The aim of this exploratory investigation is to evaluate if the Forced Expiratory Volume in the 1st second (FEV1) measurements, fractional exhaled nitric oxide (FENO) and Provocative Concentration 20 (PC20) after Adenosine Monophosphate (AMP) bronchial challenge evaluated after administration of a fixed combination of a Long-acting Beta-2-agonist (LABA) and an Inhaled Corticosteroid (ICS) at increasing doses may be suitable to demonstrate a dose response.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
18
pressurised metered dose inhaler, BDP + Formoterol 100/6 µg, 4 inhalations bid (total daily dose 800 µg BDP + 48 µg formoterol)
pressurised metered dose inhaler, BDP + Formoterol 100/6 µg, 1 inhalation bid (total daily dose 200 µg BDP + 12 µg formoterol)
pressurised metered dose inhaler
Respiratory Clinical Trials - Heart Lung Centre - Queen Anne Street Medical Centre
London, United Kingdom
PC20 after AMP challenge
Provocative Concentration of AMP causing a 20% fall in FEV1.
Time frame: 4 h post dose
Fractional Exhaled Nitric Oxide (FeNO)
Fractional exhaled nitric oxide (ppb). FeNO is a biomarker measured in a breath test and it is a validated method for measuring the airway inflammation in asthma.
Time frame: 4 h post dose
Lung function
FEV1 area under the curve from 0 to 4 hour post dose (AUC0-4h)
Time frame: from 0 to 4 h post dose
FENO
Fractional exhaled nitric oxide
Time frame: 2 h post dose
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.