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
  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 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 ]

Enrollment: 159
Study Start Date: February 2007
Study Completion Date: August 2008
Primary Completion Date: August 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 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%.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00425061

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

No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00425061     History of Changes
Other Study ID Numbers: 3174K1-201, B2421007
Study First Received: January 18, 2007
Last Updated: April 11, 2014
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 July 29, 2014