Clinical trial NCT00425061: Study Evaluating the Effect of IMA-638 in Subjects With Persistent Asthma
Official title: Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 2 Study Conducted Sequentially With 3 Doses Of Ima-638 Administered Sc.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-01-22
Enrollment: 159
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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:

Primary outcomes:
measure: Change From Baseline in Morning (Ante Meridiem) Peak Expiratory Flow Rate (AM PEFR) at Day 112 - Stage 1
timeFrame: Baseline, Day 112
measure: Change From Baseline in Morning (Ante Meridiem) Peak Expiratory Flow Rate (AM PEFR) at Day 112 - Stage 2/3
timeFrame: Baseline, Day 112
Secondary outcomes:
measure: Change From Baseline in Pre-beta-agonist Forced Expiratory Volume in 1 Second (FEV1) at Day 8, 28, 56, 84 and 112 - Stage 1
timeFrame: Baseline, Day 8, 28, 56, 84, 112
measure: 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
timeFrame: Baseline, Day 8, 28, 56, 84, 112
measure: Change From Baseline in Airway Hyper-reactivity at Day 28 and 112
timeFrame: Baseline, Day 28, 112
measure: Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score at Day 8, 28, 56, 84 and 112 - Stage 1
timeFrame: Baseline, Day 8, 28, 56, 84, 112
measure: Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score at Day 8, 28, 56, 84 and 112 - Stage 2/3
timeFrame: Baseline, Day 8, 28, 56, 84, 112
measure: Percentage of Participants Who Required Treatment With Systemic Steroids for Clinical Exacerbation of Asthma - Stage 1
timeFrame: Baseline up to Day 112
measure: Percentage of Participants Who Required Treatment With Systemic Steroids for Clinical Exacerbation of Asthma - Stage 2/3
timeFrame: Baseline up to Day 112
measure: Mean Number of Puffs of Rescue Medication Used - Stage 1
timeFrame: Day 8, 28, 56, 84, 89, 91, 94, 98, 112
measure: Mean Number of Puffs of Rescue Medication Used - Stage 2/3
timeFrame: Day 8, 28, 56, 84, 89, 91, 94, 98, 112
measure: Forced Vital Capacity (FVC) - Stage 1
timeFrame: Baseline, Day 8, 28, 56, 84, 112
measure: Forced Vital Capacity (FVC) - Stage 2/3
timeFrame: Baseline, Day 8, 28, 56, 84, 112
measure: Forced Mid-Expiratory Flow Rate 25 Percent (%) to 75% (FEF25-75) - Stage 1
timeFrame: Baseline, Day 8, 28, 56, 84, 112
measure: Forced Mid-Expiratory Flow Rate 25 Percent (%) to 75% (FEF25-75) - Stage 2/3
timeFrame: Baseline, Day 8, 28, 56, 84, 112
measure: Blood Eosinophils Levels - Stage 1
timeFrame: Baseline, Day 8, 28, 56, 84, 112
measure: Blood Eosinophils Levels - Stage 2/3
timeFrame: Baseline, Day 8, 28, 56, 84, 112
measure: Log 10-transformed Serum Total Immunoglobulin E (IgE) Levels - Stage 1
timeFrame: Baseline, Day 28, 56, 84, 112
measure: Log 10-transformed Serum Total Immunoglobulin E (IgE) Levels - Stage 2/3
timeFrame: Baseline, Day 28, 56, 84, 112
measure: Serum Interleukin-13 (IL-13) Level - Stage 1
timeFrame: Baseline, Day 8, 28, 56, 84, 112
measure: Serum Interleukin-13 (IL-13) Level - Stage 2/3
timeFrame: Baseline, Day 8, 28, 56, 84, 112
Other outcomes:
measure: Number of Participants With Vital Sign Abnormalities of Potential Clinical Importance Stage 1
timeFrame: Baseline up to Day 112
measure: Number of Participants With Vital Sign Abnormalities of Potential Clinical Importance - Stage 2/3
timeFrame: Baseline up to Day 112
measure: Number of Participants With Clinically Important Changes in Physical Findings - Stage 1
timeFrame: Baseline up to Day 112
measure: Number of Participants With Clinically Important Changes in Physical Findings - Stage 2/3
timeFrame: Baseline up to Day 112
measure: Number of Participants With Electrocardiogram (ECG) Abnormalities of Potential Clinical Concern - Stage 1
timeFrame: Baseline up to Day 112
measure: Number of Participants With Electrocardiogram (ECG) Abnormalities of Potential Clinical Concern - Stage 2/3
timeFrame: Baseline up to Day 112
