AsthmaPhase 2NCT00425061

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

A Phase 2 study testing IMA-638 in people with Asthma, run by Pfizer at 82 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Primary purpose is to assess if IMA-638 is safe and improves asthma in subjects with persistent asthma. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Asthma
What is being tested?: IMA-638
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 159 participants
Where: 82 sitesin 2 countries
Study dates: Feb 2007to Aug 2008
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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%.

Who cannot join

None listed.

Trial locations and contacts

82 sites in 2 countries.

Country

City, postcode or hospital

82 sites in 2 countries

United States76 sites

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

Other trials in United States

Canada6 sites

Recherche Invascor Inc
Longueuil, Quebec, J4N 1E1
Alpha Medical Research Inc.
Mississauga, Ontario, L5A 3V4
Hopital du Sacre-Coeur de Montreal
Montreal, Quebec, H4J 1C5
Alexander Medical Innovations Inc.
Niagara Falls, Ontario, L2G 1J4
Allergy and Asthma Research Centre
Ottawa, Ontario, K1Y 4G2
CIC Mauricie Inc.
Trois-Rivières, Quebec, G8T 7A1

Other trials in Canada

About this study

Official title: 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.

Conditions: Asthma
Being tested: IMA-638, placebo
Medical subject headings: Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

IMA-638Biological
SC Injection, 12 weeks
IMA-638Biological
SC Injection, 12 weeks
placeboOther
placebo

Study groups in NCT00425061
Study group	Role	What they receive
1	Experimental	Not described Receives: Biological: IMA-638
2	Experimental	Not described Receives: Biological: IMA-638
3	Placebo comparator	Not described Receives: Other: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: Baseline, Day 112

Secondary outcomes (19)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, Day 8, 28, 56, 84, 112
Percentage of Participants Who Required Treatment With Systemic Steroids for Clinical Exacerbation of Asthma - Stage 1
Measured: Baseline up to Day 112
Percentage of Participants Who Required Treatment With Systemic Steroids for Clinical Exacerbation of Asthma - Stage 2/3
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, Day 8, 28, 56, 84, 112
Blood Eosinophils Levels - Stage 1
Measured: Baseline, Day 8, 28, 56, 84, 112
Blood Eosinophils Levels - Stage 2/3
Measured: 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).
Measured: 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).
Measured: Baseline, Day 28, 56, 84, 112
Serum Interleukin-13 (IL-13) Level - Stage 1
Measured: Baseline, Day 8, 28, 56, 84, 112
Serum Interleukin-13 (IL-13) Level - Stage 2/3
Measured: Baseline, Day 8, 28, 56, 84, 112

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2007Aug 2008

First posted22 Jan 2007 (estimated)
Study startFeb 2007
Primary completionAug 2008
Study completionAug 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for AsthmaStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 159 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00425061
Sponsor's protocol ID: 3174K1-201
Other IDs: B2421007
Status last verified: Jan 2015
First submitted: 18 Jan 2007
Last updated: 14 Jan 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Asthma trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 2 Study Conducted Sequentially With 3 Doses Of Ima-638 Administered Sc.
ClinicalTrials.gov ID: NCT00425061
Acronym / sponsor ID: 3174K1-201
Conditions: Asthma
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 159 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Feb 2007
Primary completion: Aug 2008 (actual)
Study completion: Aug 2008 (actual)
First posted: 22 Jan 2007 (estimated)
Results: Posted 14 Jan 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
1	Experimental	Biological: IMA-638
2	Experimental	Biological: IMA-638
3	Placebo comparator	Other: placebo

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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%.

Key exclusion criteria (0 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
IMA-638SC Injection, 12 weeks	Biological	1
IMA-638SC Injection, 12 weeks	Biological	2
placeboplacebo	Other	3

Primary outcome

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

19 secondary outcomes

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
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
Change From Baseline in Airway Hyper-reactivity at Day 28 and 112
Time frame: 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
Time frame: 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
Time frame: Baseline, Day 8, 28, 56, 84, 112
Percentage of Participants Who Required Treatment With Systemic Steroids for Clinical Exacerbation of Asthma - Stage 1
Time frame: Baseline up to Day 112
Percentage of Participants Who Required Treatment With Systemic Steroids for Clinical Exacerbation of Asthma - Stage 2/3
Time frame: Baseline up to Day 112
Mean Number of Puffs of Rescue Medication Used - Stage 1
Time frame: Day 8, 28, 56, 84, 89, 91, 94, 98, 112
Mean Number of Puffs of Rescue Medication Used - Stage 2/3
Time frame: Day 8, 28, 56, 84, 89, 91, 94, 98, 112
Forced Vital Capacity (FVC) - Stage 1
Time frame: Baseline, Day 8, 28, 56, 84, 112
Forced Vital Capacity (FVC) - Stage 2/3
Time frame: Baseline, Day 8, 28, 56, 84, 112
Forced Mid-Expiratory Flow Rate 25 Percent (%) to 75% (FEF25-75) - Stage 1
Time frame: Baseline, Day 8, 28, 56, 84, 112
Forced Mid-Expiratory Flow Rate 25 Percent (%) to 75% (FEF25-75) - Stage 2/3
Time frame: Baseline, Day 8, 28, 56, 84, 112
Blood Eosinophils Levels - Stage 1
Time frame: Baseline, Day 8, 28, 56, 84, 112
Blood Eosinophils Levels - Stage 2/3
Time frame: Baseline, Day 8, 28, 56, 84, 112
Log 10-transformed Serum Total Immunoglobulin E (IgE) Levels - Stage 1
Time frame: Baseline, Day 28, 56, 84, 112
Log 10-transformed Serum Total Immunoglobulin E (IgE) Levels - Stage 2/3
Time frame: Baseline, Day 28, 56, 84, 112
Serum Interleukin-13 (IL-13) Level - Stage 1
Time frame: Baseline, Day 8, 28, 56, 84, 112
Serum Interleukin-13 (IL-13) Level - Stage 2/3
Time frame: Baseline, Day 8, 28, 56, 84, 112

