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

June 16, 2017 updated by: Hoffmann-La Roche
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Adelaide, Australia, 5000
      • Brisbane, Australia, 4102
      • Melbourne, Australia, 3050
      • Perth, Australia, 6009
      • Sydney, Australia, 2139
      • Woodville, Australia, 5011
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
    • Ontario
      • Hamilton, Ontario, Canada, L8N 4A6
      • Toronto, Ontario, Canada, M5S 2A5
      • Toronto, Ontario, Canada, M6H 3M2
    • Quebec
      • Montreal, Quebec, Canada, H4J 1C5
      • Quebec City, Quebec, Canada, O1V 4G5
  • Mexico
      • Chihuahua, Mexico, 31000
      • Guadalajara, Mexico, 44600
      • Merida, Mexico
      • Mexico, Mexico, 14080
      • Mexico City, Mexico, 06700
      • Mexico City, Mexico, 14050
      • Mexico, Df, Mexico, 06720
      • Monterrey, Mexico, 64000
      • Monterrey, Mexico, 64710
      • Puebla, Mexico, 72000
  • Puerto Rico
      • Ponce, Puerto Rico, 00732
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85251
    • California
      • Huntington Beach, California, United States, 92647
      • Long Beach, California, United States, 90806
      • Los Angeles, California, United States, 90025
      • Los Angeles, California, United States, 90095-1690
      • Palmdale, California, United States, 93551
      • San Diego, California, United States, 92103
      • San Diego, California, United States, 92123
      • San Diego, California, United States, 92120
      • San Jose, California, United States, 95128
      • Walnut Creek, California, United States, 94598
    • Colorado
      • Denver, Colorado, United States, 80206
      • Denver, Colorado, United States, 80230
      • Louisville, Colorado, United States, 80027
      • Wheat Ridge, Colorado, United States, 80033
    • Connecticut
      • Hartford, Connecticut, United States, 06106
    • Florida
      • Tallahassee, Florida, United States, 32308
      • Tamarac, Florida, United States, 33321
      • Tampa, Florida, United States, 33613
      • Tampa, Florida, United States, 33609
    • Georgia
      • Atlanta, Georgia, United States, 30309
      • Savannah, Georgia, United States, 31406
    • Illinois
      • Chicago, Illinois, United States, 60637-1470
      • Normal, Illinois, United States, 61761
      • River Forest, Illinois, United States, 60305
    • Indiana
      • Indianapolis, Indiana, United States, 46208
    • Iowa
      • Iowa City, Iowa, United States, 52240
    • Kansas
      • Lenexa, Kansas, United States, 66219
    • Louisiana
      • Metairie, Louisiana, United States, 70006
    • Massachusetts
      • North Dartmouth, Massachusetts, United States, 02745
    • Minnesota
      • Minneapolis, Minnesota, United States, 55402
    • Missouri
      • Saint Louis, Missouri, United States, 63141
    • Montana
      • Missoula, Montana, United States, 59804
    • Nebraska
      • Omaha, Nebraska, United States, 68114
    • Nevada
      • Las Vegas, Nevada, United States, 89104
    • New Jersey
      • Cherry Hill, New Jersey, United States, 08003
      • Princeton, New Jersey, United States, 08540
      • Teaneck, New Jersey, United States, 07666
    • New York
      • Farmingdale, New York, United States, 11735
      • Rochester, New York, United States, 14618
      • Rockville Centre, New York, United States, 11570
    • North Carolina
      • Elizabeth City, North Carolina, United States, 27909
    • Ohio
      • Canton, Ohio, United States, 44718
      • Cincinnati, Ohio, United States, 45231
    • Oregon
      • Medford, Oregon, United States, 97504
      • Portland, Oregon, United States, 97213
    • Pennsylvania
      • Easton, Pennsylvania, United States, 18045
      • Philadelphia, Pennsylvania, United States, 19140
      • Philadelphia, Pennsylvania, United States, 19115
      • Upland, Pennsylvania, United States, 19013
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
    • South Carolina
      • Charleston, South Carolina, United States, 29425
      • Charleston, South Carolina, United States, 29407
    • Texas
      • Austin, Texas, United States, 78750
      • Dallas, Texas, United States, 75231
      • Dallas, Texas, United States, 75240
      • El Paso, Texas, United States, 79925
      • San Antonio, Texas, United States, 78229
      • Sugar Land, Texas, United States, 77478
    • Utah
      • Murray, Utah, United States, 84107
    • Washington
      • Kirkland, Washington, United States, 98034
      • Seattle, Washington, United States, 98105
      • Spokane, Washington, United States, 99202
      • Tacoma, Washington, United States, 98405
      • Wenatchee, Washington, United States, 98801
    • West Virginia
      • Morgantown, West Virginia, United States, 26505
    • Wisconsin
      • Madison, Wisconsin, United States, 53792-9988
      • Milwaukee, Wisconsin, United States, 53209

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 25, 2002

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 2, 2004

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 2, 2004

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 24, 2002

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2002

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 25, 2002

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 19, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BA16631

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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