measure: Number of Participants With Injection Site Reaction - Stage 1
timeFrame: Baseline up to Day 112
measure: Number of Participants With Injection Site Reaction - Stage 2/3
timeFrame: Baseline up to Day 112
measure: Number of Participants With Laboratory Test Abnormalities of Potential Clinical Importance - Stage 1
timeFrame: Baseline up to Day 112
measure: Number of Participants With Laboratory Test Abnormalities of Potential Clinical Importance - Stage 2/3
timeFrame: Baseline up to Day 112
Locations:
city: Birmingham
country: United States
facility: Alabama Allergy and Asthma Center
state: Alabama
city: Montgomery
country: United States
facility: Alabama Allergy & Asthma Clinic
state: Alabama
city: Little Rock
country: United States
facility: Little Rock Allergy & Asthma
state: Arkansas
city: Crescent City
country: United States
facility: Pacific Coast Allergy
state: California
city: Fresno
country: United States
facility: ABM Research Center
state: California
city: Long Beach
country: United States
facility: Allergy and Asthma Care Center of Southern California
state: California
city: Los Angeles
country: United States
facility: Allergy Medical Clinic
state: California
city: Rancho Mirage
country: United States
facility: Advances in Medicine
state: California
city: Rolling Hills Estates
country: United States
facility: Penisula Research Associates
state: California
city: San Diego
country: United States
facility: Sharp Rees-Stealy Medical Group
state: California
city: San Diego
country: United States
facility: Allergy Associates Medical Group, Inc.
state: California
city: San Jose
country: United States
facility: Allergy & Asthma Assoc of Santa Clara Valley Research Ctr
state: California
city: San Jose
country: United States
facility: San Jose Clinical Research, Inc.
state: California
city: Stockton
country: United States
facility: Bensch Research Associates
state: California
city: Vista
country: United States
facility: Allergy and Immunology Medical Group
state: California
city: Walnut Creek
country: United States
facility: Allergy & Asthma Clinical Research, Inc.
state: California
city: Denver
country: United States
facility: National Jewish Medical & Research Center
state: Colorado
city: Denver
country: United States
facility: Colorado Allergy and Asthma Centers
state: Colorado
city: Waterbury
country: United States
facility: Waterbury Pulmonary Associates
state: Connecticut
city: Valrico
country: United States
facility: Brandon-Valico Center for Allergy & Asthma Research, LLC
state: Florida
city: West Palm Beach
country: United States
facility: Roberson Allergy & Asthma
state: Florida
city: Albany
country: United States
facility: Georgia Pollens CRC, Inc.
state: Georgia
city: Lawrenceville
country: United States
facility: DataQuest Medical Research
state: Georgia
city: Savannah
country: United States
facility: Aero Allergy Research Labs of Savannah, Inc. 505 Eisenhower
state: Georgia
city: River Forest
country: United States
facility: Allergy and Asthma Center of Chicago
state: Illinois
city: Fort Wayne
country: United States
facility: Fort Wayne Medical Institute
state: Indiana
city: South Bend
country: United States
facility: South Bend Clinic
state: Indiana
city: Overland Park
country: United States
facility: College Park Family Care Center
state: Kansas
city: Overland Park
country: United States
facility: Kansas City Allergy & Asthma
state: Kansas
city: Crescent Springs
country: United States
facility: Abraham Research, PLLC
state: Kentucky
city: Metairie
country: United States
facility: Clinical Research Specialists
state: Louisiana
city: Gardner
country: United States
facility: Allergy and Arthritis Family
state: Massachusetts
city: Taunton
country: United States
facility: Center for Clinical Research
state: Massachusetts
city: Minneapolis
country: United States
facility: Clinical Research Institute
state: Minnesota
city: Jackson
country: United States
facility: Mississippi Asthma and Allergy Clinic, P.A.
