Primary purpose is to assess if IMA-638 is safe and improves asthma in subjects with persistent asthma.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
159
Change From Baseline in Morning (Ante Meridiem) Peak Expiratory Flow Rate (AM PEFR) at Day 112 - Stage 1
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.
Time frame: Baseline, Day 112
Change From Baseline in Morning (Ante Meridiem) Peak Expiratory Flow Rate (AM PEFR) at Day 112 - Stage 2/3
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.
Time frame: Baseline, Day 112
Change From Baseline in Pre-beta-agonist Forced Expiratory Volume in 1 Second (FEV1) at Day 8, 28, 56, 84 and 112 - Stage 1
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.
Time frame: Baseline, Day 8, 28, 56, 84, 112
Change From Baseline in Pre-beta-agonist Forced Expiratory Volume in 1 Second (FEV1) at Day 8, 28, 56, 84 and 112 - Stage 2/3
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.
Time frame: Baseline, Day 8, 28, 56, 84, 112
Change From Baseline in Airway Hyper-reactivity at Day 28 and 112
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Alabama Allergy and Asthma Center
Birmingham, Alabama, United States
Alabama Allergy & Asthma Clinic
Montgomery, Alabama, United States
Little Rock Allergy & Asthma
Little Rock, Arkansas, United States
Pacific Coast Allergy
Crescent City, California, United States
ABM Research Center
Fresno, California, United States
Allergy and Asthma Care Center of Southern California
Long Beach, California, United States
Allergy Medical Clinic
Los Angeles, California, United States
Advances in Medicine
Rancho Mirage, California, United States
Penisula Research Associates
Rolling Hills Estates, California, United States
Sharp Rees-Stealy Medical Group
San Diego, California, United States
...and 72 more locations
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.
Time frame: Baseline, Day 28, 112
Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score at Day 8, 28, 56, 84 and 112 - Stage 1
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.
Time frame: Baseline, Day 8, 28, 56, 84, 112
Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score at Day 8, 28, 56, 84 and 112 - Stage 2/3
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.
Time frame: Baseline, Day 8, 28, 56, 84, 112
Percentage of Participants Who Required Treatment With Systemic Steroids for Clinical Exacerbation of Asthma - Stage 1
Time frame: Baseline up to Day 112
Percentage of Participants Who Required Treatment With Systemic Steroids for Clinical Exacerbation of Asthma - Stage 2/3
Time frame: Baseline up to Day 112
Mean Number of Puffs of Rescue Medication Used - Stage 1
The rescue medication taken for needed symptoms was a short acting beta agonist (SABA) inhaler. Albuterol, 90 microgram (mcg)/puff, was recommended for use.
Time frame: Day 8, 28, 56, 84, 89, 91, 94, 98, 112
Mean Number of Puffs of Rescue Medication Used - Stage 2/3
The rescue medication taken for needed symptoms was a SABA inhaler. Albuterol, 90 mcg/puff, was recommended for use.
Time frame: Day 8, 28, 56, 84, 89, 91, 94, 98, 112
Forced Vital Capacity (FVC) - Stage 1
FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.
Time frame: Baseline, Day 8, 28, 56, 84, 112
Forced Vital Capacity (FVC) - Stage 2/3
FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.
Time frame: Baseline, Day 8, 28, 56, 84, 112
Forced Mid-Expiratory Flow Rate 25 Percent (%) to 75% (FEF25-75) - Stage 1
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.
Time frame: Baseline, Day 8, 28, 56, 84, 112
Forced Mid-Expiratory Flow Rate 25 Percent (%) to 75% (FEF25-75) - Stage 2/3
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.
Time frame: Baseline, Day 8, 28, 56, 84, 112
Blood Eosinophils Levels - Stage 1
Time frame: Baseline, Day 8, 28, 56, 84, 112
Blood Eosinophils Levels - Stage 2/3
Time frame: Baseline, Day 8, 28, 56, 84, 112
Log 10-transformed Serum Total Immunoglobulin E (IgE) Levels - Stage 1
Log 10-transformed serum total IgE levels were expressed in Log-10 International units/milliliter (IU/mL).
Time frame: Baseline, Day 28, 56, 84, 112
Log 10-transformed Serum Total Immunoglobulin E (IgE) Levels - Stage 2/3
Log 10-transformed serum total IgE levels were expressed in Log-10 International units/milliliter (IU/mL).
Time frame: Baseline, Day 28, 56, 84, 112
Serum Interleukin-13 (IL-13) Level - Stage 1
Time frame: Baseline, Day 8, 28, 56, 84, 112
Serum Interleukin-13 (IL-13) Level - Stage 2/3
Time frame: Baseline, Day 8, 28, 56, 84, 112