Medical tests

AQLQ is used to measure the physical, emotional, social and occupational problems for participants with asthma. There are 32 questions in 4 domains (symptoms, activity limitation, emotional function and environmental stimuli) to measure activity limitation and symptom frequency using a recall period of 2 weeks. Each 32 questions are on a 7-point scale (7 = not impaired at all and 1 = severely impaired). The overall AQLQ score is the mean of all 32 responses and the individual domain scores are the means of the items in those domains. Lower scores indicate worsening.

ACQ is used to evaluate asthma control, the full range of clinical impairment (well controlled to life threatening) for the participant with asthma. There are 7 questions (5 for symptoms \[night-time awakenings, morning symptoms, limitation of activities, shortness of breath, and wheezing\], use of daily rescue bronchodilator, and percent predicted forced expiratory volume value). All 7 items are scored on a 7-point scale (0 = good control, 6 = poor control), with the mean score as an overall summary score. The recall period is 7 days. Higher scores indicate worsening.

FEV1 will be measured by using spirometry test. Spirometry is used to measure lung function, specifically the volume and/or flow of air that can be inhaled and exhaled. Lung volumes will be measured according to the body temperature, pressure, and saturated standard convention using the spirometer. Pre-bronchodilator spirometry will be performed in the absence of albuterol/salbutamol or at least 6 hours after the last dose of albuterol/salbutamol and post- bronchodilator spirometry will be performed after 15 to 30 minutes administration of albuterol/salbutamol via metered-dose inhaler.

FVC will be measured by using spirometry test. Spirometry is used to measure lung function, specifically the volume and/or flow of air that can be inhaled and exhaled. Lung volumes will be measured according to the body temperature, pressure, and saturated standard convention using the spirometer. Pre-bronchodilator spirometry will be performed in the absence of albuterol/salbutamol or at least 6 hours after the last dose of albuterol/salbutamol and post- bronchodilator spirometry will be performed after 15 to 30 minutes administration of albuterol/salbutamol via metered-dose inhaler.

FEF is the flow of air coming out of the lung during the middle portion of a forced expiration. It is generally defined by what fraction remains of the forced vital capacity (FVC), usually 25-75 percent (FEF25-75%). Pre-bronchodilator spirometry will be performed in the absence of albuterol/salbutamol or at least 6 hours after the last dose of albuterol/salbutamol and post- bronchodilator spirometry will be performed after 15 to 30 minutes administration of albuterol/salbutamol via metered-dose inhaler.

PEER will be measures by using spirometry test. Spirometry is used to measure lung function, specifically the volume and/or flow of air that can be inhaled and exhaled. Lung volumes will be measured according to the body temperature, pressure, and saturated standard convention using the spirometer. Pre-bronchodilator spirometry will be performed in the absence of albuterol/salbutamol or at least 6 hours after the last dose of albuterol/salbutamol and post- bronchodilator spirometry will be performed after 15 to 30 minutes administration of albuterol/salbutamol via metered-dose inhaler.

Methacholine challenge test is used to assess airway reactivity in asthma. In this test, baseline spirometry for participant is measured by inhalation of increasing concentrations of aerosolized methacholine up to 16 mg/mL. The provocative dose (PC20) is defined as the dose of methacholine required to cause a greater than or equal to 20 percent decrease from the baseline forced expiratory volume in 1 second value. A PC20 result of less than or equal to 16 mg/mL will be considered to reflect increase airway responsiveness for fulfilling eligibility criteria.

Measurement of FENO is a quantitative, noninvasive, simple, and safe method of measuring airway inflammation that provides a complementary tool to assessing airways disease. The participant can exhale directly into a measurement device, or into a reservoir that can afterwards be connected to the analyzer. With the former technique, the early and later nitric oxide in the breath sample can be analyzed separately. Two replicate FENO measurements will be obtained that agree at the 10% level and up to a total of 8 measurements will be performed to achieve this level of agreement.

SGRQ-C is a 14-item questionnaire designed to measure health impairment in participants with COPD. The SGRQ-C has 2 parts. Part 1 generates the Symptoms score, and Part 2 generates the Activity and Impacts scores. Total score (0 to 100) is the sum of all scores. Higher scores indicate greater health impairment. Higher score indicate worsening.

E-RS is a 11 respiratory system items scoring algorithm to assess the severity of respiratory symptoms in participants with Chronic Obstructive Pulmonary Disease (COPD). Each item has either 5 or 6 response options. Higher score indicate more severe COPD.