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

Phase 2

Completed

Conditions: Asthma

Registration Number: NCT00425061

Lead Sponsor: Pfizer

Brief Summary: Primary purpose is to assess if IMA-638 is safe and improves asthma in subjects with persistent asthma.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 159

Inclusion Criteria

Generally healthy men and women with persistent asthma, 18 to 70 years of age, with body weight between 50 kg and 115 kg.
History of treatment with a medium to high dose of inhaled corticosteroids (ICS), with or without long-acting beta-agonists (LABA), for at least 2 months prior to the screening visit and must remain constant during the study.
FEV1 ≥ 55% to ≤ 80% predicted and demonstrated improvement in FEV1 (L) with inhaled albuterol (salbutamol) (reversibility) of ≥ 12%.

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Morning (Ante Meridiem) Peak Expiratory Flow Rate (AM PEFR) at Day 112 - Stage 2/3	Baseline, Day 112	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.
Change From Baseline in Morning (Ante Meridiem) Peak Expiratory Flow Rate (AM PEFR) at Day 112 - Stage 1	Baseline, Day 112	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.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score at Day 8, 28, 56, 84 and 112 - Stage 1	Baseline, Day 8, 28, 56, 84, 112	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.
Change From Baseline in Pre-beta-agonist Forced Expiratory Volume in 1 Second (FEV1) at Day 8, 28, 56, 84 and 112 - Stage 1	Baseline, Day 8, 28, 56, 84, 112	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.
Change From Baseline in Airway Hyper-reactivity at Day 28 and 112	Baseline, Day 28, 112	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.
Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score at Day 8, 28, 56, 84 and 112 - Stage 2/3	Baseline, Day 8, 28, 56, 84, 112	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.
Forced Vital Capacity (FVC) - Stage 1	Baseline, Day 8, 28, 56, 84, 112	FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.
Forced Mid-Expiratory Flow Rate 25 Percent (%) to 75% (FEF25-75) - Stage 2/3	Baseline, Day 8, 28, 56, 84, 112	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.
Blood Eosinophils Levels - Stage 1	Baseline, Day 8, 28, 56, 84, 112
Serum Interleukin-13 (IL-13) Level - Stage 1	Baseline, Day 8, 28, 56, 84, 112
Serum Interleukin-13 (IL-13) Level - Stage 2/3	Baseline, Day 8, 28, 56, 84, 112
Forced Vital Capacity (FVC) - Stage 2/3	Baseline, Day 8, 28, 56, 84, 112	FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.
Blood Eosinophils Levels - Stage 2/3	Baseline, Day 8, 28, 56, 84, 112
Percentage of Participants Who Required Treatment With Systemic Steroids for Clinical Exacerbation of Asthma - Stage 1	Baseline up to Day 112
Mean Number of Puffs of Rescue Medication Used - Stage 1	Day 8, 28, 56, 84, 89, 91, 94, 98, 112	The rescue medication taken for needed symptoms was a short acting beta agonist (SABA) inhaler. Albuterol, 90 microgram (mcg)/puff, was recommended for use.
Mean Number of Puffs of Rescue Medication Used - Stage 2/3	Day 8, 28, 56, 84, 89, 91, 94, 98, 112	The rescue medication taken for needed symptoms was a SABA inhaler. Albuterol, 90 mcg/puff, was recommended for use.
Percentage of Participants Who Required Treatment With Systemic Steroids for Clinical Exacerbation of Asthma - Stage 2/3	Baseline up to Day 112
Log 10-transformed Serum Total Immunoglobulin E (IgE) Levels - Stage 1	Baseline, Day 28, 56, 84, 112	Log 10-transformed serum total IgE levels were expressed in Log-10 International units/milliliter (IU/mL).
Log 10-transformed Serum Total Immunoglobulin E (IgE) Levels - Stage 2/3	Baseline, Day 28, 56, 84, 112	Log 10-transformed serum total IgE levels were expressed in Log-10 International units/milliliter (IU/mL).
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	Baseline, Day 8, 28, 56, 84, 112	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.
Forced Mid-Expiratory Flow Rate 25 Percent (%) to 75% (FEF25-75) - Stage 1	Baseline, Day 8, 28, 56, 84, 112	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.

Trial Locations

Locations (80): 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
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Alabama Allergy and Asthma Center
🇺🇸Birmingham, Alabama, United States