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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00425061
• Other study ID #: 3174K1-201
• Secondary ID: B2421007
• Status: Completed
• Phase: Phase 2
• First received: January 18, 2007
• Last updated: January 12, 2015
• Start date: February 2007
• Est. completion date: August 2008

Study information

• Verified date: January 2015
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 159
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Biological:
• IMA-638
SC Injection, 12 weeks
• IMA-638
SC Injection, 12 weeks

Other:
• placebo
placebo

Locations

Country	Name	City	State
Canada	Recherche Invascor Inc	Longueuil	Quebec
Canada	Alpha Medical Research Inc.	Mississauga	Ontario
Canada	Hopital du Sacre-Coeur de Montreal	Montreal	Quebec
Canada	Alexander Medical Innovations Inc.	Niagara Falls	Ontario
Canada	Allergy and Asthma Research Centre	Ottawa	Ontario
Canada	CIC Mauricie Inc.	Trois-Rivieres	Quebec
United States	Georgia Pollens CRC, Inc.	Albany	Georgia
United States	Pulmonary & Critical Care Services, P.C.5 Palisades Dr., Su	Albany	New York
United States	Regional Allergy and Asthma Consultants, P.A.	Asheville	North Carolina
United States	Lovelace Scientific Resources	Austin	Texas
United States	Valley Clinical Research Center	Bethlehem	Pennsylvania
United States	Alabama Allergy and Asthma Center	Birmingham	Alabama
United States	Montefiore Medical Center	Bronx	New York
United States	Allergy & Respiratory Center	Canton	Ohio
United States	New Horizons Clinical Research	Cincinnati	Ohio
United States	Pacific Coast Allergy	Crescent City	California
United States	Abraham Research, PLLC	Crescent Springs	Kentucky
United States	Colorado Allergy and Asthma Centers	Denver	Colorado
United States	National Jewish Medical & Research Center	Denver	Colorado
United States	Allergy and Asthma Research Center of El Paso	El Paso	Texas
United States	Allergy and Asthma Research Group	Eugene	Oregon
United States	Fort Wayne Medical Institute	Fort Wayne	Indiana
United States	ABM Research Center	Fresno	California
United States	Family Center for Asthma & Allergic Diseases	Friendswood	Texas
United States	Allergy and Arthritis Family	Gardner	Massachusetts
United States	Allergic Disease and Asthma Center Research, PA	Greenville	South Carolina
United States	Allergy and Asthma Associates	Houston	Texas
United States	Clinical Trial Network	Houston	Texas
United States	Clinical Trials North Houston	Houston	Texas
United States	Mississippi Asthma and Allergy Clinic, P.A.	Jackson	Mississippi
United States	The Allergy and Asthma Clinic of Central Texas	Killeen	Texas
United States	East Tennessee Center for Clinical Research	Knoxville	Tennessee
United States	Allergy, Asthma and Dermatology Research Center, LLC 3975 Me	Lake Oswego	Oregon
United States	Allergy and Asthma Assoc	Las Vegas	Nevada
United States	DataQuest Medical Research	Lawrenceville	Georgia
United States	AAPRI Clinical Research Institute	Lincoln	Rhode Island
United States	Little Rock Allergy & Asthma	Little Rock	Arkansas
United States	Allergy and Asthma Care Center of Southern California	Long Beach	California
United States	Allergy Medical Clinic	Los Angeles	California
United States	University of Wisconsin Medical School	Madison	Wisconsin
United States	Clinical Research Institute of Southern Oregon	Medford	Oregon
United States	Clinical Research Specialists	Metairie	Louisiana
United States	Auroroa Health Care, Inc.	Milwaukee	Wisconsin
United States	Clinical Research Institute	Minneapolis	Minnesota
United States	Montana Medical Research, Inc	Missoula	Montana
United States	Alabama Allergy & Asthma Clinic	Montgomery	Alabama
United States	AAC Research, PC	Mount Pleasant	South Carolina
United States	AAC Research, PC	Mount Pleasant	North Carolina
United States	Allergy, Asthma & Clinical Research Center	Oklahoma City	Oklahoma
United States	Midwest Allergy and Asthma Clinic	Omaha	Nebraska
