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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00425061
First received: January 18, 2007
Last updated: January 12, 2015
Last verified: January 2015
  Purpose

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


Condition Intervention Phase
Asthma
Biological: IMA-638
Other: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 2 Study Conducted Sequentially With 3 Doses Of Ima-638 Administered Sc.

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Change From Baseline in Morning (Ante Meridiem) Peak Expiratory Flow Rate (AM PEFR) at Day 112 - Stage 1 [ Time Frame: Baseline, Day 112 ] [ Designated as safety issue: No ]
    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 2/3 [ Time Frame: Baseline, Day 112 ] [ Designated as safety issue: No ]
    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:
  • Change From Baseline in Pre-beta-agonist Forced Expiratory Volume in 1 Second (FEV1) at Day 8, 28, 56, 84 and 112 - Stage 1 [ Time Frame: Baseline, Day 8, 28, 56, 84, 112 ] [ Designated as safety issue: No ]
    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 Pre-beta-agonist Forced Expiratory Volume in 1 Second (FEV1) at Day 8, 28, 56, 84 and 112 - Stage 2/3 [ Time Frame: Baseline, Day 8, 28, 56, 84, 112 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, Day 28, 112 ] [ Designated as safety issue: No ]
    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 1 [ Time Frame: Baseline, Day 8, 28, 56, 84, 112 ] [ Designated as safety issue: No ]
    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 Asthma Control Questionnaire-5 (ACQ-5) Score at Day 8, 28, 56, 84 and 112 - Stage 2/3 [ Time Frame: Baseline, Day 8, 28, 56, 84, 112 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants Who Required Treatment With Systemic Steroids for Clinical Exacerbation of Asthma - Stage 1 [ Time Frame: Baseline up to Day 112 ] [ Designated as safety issue: No ]
  • Percentage of Participants Who Required Treatment With Systemic Steroids for Clinical Exacerbation of Asthma - Stage 2/3 [ Time Frame: Baseline up to Day 112 ] [ Designated as safety issue: No ]
  • Mean Number of Puffs of Rescue Medication Used - Stage 1 [ Time Frame: Day 8, 28, 56, 84, 89, 91, 94, 98, 112 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 8, 28, 56, 84, 89, 91, 94, 98, 112 ] [ Designated as safety issue: No ]
    The rescue medication taken for needed symptoms was a SABA inhaler. Albuterol, 90 mcg/puff, was recommended for use.

  • Forced Vital Capacity (FVC) - Stage 1 [ Time Frame: Baseline, Day 8, 28, 56, 84, 112 ] [ Designated as safety issue: No ]
    FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.

  • Forced Vital Capacity (FVC) - Stage 2/3 [ Time Frame: Baseline, Day 8, 28, 56, 84, 112 ] [ Designated as safety issue: No ]
    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 1 [ Time Frame: Baseline, Day 8, 28, 56, 84, 112 ] [ Designated as safety issue: No ]
    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.

  • Forced Mid-Expiratory Flow Rate 25 Percent (%) to 75% (FEF25-75) - Stage 2/3 [ Time Frame: Baseline, Day 8, 28, 56, 84, 112 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, Day 8, 28, 56, 84, 112 ] [ Designated as safety issue: No ]
  • Blood Eosinophils Levels - Stage 2/3 [ Time Frame: Baseline, Day 8, 28, 56, 84, 112 ] [ Designated as safety issue: No ]
  • Log 10-transformed Serum Total Immunoglobulin E (IgE) Levels - Stage 1 [ Time Frame: Baseline, Day 28, 56, 84, 112 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, Day 28, 56, 84, 112 ] [ Designated as safety issue: No ]
    Log 10-transformed serum total IgE levels were expressed in Log-10 International units/milliliter (IU/mL).

  • Serum Interleukin-13 (IL-13) Level - Stage 1 [ Time Frame: Baseline, Day 8, 28, 56, 84, 112 ] [ Designated as safety issue: No ]
  • Serum Interleukin-13 (IL-13) Level - Stage 2/3 [ Time Frame: Baseline, Day 8, 28, 56, 84, 112 ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Number of Participants With Vital Sign Abnormalities of Potential Clinical Importance Stage 1 [ Time Frame: Baseline up to Day 112 ] [ Designated as safety issue: Yes ]
    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.

  • Number of Participants With Vital Sign Abnormalities of Potential Clinical Importance - Stage 2/3 [ Time Frame: Baseline up to Day 112 ] [ Designated as safety issue: Yes ]
    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.

  • Number of Participants With Clinically Important Changes in Physical Findings - Stage 1 [ Time Frame: Baseline up to Day 112 ] [ Designated as safety issue: Yes ]
    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.

  • Number of Participants With Clinically Important Changes in Physical Findings - Stage 2/3 [ Time Frame: Baseline up to Day 112 ] [ Designated as safety issue: Yes ]
    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.

  • Number of Participants With Electrocardiogram (ECG) Abnormalities of Potential Clinical Concern - Stage 1 [ Time Frame: Baseline up to Day 112 ] [ Designated as safety issue: Yes ]
    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.

  • Number of Participants With Electrocardiogram (ECG) Abnormalities of Potential Clinical Concern - Stage 2/3 [ Time Frame: Baseline up to Day 112 ] [ Designated as safety issue: Yes ]
    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.

  • Number of Participants With Injection Site Reaction - Stage 1 [ Time Frame: Baseline up to Day 112 ] [ Designated as safety issue: Yes ]
  • Number of Participants With Injection Site Reaction - Stage 2/3 [ Time Frame: Baseline up to Day 112 ] [ Designated as safety issue: Yes ]
  • Number of Participants With Laboratory Test Abnormalities of Potential Clinical Importance - Stage 1 [ Time Frame: Baseline up to Day 112 ] [ Designated as safety issue: Yes ]
    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.

  • Number of Participants With Laboratory Test Abnormalities of Potential Clinical Importance - Stage 2/3 [ Time Frame: Baseline up to Day 112 ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 159
Study Start Date: February 2007
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Biological: IMA-638
SC Injection, 12 weeks
Experimental: 2 Biological: IMA-638
SC Injection, 12 weeks
Placebo Comparator: 3 Other: placebo
placebo

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00425061

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

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00425061     History of Changes
Other Study ID Numbers: 3174K1-201, B2421007
Study First Received: January 18, 2007
Results First Received: November 6, 2014
Last Updated: January 12, 2015
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on July 28, 2015