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

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00425061
First received: January 18, 2007
Last updated: July 6, 2009
Last verified: July 2009
  Purpose

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


Condition Intervention Phase
Asthma
Biological: IMA-638
Other: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • The change from baseline to day 112 in AM peak expiratory flow rate (PEFR). [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 300
Study Start Date: January 2007
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Biological: IMA-638
SC Injection, 12 weeks
Experimental: 2 Biological: IMA-638
SC Injection, 12 weeks
Placebo Comparator: 3 Other: placebo
placebo

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 corticosteriods (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%.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00425061

  Show 100 Study Locations
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided

Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00425061     History of Changes
Other Study ID Numbers: 3174K1-201
Study First Received: January 18, 2007
Last Updated: July 6, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on April 17, 2014