Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
GlaxoSmithKline
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
Age: 18 years of age or older
Non-, former or current smokers with a documented smoking history of ≤ 10 pack years
Asthma diagnosis as defined by the National Institutes of Health
Best FEV1 of 50% to \<80% of the predicted normal value
For current and former smokers, a post-albuterol FEV1/FVC ratio of \>0.70 at Visit 1/1a (between 5:00AM and 12:00 noon)
≥ 12% and ≥200mL reversibility of FEV1
Must have been using FP/SAL 250/50mcg inhalation powder BID for at least 2 weeks just prior to Visit 1.
Must be able to replace their current short-acting beta2-agonists with albuterol inhalation aerosol
Must be able and willing to give written informed consent to take part in the study.
Must be able and willing to comply with all aspects of the study including completion of daily e-Diary.
You may not be if
History of life-threatening asthma
Recent asthma exacerbation
Concurrent respiratory disease
Recent respiratory infection
Liver disease
Other concurrent diseases/abnormalities
Oral candidiasis
Drug allergy
Milk protein allergy
Immunosuppressive Medications
Administration of systemic, oral or depot corticosteroids within 12 weeks of Visit 1
OATP1B1 substrates within 4 weeks of Visit 1
Cytochrome P450 3A4 (CYP 3A4) Inhibitors
Cytochrome P450 3A4 (CYP 3A4) Inducers
Investigational Medications
Compliance: any infirmity, disability, or geographical location which seems likely (in the opinion of the Investigator) to impair compliance with any aspect of this study protocol
Affiliation with Investigator's Site
Clareo Health | Safety and Efficacy Study Adding GSK2190915 to Mid-dose Inhaled Corticosteroid/Long Acting Beta Agonist Combination Treatment for Asthma
