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

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: October 24, 2002
Last updated: June 16, 2017
Last verified: February 2017
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 Intervention Phase
Asthma Drug: Dual Integrin Antagonist Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment

Further study details as provided by Hoffmann-La Roche:

Actual Study Start Date: October 25, 2002
Study Completion Date: February 2, 2004
Primary Completion Date: February 2, 2004 (Final data collection date for primary outcome measure)

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

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
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 identifier: NCT00048009

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

Responsible Party: Hoffmann-La Roche Identifier: NCT00048009     History of Changes
Other Study ID Numbers: BA16631
Study First Received: October 24, 2002
Last Updated: June 16, 2017 processed this record on August 18, 2017