Study Evaluating the Effect of IMA-638 in Subjects With Persistent Asthma

The PEFR is a participant's maximum speed of expiration, as measured with a peak flow meter. All participants were issued with the peak flow meter and instructed to perform the activity in triplicate in the morning prior to taking bronchodilator. The best among the 3 readings was selected.

The PEFR is a participant's maximum speed of expiration, as measured with a peak flow meter. All participants were issued with the peak flow meter and instructed to perform the activity in triplicate in the morning prior to taking bronchodilator. The best among the 3 readings was selected.

FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FEV1 was obtained from spirometry, performed before study treatment administration. Participants performed the test in triplicate at each visit and the best of the 3 values was selected.

FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FEV1 was obtained from spirometry, performed before study treatment administration. Participants performed the test in triplicate at each visit and the best of the 3 values was selected.

Airway hyper-reactivity was assessed using provocative concentration 20 (PC20). PC20 was the concentration of methacholine at which participants had 20 percent (%) decrease in FEV1. Results for PC20 were summarized together for all participants who received any dose of IMA-638 and for all participants who received placebo during any stage of the study as per investigator's discretion.

ACQ-5 was a 5-item participant-reported questionnaire assessing asthma symptoms (night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing). Participants were asked to recall how their asthma had been during the previous week. Questions were weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ score was the mean of the responses. Mean scores of less than or equal to (=<) 0.75 indicate well-controlled asthma, scores between 0.76 and less than (<) 1.5 indicate partly controlled asthma, and a score greater than or equal to (>=) 1.5 indicates uncontrolled asthma. Individual changes of at least 0.5 are considered to be clinically meaningful.

ACQ-5 was a 5-item participant-reported questionnaire assessing asthma symptoms (night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing). Participants were asked to recall how their asthma had been during the previous week. Questions were weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ score was the mean of the responses. Mean scores of =< 0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score >= 1.5 indicates uncontrolled asthma. Individual changes of at least 0.5 are considered to be clinically meaningful.

The rescue medication taken for needed symptoms was a short acting beta agonist (SABA) inhaler. Albuterol, 90 microgram (mcg)/puff, was recommended for use.

The rescue medication taken for needed symptoms was a SABA inhaler. Albuterol, 90 mcg/puff, was recommended for use.

FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.

FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.

FEF25-75 is the average expiratory flow over the middle half of the FVC. FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.

FEF25-75 is the average expiratory flow over the middle half of the FVC. FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.

Log 10-transformed serum total IgE levels were expressed in Log-10 International units/milliliter (IU/mL).

Log 10-transformed serum total IgE levels were expressed in Log-10 International units/milliliter (IU/mL).

Criteria for potentially clinically important (PCI) vital sign abnormalities- heart rate: greater than (>) 15 beats per minute (bpm) increase from baseline and greater than or equal to (>=) 120 bpm, >15 bpm decrease from baseline and less than or equal to (<=) 45 bpm: systolic blood pressure (SBP): >=20 millimeter of mercury (mmHg) increase from baseline and >=160 mmHg, >=20 mmHg decrease from baseline and <=90 mmHg: diastolic blood pressure (DBP): of >=15 mmHg increase from baseline and >=100 mmHg, >=15 mmHg decrease from baseline and <=50 mmHg, oral temperature <35 or >38.3 degrees centigrade: respiratory rate: <10 or >25 breaths/minute: body weight: >=7% increase or decrease from baseline.

Criteria for PCI vital sign abnormalities- heart rate: >15 bpm increase from baseline and >=120 bpm, >15 bpm decrease from baseline and <=45 bpm: SBP: >=20 mmHg increase from baseline and >=160 mmHg, >=20 mmHg decrease from baseline and <=90 mmHg: DBP: of >=15 mmHg increase from baseline and >=100 mmHg, >=15 mmHg decrease from baseline and <=50 mmHg, oral temperature <35 or >38.3 degrees centigrade: respiratory rate: <10 or >25 breaths/minute: body weight: >=7% increase or decrease from baseline.

Physical examination included examination of general appearance, skin, head, ears, eyes, nose, throat, heart, lungs, breasts, abdomen, external genitalia, extremities, neurological exam, back/spine and lymph nodes.

Physical examination included examination of general appearance, skin, head, ears, eyes, nose, throat, heart, lungs, breasts, abdomen, external genitalia, extremities, neurological exam, back/spine and lymph nodes.

Clinically significant ECG findings included - heart rate: >15 bpm increase from baseline and >=120 bpm, PR interval: >=20 millisecond (msec) change from baseline and >=220 msec: QRS interval: >=120 msec: corrected QT (QTc) interval: >450 msec for males and >470 msec for females.

Clinically significant ECG findings included - heart rate: >15 bpm increase from baseline and >=120 bpm, PR interval: >=20 msec change from baseline and >=220 msec: QRS interval: >=120 msec: QTc interval: >450 msec for males and >470 msec for females.

Following parameters were analyzed for laboratory examination: hematology (hemoglobin, hematocrit, platelet count, white blood cell count, total neutrophils, eosinophils); hepatobiliary biochemistry: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase, total bilirubin, gamma glutamyl transferase (GGT), total lactate dehydrogenase (LDH); renal function tests: blood urea nitrogen (BUN), creatinine, creatinine kinase, uric acid, albumin; electrolytes: sodium, potassium, calcium, magnesium, phosphorus; coagulation: prothrombin time and partial thromboplastin time; glucose: fasting, non-fasting; lipid profile: total cholesterol, triglycerides.

Following parameters were analyzed for laboratory examination: hematology (hemoglobin, hematocrit, platelet count, white blood cell count, total neutrophils, eosinophils); hepatobiliary biochemistry: ALT, AST, alkaline phosphatase, total bilirubin, GGT, total LDH; renal function tests: BUN, creatinine, creatinine kinase, uric acid, albumin; electrolytes: sodium, potassium, calcium, magnesium, phosphorus; coagulation: prothrombin time and partial thromboplastin time; glucose: fasting, non-fasting; lipid profile: total cholesterol, triglycerides.