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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: April 11, 2014
Last verified: April 2014

January 18, 2007
April 11, 2014
February 2007
August 2008   (final data collection date for primary outcome measure)
The change from baseline to day 112 in AM peak expiratory flow rate (PEFR). [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Percent change in pre-beta-agonist FEV1 (L) from baseline; Change in AM peak expiratory flow rate (PEFR); Change in airway hyperreactivity (PC20); Change in ACQ-5 score.
Complete list of historical versions of study NCT00425061 on ClinicalTrials.gov Archive Site
Percentage change in pre-beta-agonist FEV1 (L) from baseline; Change in airway hyperreactivity (PC20); Change in ACQ-5 score; Rate of clinical exacerbation-asthma worsening requiring treatment with systemic steroids; Rescue beta-agonist use; FVC; FEF25 [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
Rate of clinical exacerbation (asthma worsening requiring treatment with systemic steroids); Rescue beta-agonist use; FVC; FEF25-75; Blood eosinophils; Total IgE level; Serum IL-13 level.
Not Provided
Not Provided
 
Study Evaluating the Effect of IMA-638 in Subjects With Persistent Asthma
A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of 3 Dose Levels of IMA-638 in Subjects With Persistent Asthma

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
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)
  • 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%.
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00425061
3174K1-201, B2421007
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Pfizer
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP