Research Studies

AGE 1. 18 years of age or older at the time of signing the informed consent. TYPE OF SUBJECT AND DIAGNOSIS INCLUDING DISEASE SEVERITY 2. Diagnosis: Subjects with a diagnosis of asthma as defined by the National Institutes of Health [NIH 2007] at least one year prior to Visit 0. 3. Symptomatic: Subjects with inadequately controlled asthma (ACQ-6 score ≥1.5) despite ICS/LABA maintenance therapy at Visit 1.

18 years of age or older at the time of signing the informed consent. 2. Diagnosis: Subjects with a diagnosis of asthma as defined by the National Institutes of Health [NIH 2007] at least one year prior to Visit 0. 3. Symptomatic: Subjects with inadequately controlled asthma (ACQ-6 score ≥1.5) despite ICS/LABA maintenance therapy at Visit 1. 4. Asthma Control: Note: please refer to the SRM for guidance on the following: In the 1 year prior to Visit 1:  A documented healthcare contact for acute asthma symptoms OR  A documented temporary change in asthma therapy for acute asthma symptoms, according to a pre-specified asthma action plan (or equivalent) 5. Current Asthma Maintenance Therapy: Subjects are eligible if they have required daily ICS/LABA for at least 12 weeks prior to Visit 0 with no changes to maintenance asthma medications during the 6 weeks immediately prior to Visit 0 (including no changes to a stable total dose of ICS of >250 mcg/day fluticasone proprionate [FP, or equivalent]). Examples of acceptable doses of commonly prescribed ICS medication are provided in the GINA guidelines [GINA 2016], [BTS/SIGN 2016], [Japanese guidelines for adult asthma 2017]. Dosing regimen (once or twice daily to equal the total daily dose) should be restricted to the current local product labels/treatment guidelines. 6. Spirometry: A best pre-bronchodilator morning (AM) FEV1 ≥30% and <85% of the predicted normal value at Visit 1. Predicted values will be based upon the European Respiratory Society (ERS) Global Lung Function Initiative [Quanjer 2012]. 7. Reversibility of Disease: airway reversibility defined as ≥12% and ≥200 mL increase in FEV1 between 20 and 60 minutes following 4 inhalations of albuterol/salbutamol aerosol at Visit 1. Note: If the subject does not meet the above reversibility criteria at Visit 1 then the reversibility assessment may be repeated once within 7 days of Visit 1 if either criteria a) or b) are met: 2016N271022_05 CONFIDENTIAL 205715 39 a) ≥9% increase in FEV1 between 20 and 60 minutes following 4 inhalations of albuterol/salbutamol aerosol at Visit 1. b) Documented evidence of a reversibility assessment within 1 year prior to Visit 1 which demonstrated a post-bronchodilator increase in FEV1 of ≥12% and ≥200 mL. Should the subject successfully demonstrate airway reversibility (defined as ≥12% and ≥200 mL increase in FEV1 between 20 and 60 minutes following 4 inhalations of albuterol/salbutamol aerosol) at the second attempt then, provided that all other eligibility criteria assessed at Visit 1 are met, the subject may enter the 3-week runin period (see Section 7.3.4.1). 8. Short-Acting β2 Agonists (SABAs): All subjects must be able to replace their current SABA inhaler with albuterol/salbutamol aerosol inhaler at Visit 1 as needed for the duration of the study. Subjects must be judged capable of withholding albuterol/salbutamol for at least 6 hours prior to study visits.