state: Mississippi
city: St Louis
country: United States
facility: The Clinical Research Center LLC
state: Missouri
city: St. Louis
country: United States
facility: Midwest Clinical Research LLC
state: Missouri
city: Missoula
country: United States
facility: Montana Medical Research, Inc
state: Montana
city: Omaha
country: United States
facility: Midwest Allergy and Asthma Clinic
state: Nebraska
city: Las Vegas
country: United States
facility: Allergy and Asthma Assoc
state: Nevada
city: Skillman
country: United States
facility: Princeton Center for Clinical Research
state: New Jersey
city: Summit
country: United States
facility: Pulmonary and Allergy Associates
state: New Jersey
city: Albany
country: United States
facility: Pulmonary & Critical Care Services, P.C.5 Palisades Dr., Su
state: New York
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Rochester
country: United States
facility: AAIR Research Center
state: New York
city: Asheville
country: United States
facility: Regional Allergy and Asthma Consultants, P.A.
state: North Carolina
city: Mount Pleasant
country: United States
facility: AAC Research, PC
state: North Carolina
city: Raleigh
country: United States
facility: North Carolina Clinical Research
state: North Carolina
city: Canton
country: United States
facility: Allergy & Respiratory Center
state: Ohio
city: Cincinnati
country: United States
facility: New Horizons Clinical Research
state: Ohio
city: Sylvania
country: United States
facility: Toledo Center for Clinial Researcch
state: Ohio
city: Oklahoma City
country: United States
facility: Allergy, Asthma & Clinical Research Center
state: Oklahoma
city: Eugene
country: United States
facility: Allergy and Asthma Research Group
state: Oregon
city: Lake Oswego
country: United States
facility: Allergy, Asthma and Dermatology Research Center, LLC 3975 Me
state: Oregon
city: Medford
country: United States
facility: Clinical Research Institute of Southern Oregon
state: Oregon
city: Portland
country: United States
facility: Allergy Associates Research Center
state: Oregon
city: Bethlehem
country: United States
facility: Valley Clinical Research Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Allergy & Asthma Research of New Jersey
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allergy and Clinical Immunology
state: Pennsylvania
city: Sellersville
country: United States
facility: Pulmonary and Allergy Associates
state: Pennsylvania
city: Lincoln
country: United States
facility: AAPRI Clinical Research Institute
state: Rhode Island
city: Greenville
country: United States
facility: Allergic Disease and Asthma Center Research, PA
state: South Carolina
city: Mount Pleasant
country: United States
facility: AAC Research, PC
state: South Carolina
city: Knoxville
country: United States
facility: East Tennessee Center for Clinical Research
state: Tennessee
city: Austin
country: United States
facility: Lovelace Scientific Resources
state: Texas
city: El Paso
country: United States
facility: Allergy and Asthma Research Center of El Paso
state: Texas
city: Friendswood
country: United States
facility: Family Center for Asthma & Allergic Diseases
state: Texas
city: Houston
country: United States
facility: Allergy and Asthma Associates
state: Texas
city: Houston
country: United States
facility: Clinical Trials North Houston
state: Texas
city: Houston
country: United States
facility: Clinical Trial Network
state: Texas
city: Killeen
country: United States
facility: The Allergy and Asthma Clinic of Central Texas
state: Texas
city: San Antonio
country: United States
facility: Allergy Asthma and Immunology
state: Texas
city: South Burlington
country: United States
facility: Timber Lane Allergy and Asthma Research LLC
state: Vermont
city: Richmond
country: United States
facility: Virginia Adult & Pediatric Allergy & Asthma, P.C.
state: Virginia
city: Madison
country: United States
facility: University of Wisconsin Medical School
state: Wisconsin
city: Milwaukee
country: United States
facility: Auroroa Health Care, Inc.
state: Wisconsin
city: Mississauga
country: Canada
facility: Alpha Medical Research Inc.
state: Ontario
city: Niagara Falls
country: Canada
facility: Alexander Medical Innovations Inc.
state: Ontario
city: Ottawa
country: Canada
facility: Allergy and Asthma Research Centre
state: Ontario
city: Longueuil
country: Canada
facility: Recherche Invascor Inc
state: Quebec
city: Montreal
country: Canada
facility: Hopital du Sacre-Coeur de Montreal
state: Quebec
city: Trois-Rivieres
country: Canada
facility: CIC Mauricie Inc.
state: Quebec
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: