Pilot Study in Patients With Symptomatic Steroid-Naive Asthma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Facet Biotech
ClinicalTrials.gov Identifier:
NCT00024544
First received: September 19, 2001
Last updated: March 6, 2012
Last verified: March 2012

September 19, 2001
March 6, 2012
August 2001
February 2003   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00024544 on ClinicalTrials.gov Archive Site
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Pilot Study in Patients With Symptomatic Steroid-Naive Asthma
A Phase I/II, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Pilot Study of SB 240683 in Patients With Symptomatic Steroid-Naive Asthma

The purpose of the study is to evaluate an investigational medication to treat chronic asthma. The research is being conducted at 20 clinical research sites in the US and is open to both men and women ages 18 to 70 years. Participants in the study will have a number of visits to a research site over an 8-month period. All study-related care and medication is provided to qualified participants at no cost. This includes all visits, examinations and laboratory work.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Asthma
Drug: anti-IL-4 monoclonal antibody (pascolizumab)
Not Provided
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
February 2003
February 2003   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • At least a 6-month history of asthma
  • No use of inhaled, oral or injectable steroids for at least 1 month prior to enrollment

Exclusion Criteria:

  • Patients with > 10 pack years of smoking history or smoking within 12 months of study enrollment
  • No significant disease other than asthma
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00024544
683-803
Not Provided
Facet Biotech
Facet Biotech
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Not Provided
Facet Biotech
March 2012

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