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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.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00048022
First received: October 24, 2002
Last updated: June 15, 2017
Last verified: February 2017
  Purpose
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)
  Eligibility

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 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
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 ClinicalTrials.gov identifier: NCT00048022

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

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov 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:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on July 27, 2017