Pharmacokinetics and Pharacodynamics of GW642444 in Paedetric Subjects
Condition: Asthma
MeSH terms: Asthma
Intervention: GW642444; Placebo
Intervention description: GW642444 25 μg; Novel dry powder inhaler; Matching placebo; Novel dry powder inhaler
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 28.0
Sex: All
Minimum age: 5 Years
Maximum age: 11 Years
Healthy volunteers: No
Keywords: Asthma; Tolerability; Safety; Pharmacokinetics; GW642444

Summary:

      This study will investigate the effect of dosing paedeatric asthmatic subjects with GW642444,
      an orally inhaled long-acting agonist of the β2-adrenoceptor.
    

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) >75 %
             predicted.

          -  Subjects must be taking a stable regimen of fluticasone propionate (≤200 μg
             (micrograms) twice daily or equivalent) and short acting beta-agonist inhaler on an
             as-need basis for at least 4 weeks prior to screening.

          -  Apart from asthma, eczema and rhinitis, subjects should be healthy and suffer from no
             other significant medical conditions.

          -  Subjects must weigh at least 15 kg (kilograms).

          -  Subjects must demonstrate ability to accept and effectively use the GW642444 device
             using the demonstration kits provided to the site.

          -  The subject and parent or guardian are able to understand and comply with protocol
             requirements, instructions, and protocol-stated restrictions. The parent or guardian
             must have the ability to read, write and record diary information collected throughout
             the study. The parent or guardian must also have the ability to manage study drug
             administration and PEF assessments.

          -  At least one parent or guardian has signed and dated the written informed consent
             prior to admission to the study. This will be accompanied by informed assent from the
             subject.

        Exclusion Criteria:

          -  Subjects currently receiving (or have received within 4 weeks of screening) any of the
             following asthma therapies: theophyllines, long-acting inhaled beta-agonists, oral
             beta-agonist.

          -  Subjects who have changed their asthma medication within 4 weeks of screening.

          -  Clinical visual evidence of oral candidiasis at screening.

          -  Any clinically relevant abnormality identified on the screening medical assessment

          -  Any medical condition or circumstance making the subject unsuitable for participation
             in the study (e.g. history of life-threatening asthma)

          -  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 the screening visit.

          -  Culture-documented or suspected bacterial or viral infection of the upper or lower
             respiratory tract which is not resolved within 4 weeks of the screening visit.

          -  Any adverse reaction including immediate or delayed hypersensitivity to any
             betaagonist 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.

          -  The parent or guardian has history of psychiatric disease, intellectual deficiency,
             substance abuse, or other condition (e.g., inability to read, comprehend or write)
             which will limit the validity of consent to participate in this study.

          -  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