Asthma Clinical Trial
Official title:
A Double-blind, Randomised, Incomplete Block, Crossover, Placebo-controlled, Dose-response Study to Assess Bronchial Hyperresponsiveness and Airway Inflammation Effects of FlutiForm® pMDI Low and High Dose in Adult Subjects With Mild to Moderate Asthma
This is a dose-response study to determine how various measurements of airway inflammation respond to high and low dose FlutiForm®, and compared to placebo.
The study consists of two 4-week treatment periods, each preceded by a 14-21 wash-out period.
Subjects will be randomised to receive two of the three study treatments - FlutiForm® pMDI
50/5 µg, FlutiForm® pMDI 250/10 µg, or placebo (dummy inhaler). During the wash-out periods,
subjects will take only salbutamol, if required, as rescue medication.
Subjects will record a daily diary for PEFR, study medication use, rescue medication use,
asthma symptom scores, and sleep disturbance due to asthma. Assessments performed at study
clinic visits include inhaled adenosine 5'-monophosphate (AMP) challenge test, induced sputum
test, exhaled nitric oxide (eNO) test, and spirometry tests. Safety will be assessed by lab
tests, vital signs, ECG and adverse events.
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