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

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Adelaide, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dual Integrin Antagonist

Drug

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Important dates

Study start: 2002
Primary completion: 2004
Study completion: 2004
First posted: Oct 25, 2002
Registry last updated: Jun 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed