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

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NCT00425061

Last updated on May 10, 2018
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FOR MORE INFORMATION
Study Location
Alabama Allergy and Asthma Center
Birmingham, Alabama, 35209 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Asthma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-80 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
NCT00425061
Pfizer
Completed
Study Evaluating the Effect of IMA-638 in Subjects With Persistent Asthma

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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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Asthma
  • Biological: IMA-638
    SC Injection, 12 weeks
  • Other: placebo
    placebo
  • Experimental: 1
    Intervention: Biological: IMA-638
  • Experimental: 2
    Intervention: Biological: IMA-638
  • Placebo Comparator: 3
    Intervention: Other: placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
159
August 2008
August 2008   (Final data collection date for primary outcome measure)

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:
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
 
 
NCT00425061
3174K1-201
B2421007 ( Other Identifier: Alias Study Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2015

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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