United States	College Park Family Care Center	Overland Park	Kansas
United States	Kansas City Allergy & Asthma	Overland Park	Kansas
United States	Allergy & Asthma Research of New Jersey	Philadelphia	Pennsylvania
United States	Allergy and Clinical Immunology	Pittsburgh	Pennsylvania
United States	Allergy Associates Research Center	Portland	Oregon
United States	North Carolina Clinical Research	Raleigh	North Carolina
United States	Advances in Medicine	Rancho Mirage	California
United States	Virginia Adult & Pediatric Allergy & Asthma, P.C.	Richmond	Virginia
United States	Allergy and Asthma Center of Chicago	River Forest	Illinois
United States	AAIR Research Center	Rochester	New York
United States	Penisula Research Associates	Rolling Hills Estates	California
United States	Allergy Asthma and Immunology	San Antonio	Texas
United States	Allergy Associates Medical Group, Inc.	San Diego	California
United States	Sharp Rees-Stealy Medical Group	San Diego	California
United States	Allergy & Asthma Assoc of Santa Clara Valley Research Ctr	San Jose	California
United States	San Jose Clinical Research, Inc.	San Jose	California
United States	Aero Allergy Research Labs of Savannah, Inc. 505 Eisenhower	Savannah	Georgia
United States	Pulmonary and Allergy Associates	Sellersville	Pennsylvania
United States	Princeton Center for Clinical Research	Skillman	New Jersey
United States	South Bend Clinic	South Bend	Indiana
United States	Timber Lane Allergy and Asthma Research LLC	South Burlington	Vermont
United States	The Clinical Research Center LLC	St Louis	Missouri
United States	Midwest Clinical Research LLC	St. Louis	Missouri
United States	Bensch Research Associates	Stockton	California
United States	Pulmonary and Allergy Associates	Summit	New Jersey
United States	Toledo Center for Clinial Researcch	Sylvania	Ohio
United States	Center for Clinical Research	Taunton	Massachusetts
United States	Brandon-Valico Center for Allergy & Asthma Research, LLC	Valrico	Florida
United States	Allergy and Immunology Medical Group	Vista	California
United States	Allergy & Asthma Clinical Research, Inc.	Walnut Creek	California
United States	Waterbury Pulmonary Associates	Waterbury	Connecticut
United States	Roberson Allergy & Asthma	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	Yes
Other	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	Yes
Other	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	Yes
Other	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	Yes
Other	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	Yes
Other	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	Yes
Other	Number of Participants With Injection Site Reaction - Stage 1		Baseline up to Day 112	Yes
Other	Number of Participants With Injection Site Reaction - Stage 2/3		Baseline up to Day 112	Yes
Other	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	Yes
Other	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	Yes
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Percentage of Participants Who Required Treatment With Systemic Steroids for Clinical Exacerbation of Asthma - Stage 1		Baseline up to Day 112	No
Secondary	Percentage of Participants Who Required Treatment With Systemic Steroids for Clinical Exacerbation of Asthma - Stage 2/3		Baseline up to Day 112	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Blood Eosinophils Levels - Stage 1		Baseline, Day 8, 28, 56, 84, 112	No
Secondary	Blood Eosinophils Levels - Stage 2/3		Baseline, Day 8, 28, 56, 84, 112	No
Secondary	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	No
Secondary	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	No
Secondary	Serum Interleukin-13 (IL-13) Level - Stage 1		Baseline, Day 8, 28, 56, 84, 112	No
Secondary	Serum Interleukin-13 (IL-13) Level - Stage 2/3		Baseline, Day 8, 28, 56, 84, 112	No

External Links

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