A Study of a New Asthma Medicine in Asthmatics Whose Asthma Worsens With Exercise
A Study of a New Asthma Medicine in Asthmatics Whose Asthma Worsens With Exercise
The primary objective of this study is to demonstrate that the combination of inhaled
 fluticasone furoate/vilanterol (100 mcg/25 mcg) once daily provides superior protection
 throughout the day against bronchoconstriction induced by exercise compared with fluticasone
 propionate 250 mcg twice daily in adolescent and adult subjects aged 12 to 50 diagnosed with
 persistent asthma.
Inclusion Criteria:

 -  Outpatient male or female 12 to 50 years of age

 -  Females of child-bearing potential must be willing to use birth control or commit to
 abstinence during the study

 -  Diagnosis of persistent asthma for at least 6 months

 -  Best pre-bronchodilator FEV1 of at least 70%.

 -  Current use of a low- to moderate-dose inhaled corticosteroid

 -  Ability to withhold albuterol 6 hours prior to visits.

 -  Physically able to perform exercise testing on a treadmill when albuterol has been
 withheld

 Exclusion Criteria:

 -  Intermittent asthma, seasonal asthma, or exercise-induced asthma only

 -  Symptomatic allergic rhinitis and/or thrush

 -  Abnormal, clinically significant electrocardigraph

 -  Respiratory infection within 4 weeks of first visit leading to asthma medication
 change or could affect subjects's asthma status or participation

 -  Asthma exacerbation within 12 weeks of first visit

 -  Respiratory diseases or other concurrent disease that would put subject at risk or
 confound results interpretation

 -  Investigational medicines within 30 days of first visit or less than five half-lives
 of medication in prior study

 -  Allergy to study drugs or study drug excipients

 -  Concomitant medications that could interact with study medications or affect the
 course of asthma

 -  Tobacco use within last year and/or a 10 pack-years history

 -  Inability to comply with requirements of the study

 -  Affiliation with investigator's site (example: family member)