Asthma Clinical Trial
Official title:
An Open-label, Randomised, Replicate, Six-way Crossover, Single Dose Study to Determine the Bioequivalence of Fluticasone Furoate (FF) Inhalation Powder (Single Strip Configuration) Compared With FF Inhalation Powder (Two Strip Configuration) and Compared With FF / Vilanterol (VI) Inhalation Powder Administered Via the Novel Dry Powder Inhaler.
The purpose of this study is to determine the bioequivalence of fluticasone furoate (FF) inhalation powder (single strip configuration) compared with FF inhalation powder (two strip configuration) and compared with FF / vilanterol (VI) inhalation powder. Fluticasone furoate (FF), is being developed both as a monotherapy for the treatment of asthma and in combination with vilanterol (VI) for the treatment of asthma and Chronic Obstructive Pulmonary Disease (COPD). Thirty healthy male and female subjects will be enrolled in the study to ensure twenty-four evaluable subjects.
Fluticasone furoate (FF; GW685698), a novel corticosteroid, is being developed both as a
monotherapy for the treatment of asthma and in combination with vilanterol (VI; GW642444)
for the treatment of asthma and COPD. The novel dry powder inhaler (NDPI) will be used to
deliver both FF monotherapy and the FF/VI combination. The NDPI can be used with either a
single strip or two strips, the single strip being used for FF monotherapy and two strips
being used to deliver the FF/VI combination. In some previous FF monotherapy studies,
including the phase IIB programme, conducted using the NDPI, the inhaler contained two
strips (FF in the first strip and matched VI placebo in the second strip). This two strip
configuration has been used for the majority of FF monotherapy treatment arms in previous
and ongoing studies. The aim of this study is to determine the bioequivalence of FF
monotherapy (single strip) compared with FF monotherapy (two strip), and to determine the
bioequivalence of FF monotherapy (single strip) compared with FF/VI, administered via the
NDPI. This data will facilitate the inclusion of FF monotherapy (two strip) data and FF/VI
combination data to support the FF monotherapy product development. This will be a
randomised, open-label, replicate, six-way crossover, single dose study in healthy male and
female subjects. Thirty healthy male and female subjects will be enrolled in this study to
ensure twenty-four evaluable subjects.
Pharmacokinetic samples will be taken over 36 hours. Safety will be assessed by adverse
event (AE) monitoring throughout the study.
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