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Inhaled Corticosteroid Replacement Study - Efficacy and Safety of Ro 27-2441 (Test Drug) in Moderate Persistent Asthma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00048022
Recruitment Status : Completed
First Posted : October 25, 2002
Last Update Posted : June 19, 2017
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date  ICMJE October 24, 2002
First Posted Date  ICMJE October 25, 2002
Last Update Posted Date June 19, 2017
Actual Study Start Date  ICMJE October 25, 2002
Actual Primary Completion Date February 2, 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Inhaled Corticosteroid Replacement Study - Efficacy and Safety of Ro 27-2441 (Test Drug) in Moderate Persistent Asthma
Official Title  ICMJE Not Provided
Brief Summary The primary objective of the study is to evaluate the anti-inflammatory action and safety of Ro 27-2441 (study drug) in asthmatic patients currently taking inhaled corticosteroids. The research is being conducted at up to 40 clinical research sites in the US. Study participants will have a number of visits to a research site over a 4-month period.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Primary Purpose: Treatment
Condition  ICMJE Asthma
Intervention  ICMJE Drug: Dual Integrin Antagonist
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE February 2, 2004
Actual Primary Completion Date February 2, 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Persistent asthma for more than 1 year
  • Currently receiving treatment with a stable dose of inhaled corticosteroids for more than 3 months
  • In good health as demonstrated by medical history and physical exam
  • Negative urine pregnancy test
  • Commitment to use two forms of effective contraception simultaneously throughout the study duration and for 1 month after discontinuing therapy

Exclusion Criteria:

  • Hospitalization for treatment of asthma and/or treatment with oral/injectable corticosteroids within 3 months before the start of the study
  • Undergoing allergy shots unless on a stable maintenance dose for 3 months before the start of the study
  • History of chronic pulmonary diseases other than asthma
  • Treatment of conditions other than asthma with oral corticosteroids within 1 month of the start of the study
  • Current tobacco usage
  • Smoking history of greater than 10 pack-year history of cigarette smoking (number of packs smoked per day times the number of years smoked)
  • History or evidence of drug or alcohol abuse
  • Diagnosis or evidence of an infectious illness within one month of Visit 1
  • Clinically significant diseases as assessed by the study doctor
  • Participation in another clinical study with an experimental drug within one month of start of the study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Puerto Rico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00048022
Other Study ID Numbers  ICMJE BA16630
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hoffmann-La Roche
Study Sponsor  ICMJE Hoffmann-La Roche
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Hoffmann-La Roche
Verification Date February 2017

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