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

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: October 24, 2002
Last updated: June 15, 2017
Last verified: February 2017
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.

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 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00048022

  Show 60 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche Identifier: NCT00048022     History of Changes
Other Study ID Numbers: BA16630
Study First Received: October 24, 2002
Last Updated: June 15, 2017

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases processed this record on September 21, 2017