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

Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 2 Study Conducted Sequentially With 3 Doses Of Ima-638 Administered Sc.

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

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Other: placebo; Biological: IMA-638

• Study Type: Interventional
• Enrollment (Actual): 159
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Mississauga, Ontario, Canada, L5A 3V4
      • Alpha Medical Research Inc.
    • Niagara Falls, Ontario, Canada, L2G 1J4
      • Alexander Medical Innovations Inc.
    • Ottawa, Ontario, Canada, K1Y 4G2
      • Allergy and Asthma Research Centre
  • Quebec
    • Longueuil, Quebec, Canada, J4N 1E1
      • Recherche Invascor Inc
    • Montreal, Quebec, Canada, H4J 1C5
      • Hopital Du Sacre-Coeur de Montreal
    • Trois-Rivieres, Quebec, Canada, G8T 7A1
      • CIC Mauricie inc.
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35209
      • Alabama Allergy and Asthma Center
    • Montgomery, Alabama, United States, 36106
      • Alabama Allergy & Asthma Clinic
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Little Rock Allergy & Asthma
  • California
    • Crescent City, California, United States, 95531
      • Pacific Coast Allergy
    • Fresno, California, United States, 93720
      • ABM Research Center
    • Long Beach, California, United States, 90808
      • Allergy and Asthma Care Center of Southern California
    • Los Angeles, California, United States, 90025
      • Allergy Medical Clinic
    • Rancho Mirage, California, United States, 92270
      • Advances in Medicine
    • Rolling Hills Estates, California, United States, 90274
      • Penisula Research Associates
    • San Diego, California, United States, 92101
      • Sharp Rees-Stealy Medical Group
    • San Diego, California, United States, 92120
      • Allergy Associates Medical Group, Inc.
    • San Jose, California, United States, 95128
      • San Jose Clinical Research, Inc.
    • San Jose, California, United States, 95117
      • Allergy & Asthma Assoc of Santa Clara Valley Research Ctr
    • Stockton, California, United States, 95207
      • Bensch Research Associates
    • Vista, California, United States, 92083
      • Allergy and Immunology Medical Group
    • Walnut Creek, California, United States, 94598
      • Allergy & Asthma Clinical Research, Inc.
  • Colorado
    • Denver, Colorado, United States, 80230
      • Colorado Allergy and Asthma Centers
    • Denver, Colorado, United States, 80206
      • National Jewish Medical & Research Center
  • Connecticut
    • Waterbury, Connecticut, United States, 06708
      • Waterbury Pulmonary Associates
  • Florida
    • Valrico, Florida, United States, 33594
      • Brandon-Valico Center for Allergy & Asthma Research, LLC
    • West Palm Beach, Florida, United States, 33401
      • Roberson Allergy & Asthma
  • Georgia
    • Albany, Georgia, United States, 31707
      • Georgia Pollens CRC, Inc.
    • Lawrenceville, Georgia, United States, 30045
      • DataQuest Medical Research
    • Savannah, Georgia, United States, 31406
      • Aero Allergy Research Labs of Savannah, Inc. 505 Eisenhower
  • Illinois
    • River Forest, Illinois, United States, 60305
      • Allergy and Asthma Center of Chicago
  • Indiana
    • Fort Wayne, Indiana, United States, 46815
      • Fort Wayne Medical Institute
    • South Bend, Indiana, United States, 46617
      • South Bend Clinic
  • Kansas
    • Overland Park, Kansas, United States, 66210
      • Kansas City Allergy & Asthma
    • Overland Park, Kansas, United States, 66210
      • College Park Family Care Center
  • Kentucky
    • Crescent Springs, Kentucky, United States, 41017
      • Abraham Research, PLLC
  • Louisiana
    • Metairie, Louisiana, United States, 70006
      • Clinical Research Specialists
  • Massachusetts
    • Gardner, Massachusetts, United States, 01440
      • Allergy and Arthritis Family
    • Taunton, Massachusetts, United States, 02780
      • Center for Clinical Research
  • Minnesota
    • Minneapolis, Minnesota, United States, 55402
      • Clinical Research Institute
  • Mississippi
    • Jackson, Mississippi, United States, 39202
      • Mississippi Asthma and Allergy Clinic, P.A.
  • Missouri
    • St Louis, Missouri, United States, 63141
      • The Clinical Research Center LLC
    • St. Louis, Missouri, United States, 63141
      • Midwest Clinical Research LLC
  • Montana
    • Missoula, Montana, United States, 59808
      • Montana Medical Research, Inc
  • Nebraska
    • Omaha, Nebraska, United States, 68130
      • Midwest Allergy and Asthma Clinic
  • Nevada
    • Las Vegas, Nevada, United States, 89102
      • Allergy and Asthma Assoc
  • New Jersey
    • Skillman, New Jersey, United States, 08558
      • Princeton Center For Clinical Research
    • Summit, New Jersey, United States, 07901
      • Pulmonary and Allergy Associates
  • New York
    • Albany, New York, United States, 12205
      • Pulmonary & Critical Care Services, P.C.5 Palisades Dr., Su
    • Bronx, New York, United States, 10461
      • Montefiore Medical Center
    • Rochester, New York, United States, 14618
      • AAIR Research Center
  • North Carolina
    • Asheville, North Carolina, United States, 28801
      • Regional Allergy and Asthma Consultants, P.A.
    • Mount Pleasant, North Carolina, United States, 29464
      • AAC Research, PC
    • Raleigh, North Carolina, United States, 27607
      • North Carolina Clinical Research
  • Ohio
    • Canton, Ohio, United States, 44718
      • Allergy & Respiratory Center
    • Cincinnati, Ohio, United States, 45242
      • New Horizons Clinical Research
    • Sylvania, Ohio, United States, 43560
      • Toledo Center for Clinial Researcch
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73120
      • Allergy, Asthma & Clinical Research Center
  • Oregon
    • Eugene, Oregon, United States, 97401
      • Allergy and Asthma Research Group
    • Lake Oswego, Oregon, United States, 97035
      • Allergy, Asthma and Dermatology Research Center, LLC 3975 Me
    • Medford, Oregon, United States, 97504
      • Clinical Research Institute of Southern Oregon
    • Portland, Oregon, United States, 97213
      • Allergy Associates Research Center
  • Pennsylvania
    • Bethlehem, Pennsylvania, United States, 18020
      • Valley Clinical Research Center
    • Philadelphia, Pennsylvania, United States, 19115
      • Allergy & Asthma Research of New Jersey
    • Pittsburgh, Pennsylvania, United States, 15241
      • Allergy and Clinical Immunology
    • Sellersville, Pennsylvania, United States, 18960
      • Pulmonary and Allergy Associates
  • Rhode Island
    • Lincoln, Rhode Island, United States, 02865
      • AAPRI Clinical Research Institute
  • South Carolina
    • Greenville, South Carolina, United States, 29607
      • Allergic Disease and Asthma Center Research, PA
    • Mount Pleasant, South Carolina, United States, 29464
      • AAC Research, PC
  • Tennessee
    • Knoxville, Tennessee, United States, 37909
      • East Tennessee Center for Clinical Research
  • Texas
    • Austin, Texas, United States, 78759
      • Lovelace Scientific Resources
    • El Paso, Texas, United States, 79925
      • Allergy and Asthma Research Center of El Paso
    • Friendswood, Texas, United States, 77546
      • Family Center for Asthma & Allergic Diseases
    • Houston, Texas, United States, 77074
      • Clinical Trial Network
    • Houston, Texas, United States, 77054
      • Allergy and Asthma Associates
    • Houston, Texas, United States, 77070
      • Clinical Trials North Houston
    • Killeen, Texas, United States, 76542
      • The Allergy and Asthma Clinic of Central Texas
    • San Antonio, Texas, United States, 78229
      • Allergy Asthma and Immunology
  • Vermont
    • South Burlington, Vermont, United States, 05403
      • Timber Lane Allergy and Asthma Research LLC
  • Virginia
    • Richmond, Virginia, United States, 23229
      • Virginia Adult & Pediatric Allergy & Asthma, P.C.
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin Medical School
    • Milwaukee, Wisconsin, United States, 53209
      • Auroroa Health Care, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Biological: IMA-638; SC Injection, 12 weeks
Experimental: 2	Biological: IMA-638; SC Injection, 12 weeks
Placebo Comparator: 3	Other: placebo; placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Baseline, Day 112

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Baseline, Day 8, 28, 56, 84, 112
Change From Baseline in Airway Hyper-reactivity at Day 28 and 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.	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.	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.	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
Percentage of Participants Who Required Treatment With Systemic Steroids for Clinical Exacerbation of Asthma - Stage 2/3		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.	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.	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.	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.	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.	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.	Baseline, Day 8, 28, 56, 84, 112
Blood Eosinophils Levels - Stage 1		Baseline, Day 8, 28, 56, 84, 112
Blood Eosinophils Levels - Stage 2/3		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).	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).	Baseline, Day 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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Vital Sign Abnormalities of Potential Clinical Importance Stage 1	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.	Baseline up to Day 112
Number of Participants With Vital Sign Abnormalities of Potential Clinical Importance - Stage 2/3	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.	Baseline up to Day 112
Number of Participants With Clinically Important Changes in Physical Findings - Stage 1	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.	Baseline up to Day 112
Number of Participants With Clinically Important Changes in Physical Findings - Stage 2/3	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.	Baseline up to Day 112
Number of Participants With Electrocardiogram (ECG) Abnormalities of Potential Clinical Concern - Stage 1	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.	Baseline up to Day 112
Number of Participants With Electrocardiogram (ECG) Abnormalities of Potential Clinical Concern - Stage 2/3	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.	Baseline up to Day 112
Number of Participants With Injection Site Reaction - Stage 1		Baseline up to Day 112
Number of Participants With Injection Site Reaction - Stage 2/3		Baseline up to Day 112
Number of Participants With Laboratory Test Abnormalities of Potential Clinical Importance - Stage 1	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.	Baseline up to Day 112
Number of Participants With Laboratory Test Abnormalities of Potential Clinical Importance - Stage 2/3	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.	Baseline up to Day 112

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: February 1, 2007
• Primary Completion (Actual): August 1, 2008
• Study Completion (Actual): August 1, 2008

Study Registration Dates

• First Submitted: January 18, 2007
• First Submitted That Met QC Criteria: January 19, 2007
• First Posted (Estimate): January 22, 2007

Study Record Updates

• Last Update Posted (Estimate): January 14, 2015
• Last Update Submitted That Met QC Criteria: January 12, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: 3174K1-201; B2421007 (Other Identifier: Alias Study Number)