation rate per patient per year | — |
Secondary
| Measure | Time frame |
|---|---|
| Morning peak flow measurement, percent of asthma symptom-free days, percent of albuterol-free days | — |
Countries
United States
Outcome results
None listed