Clinical Study to Evaluate the Efficacy of VR506 Using a New Inhaler for the Treatment of Asthma

Inclusion Criteria

• Written informed consent
• Adolescents aged 12 to 17 years (inclusive) and adults aged 18 to 65 years (inclusive)
• Documented clinical history of asthma (i.e. made by a physician) for at least 6 months before the Screening Visit
• Documented asthma reversibility in the 5 years prior to or during Screening, or if the asthma reversibility criterion is not met at Screening, then a repeat test may be carried out at the end of the Run-In Period
• Subjects with asthma who, in the opinion of the investigator, require maintenance therapy with inhaled corticosteroids (ICS), are believed to have been regularly compliant with this therapy, and are therefore likely to deteriorate within 6 weeks following withdrawal of their usual ICS treatment
• Mild or moderate asthma, defined as:
• Mild - good asthma control achieved by low-dose inhaled corticosteroid (daily dose 200-500 μg beclomethasone dipropionate or equivalent) with or without other low-intensity treatment (e.g. leukotriene modifiers or cromones) for at least 28 days before the Screening Visit
• Moderate - good asthma control achieved by low- to moderate-dose ICS (daily dose 200-1000 μg beclomethasone dipropionate or equivalent), and long acting β2-agonist (LABA) or other extra treatment, for at least 28 days before the Screening Visit
• Ability to use the new inhaler correctly, based on investigator's review of the completed inhaler operation checklist
• Ability to use the eDiary correctly, assessed by the investigator during the Screening Period
• Ability to perform technically satisfactory pulmonary function tests
• Ability to comply with study procedures, including blood sampling
• Body mass index (BMI) of 16.0 to 26.0 kg/m2 in adolescents, and in adult subjects recruited in the Philippines, and 18.0 to 32.0 kg/m2 in adults recruited in other countries
• Available to complete all study visits
• Oral peak inspiratory flow (PIF) of at least 60 L/min; using an appropriate device set to match the resistance of the new dry powder inhaler (nDPI)
• Good health, except for the presence of asthma, according to medical history and physical examination
• Normal (i.e. non-clinically significant abnormality) 12-lead electrocardiogram (ECG)
• Negative drug, alcohol, and urine cotinine screen; subjects must test negative for amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, cotinine (unless related to nicotine-containing therapies), ethanol, and opiates (unless given as a prescription medicine)
• Non-smokers or ex-smokers with a smoking history of less than 10 pack-years (e.g. 40%) in peak expiratory flow (PEF) between morning and evening measurements despite moderate to high doses of ICS, or are prone to acute, severe and often unpredictable attacks of asthma that may be fatal, on a background of apparently good asthma control
• History or current diagnosis of human immunodeficiency virus (HIV) infection
• Active chronic hepatitis B or C infection. If the patient's screening test is positive for hepatitis B surface antigen, the patient should be excluded unless the investigator, after a careful review of the patient's medical history and current laboratory tests of liver function, can exclude the possibility of recent or current infection
• Persistent arterial hypotension, with average systolic blood pressure (SBP) readings of ≤95 mmHg
• Subjects who have any clinically significant abnormality or finding from examination, tests, or history that may compromise subject safety, specifically any history of cardiac, renal or hepatic impairment
• Subjects with an abnormal ECG
• Persistent elevation of blood pressure, with average SBP readings of ≥160 mmHg or average diastolic blood pressure (DBP) readings of ≥100 mmHg
• Pregnant or lactating females
• Participation in another clinical study in the 28 days prior to the Screening Visit
• Current or a history of drug or alcohol abuse or dependence according to World Health Organization criteria in the 12 mon