Asthma
Conditions
Interventions
Trade Name: Fiboflapon
Pharmaceutical Form: Inhalation powder
Sponsors
GlaxoSmithKline Research & Development
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age: 12 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 0.70 at Visit 1/1a (between 5:00AM and 12:00 noon) - = 12% and =200mL reversibility of FEV1 - Must have been using FP 100mcg 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. Are the trial subjects under 18? yes Number of subjects for this age range: 41 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 290 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the efficacy and safety of adding GSK2190915 100mg, GSK2190915 300mg or placebo tablets administered once daily to fluticasone propionate 100mcg inhalation administered twice daily in uncontrolled asthmatic subjects > or = 12 years of age over the course of 6 weeks treatment.;Secondary Objective: The secondary objectives are to undertake an exploratory analysis of the efficacy and safety of adding montelukast 10mg administered once daily or salmeterol 50mcg administered twice daily to fluticasone propionate 100mcg inhalation administered twice daily and to investigate the pharmacokinetics and pharmacodynamics of GSK2190915 in uncontrolled asthmatic subjects > or = 12 years of age over the course of 6 weeks treatment. ;Primary end point(s): The primary efficacy endpoint was trough (AM pre-dose and pre-rescue bronchodilator) forced expiratory volume in 1 second (FEV1) at the end of the 6-week treatment period.;Timepoint(s) of evaluation of this end point: 6 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary efficacy endpoints comprised daily trough (AM pre-dose and pre-rescue bronchodilator) peak expiratory flow (PEF), daily PM PEF, daily asthma symptom score and daily rescue salbutamol use averaged over the last 3 weeks of the 6-week treatment period, percentage of symptom-free days and nights, rescue-free days and nights, nights without awakenings due to asthma and proportion of subjects withdrawn due to lack of efficacy during the last 3 weeks of the 6-week treatment period. Other secondary endpoints were mean change from baseline in Asthma Control Questionnaire (ACQ-6) and Asthma Quality of Life Questionnaire (AQLQ12+) scores. Safety endpoints comprised adverse events (AEs), haematology, chemistry (including liver function tests) and urinalysis parameters, physical examination, and vital signs (pulse rate and systolic and diastolic blood pressure).;Timepoint(s) of evaluation of this end point: 6 weeks | — |
Countries
United States
Contacts
Public ContactGSK Clinical Support Help Desk
GlaxoSmithKline Research & Development Ltd.
Outcome results
None listed