Asthma Clinical Trial
Official title:
A Randomised, Multi-centre, Open Label, Cross-over Non-inferiority Study to Evaluate Efficacy, Safety and Tolerability of Neumoterol 400 and Symbicort Forte in Adults With Asthma
This Phase IV study is an a multi-centre, randomised open label, two way cross-over design to
evaluate the efficacy, safety, and tolerability of NEUMOTEROL 400 in subjects with asthma.
The study will be used to demonstrate the non-inferiority of Budesonide/Formoterol Fumarate
combination (BFF) 400/12 micrograms (mcg) single capsule inhaler (NEUMOTEROL 400) compared
with BFF 320/9 mcg SYMBICORT Forte TURBUHALER® inhaler.
The population for this study will be adult subjects (>=18 and <=80 years) with a diagnosis
of asthma who have a pre-bronchodilator forced expiratory volume in one second (FEV1) of 40%
to 85% of the predicted normal value, and are receiving a stable dose of inhaled
corticosteroid inhaled corticosteroid (ICS) with or without long-acting beta-adrenergic
agonist (LABA) prior to screening.
The study will consist of six phases: Prescreening, Screening/Run-in (4 weeks), Treatment
Period 1 (4 weeks), Washout (minimum 4 weeks), Treatment Period 2 (4 weeks) and Follow-up (1
week). The total duration of the study for each subject will be at least 17 weeks. There will
be up to 6 study visits and a follow-up telephone call.
Pre-screening Visit will allow subjects who had recent asthma medication changes to be
stabilized prior to Screening. During the run-in and wash-out periods, all the subjects will
receive budesonide dry powder inhaler (DPI) 400 mcg twice daily (BID) (NEUMOTEX™ 400) and
salbutamol 100mcg pressurized metered dose inhaler (pMDI) on demand, as rescue medication.
The dose of NEUMOTEROL 400 (400/12 mcg) and SYMBICORT Forte (320/9 mcg) will be one
inhalation BID, and each treatment will be given to all subjects for 4 weeks (with a 4-week
Washout Period between treatments).
The study will include 300 subjects for screening so that at least 210 will be randomised and
a minimum of 168 subjects complete the study/are evaluable. Half the subjects will be on
Regimen A in Treatment Period 1and will then be crossed over to Regimen B in Treatment Period
2, and vice versa. Regimen A: BFF (400/12 mcg) by single capsule inhaler. Regimen B: BFF
(320/9 mcg) TURBUHALER inhaler. The treatment periods will be separated by a washout Period
of 4 weeks.
NEUMOTEROL and NEUMOTEX are trademarks of the GSK group of companies SYMBICORT and TURBUHALER
are trademarks of AstraZeneca
n/a
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