A Phase IIA FF/VI Study to Measure FeNO in Asthmatic Patients.

Inclusion Criteria

• •Age of subject: Between 18 and 65 years of age inclusive, at the time of signing the informed consent.
• •A doctor diagnosis of asthma for at least 6 months prior to the start of the study.
• •Severity of disease: A screening pre-bronchodilator forced expiratory volume in one second (FEV1) \>=60% of predicted values, which will be based upon NHANES III
• •Reversibility of disease: Demonstrated presence of reversible airway disease at screening (repeat testing of eligibility can be undertaken following the screening visit up to Day -7) OR The presence of reversible airways disease can have been demonstrated historically within 6 months of the screening visit. Reversible airway disease is defined as increase in FEV1 of \>=12% over baseline and an absolute change of \>=200 mL within 30 minutes following 4 inhalations of albuterol/salbutamol inhalation aerosol/spacer (or equivalent nebulised treatment with albuterol/salbutamol solution).
• •Current Therapy: Short-acting beta2-agonists (SABA) prescribed for at least 12 weeks prior to screening. No inhaled corticosteroids (ICS), long-actint beta2-receptor agonist (LABA), long acting muscarinic anatagonist (LAMA), leukotriene receptor antagonist (LTRA) therapy for three months prior to the start of the study.
• •Non-smoker or ex-smoker (no smoking in previous 12 weeks, ≤10 pack years).
• •Screening and Day -7 AM fraction of inhaled nitric oxide (FeNO) values \> 40ppb. Both screening and Day -7 AM FeNO values for treatment Period 1 need to be \> 40ppb for the subject to be eligible.
• •Bodyweight and BMI: Bodyweight \>=50 kg and body mass index (BMI) within the range 18.0 40.0 kg/m2 (inclusive)
• •Male OR Female:
• •Females: A female subject is eligible to participate if she is not pregnant (as confirmed by a negative urine human chorionic gonadotrophin \[hCG\[ test), not lactating, and at least one of the following conditions applies: Non-reproductive potential defined as:
• •Pre-menopausal females reporting one of the following:
• •Tubal ligation Hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion Hysterectomy Bilateral Oophorectomy
• •Postmenopausal defined as 12 months of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous follicle stimulating hormone \[FSH\] and estradiol levels consistent with menopause \[refer to laboratory reference ranges for confirmatory levels\]). Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrolment.
• •Reproductive potential and agrees to follow one of the options listed in the Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential (FRP) from 30 days prior to the first dose of study medication and until after the last dose of study medication and completion of the follow-up visit
• •The investigator is responsible for ensuring that subjects understand how to properly use these methods of contraception.
• •Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the consent form and in this protocol.
• •Pregnancy and Lactating Females:
• •Pregnant females as determined by positive serum hCG test at screening or by positive urine hCG test prior to dosing.
• •Lactating females
• •Allergies:
• •Milk Protein Allergy: History of severe milk protein allergy.
• •Drug Allergy: Any adverse reaction including immediate or delayed hypersensitivity to any beta2-agonist, sympathomimetic drug, or any intranasal, inhaled, or systemic corticosteroid therapy. Known or suspected sensitivity to the constituents of the Dry Powder Inhaler (DPI) (i.e., lactose or magnesium stearate).
• •Historical Allergy: History of drug or other allergy that, in the opinion of investigator or GSK Medical Monitor, contraindicates their participation