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Evaluation of Various Doses of Ro 27-2771 (Test Drug) in Asthmatic Patients Not Treated With Inhaled Corticosteroids

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ClinicalTrials.gov Identifier: NCT00048009
Recruitment Status : Completed
First Posted : October 25, 2002
Last Update Posted : June 19, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to determine the appropriate dose of Ro 27-2441 (test drug) to be used in future studies, assess the efficacy and safety, and the anti-inflammatory action of the test drug in the treatment of asthmatic patients who are not currently receiving chronic therapy with corticosteroids. The research is being conducted at up to 80 clinical research sites in the US, Mexico, and Canada. Study participants will have a number of visits to a research site over approximately a 4-month period.

Condition or disease Intervention/treatment Phase
Asthma Drug: Dual Integrin Antagonist Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Actual Study Start Date : October 25, 2002
Primary Completion Date : February 2, 2004
Study Completion Date : February 2, 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Persistent asthma for more than one year
  • Current treatment for asthma with short acting inhaled beta 2 agonists (such as albuterol) only
  • In good health ad 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 one month after discontinuing therapy

Exclusion Criteria:

  • Asthma necessitating treatment with inhaled corticosteroids for at least one month before the start of the study
  • History of severe asthma necessitating the use of oral/injectable corticosteroids within the last 2 months and/and or two bursts in the last year
  • Undergoing allergy shots unless on a stable maintenance dose for three 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 one month of the start of the study
  • Current tobacco use
  • 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00048009


  Show 91 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00048009     History of Changes
Other Study ID Numbers: BA16631
First Posted: October 25, 2002    Key Record Dates
Last Update Posted: June 19, 2017
Last Verified: February 2017