Pharmacokinetics and PharmacoDynamics of GW685698 in Paedeatric Asthmatic Patients
Condition: Asthma
MeSH terms: Asthma
Intervention: Fluticasone furoate; Matching placebo
Intervention description: Novel dry powder inhaler: 100µg per blister One blister strip containing fluticasone furoate micronised drug blended with lactose and a second blister strip containing lactose and magnesium stearate.; Novel dry powder inhaler: One blister strip containing lactose and a second blister strip containing lactose and magnesium stearate.
Intervention MeSH terms: Fluticasone; Xhance
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 27.0
Sex: All
Minimum age: 5 Years
Maximum age: 11 Years
Healthy volunteers: No
Keywords: inhalation profiles; pharmacokinetics; pharyngometry; asthma; pediatric subjects; GW685698; Fluticasone furoate; safety

Summary:

      This study will investigate the effect of dosing with flutucasone furoate in asthmatic
      subjects aged 5-11 years of age. A randomized, two-way crossover, with placebo control, over
      a 14 day treatment period, it will investigate safety, tolerability, pharmacokinetics and
      serum cortisol levels.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and pre-menarchial female subjects aged 5-11 years on the last planned treatment
             day are eligible for this study. Pre-menarchial females are defined as any female who
             has yet to begin menses and is considered Tanner Stage 2 or less.

          -  Diagnosis of asthma at least 6 months prior to screening.

          -  Patients must be controlled on their existing asthma treatment at screening as defined
             by a Childhood Asthma Control Test score of >19 and PEF (Peak Expiratory Flow) ≥80%
             predicted.

          -  Apart from asthma, eczema and rhinitis, subjects should be healthy and suffer from no
             other significant medical conditions.

          -  Subjects must be taking a stable regimen of a short acting beta-agonist inhaler on an
             as-need basis for at least 4 weeks prior to screening.

          -  Subjects must weigh at least 15 kg (kilograms).

          -  Subjects must demonstrate ability to accept and effectively use the fluticasone
             furoate devices using the demonstration kits provided to the site.

          -  Subjects and parents/guardians must be able to understand and comply with protocol
             requirements, instructions and protocol-stated restrictions. Parents/guardians must
             have the ability to read, write and record diary information collected throughout the
             study. They must also have the ability to manage study drug administration and PEF
             assessments.

          -  A signed and dated written informed consent from at least one parent/guardian, and
             accompanying informed assent from the subject prior to admission to the study.

        Exclusion Criteria:

          -  Subjects who have changed their asthma medication within 4 weeks of screening or
             subjects currently being treated with inhaled corticosteroids or have received such
             treatment within 4 weeks of screening. In addition, subjects currently receiving (or
             have received within 4 weeks of screening) any of the following asthma therapies:
             theophyllines, long-acting inhaled beta-agonists or oral beta-agonists.

          -  Any medical condition or circumstance making the volunteer unsuitable for
             participation in the study (e.g. history of life-threatening asthma).

          -  Any clinically relevant abnormality identified on the screening medical assessment,
             including asthma exacerbation requiring systemic corticosteroids (oral, intramuscular,
             intravenous) or emergency room attendance within 3 months or asthma exacerbation
             requiring hospitalization within 6 months prior to screening.

          -  Culture-documented or suspected bacterial or viral infection of the upper or lower
             respiratory tract, sinus or middle ear that is not resolved within 4 weeks of
             screening and led to a change in asthma management or, in the opinion of the
             Investigator, is expected to affect the subject's asthma status or the subject's
             ability to participate in the study.

          -  Clinical visual evidence of oral candidiasis at screening.

          -  Parent/guardian has history of psychiatric disease, intellectual deficiency, substance
             abuse, or other condition (e.g., inability to read, comprehend and write) which will
             limit the validity of consent to participate in this study.

          -  Any adverse reaction including immediate or delayed hypersensitivity to any
             beta-2-agonist, sympathomimetic drug, or any intranasal, inhaled or systemic
             corticosteroid therapy.

          -  Known or suspected sensitivity to the constituents of the novel dry powder inhaler
             (i.e., lactose or magnesium stearate), for example, history of severe milk protein
             allergy.

          -  A subject will not be eligible for this study if he/she is an immediate family member
             of the participating Investigator, sub-Investigator, study coordinator, or employee of
             the participating Investigator.

          -  Children who are wards of the state or government.

          -  Evidence of clinically significant abnormality in the 12-lead ECG (electrocardiogram)
             at screening.