Results and safety

Results posted to the registry on 14 Jan 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
IMA-638 0.2 mg/kg: Stage 1	16	14
IMA-638 0.6 mg/kg: Stage 1	17	15
IMA-638 2 mg/kg: Stage-1	16	16
Placebo: Stage 1	16	14
IMA-638 200 mg: Stage 2 and 3	45	19
IMA-638 75 mg: Stage 3	4	0
Placebo: Stage 2 and 3	45	26

Primary outcome: Change From Baseline in Morning (Ante Meridiem) Peak Expiratory Flow Rate (AM PEFR) at Day 112 - Stage 1

Time frame: Baseline, Day 112. Mean (Standard Deviation). Unit: liter per minute (L/min)

Measure	IMA-638 0.2 mg/kg: Stage 1 n = 16	IMA-638 0.6 mg/kg: Stage 1 n = 17	IMA-638 2 mg/kg: Stage-1 n = 16	Placebo: Stage 1 n = 16
Baseline	286.4 (67.6)	297.6 (55.4)	343.5 (91.8)	291.5 (64.7)
Change at Day 112	21.1 (40.9)	3.4 (53.6)	7.6 (38.1)	11.8 (37.5)

Population analysed: mITT population (Stage 1) included all randomized participants who received at least 1 dose administration of the test article in Stage 1. Last observation carried forward (LOCF) method was used to impute missing values.

Primary outcome: Change From Baseline in Morning (Ante Meridiem) Peak Expiratory Flow Rate (AM PEFR) at Day 112 - Stage 2/3

Time frame: Baseline, Day 112. Mean (Standard Deviation). Unit: L/min

Measure	IMA-638 200 mg: Stage 2 and 3 n = 45	IMA-638 75 mg: Stage 3 n = 4	Placebo: Stage 2 and 3 n = 45
Baseline (n=42, 4, 45)	329.3 (81.7)	348.6 (39.9)	330.4 (89.5)
Change at Day 112 (n=45, 4, 45)	6.8 (42.9)	18.8 (30.7)	7.6 (48.9)

IMA-638 200 mg: Stage 2 and 3 vs Placebo: Stage 2 and 3: Least squares (LS) mean difference: -5.2 (95% CI -25.6 to 15.2), p = 0.612, ANCOVA

Population analysed: mITT population (Stage 2 and 3) included all randomized participants who received at least 1 dose administration of the test article in Stage 2 and 3. LOCF method was used to impute missing values. "n" signifies those participants who were evaluated for this measure at the specified time point for each arm.

19 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
IMA-638 0.2 mg/kg: Stage 1	0 of 16 (0%)	13 of 16 (81.3%)	Not reported
IMA-638 0.6 mg/kg: Stage 1	1 of 17 (5.9%)	12 of 17 (70.6%)	Not reported
IMA-638 2 mg/kg: Stage-1	2 of 16 (12.5%)	11 of 16 (68.8%)	Not reported
Placebo: Stage 1	1 of 16 (6.3%)	10 of 16 (62.5%)	Not reported
IMA-638 200 mg: Stage 2 and 3	2 of 45 (4.4%)	27 of 45 (60%)	Not reported
IMA-638 75 mg: Stage 3	0 of 4 (0%)	1 of 4 (25%)	Not reported
Placebo: Stage 2 and 3	0 of 45 (0%)	26 of 45 (57.8%)	Not reported

Limitations and caveats (from the sponsor): The study was stopped early due to futility of the interim efficacy analysis results. Hence, only safety results and key efficacy results were presented for this study.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

82 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing IMA-638 in people with Asthma, run by Pfizer at 82 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 82 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Jan 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Morning (Ante Meridiem) Peak Expiratory Flow Rate (AM PEFR) at Day 112 - Stage 1 (time frame: Baseline, Day 112). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00425061.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2015.