A Safety and Efficacy Study of Inhaled R940343 in Patients With Mild to Moderate Asthma

NCT ID: NCT01591044

Last Updated: 2016-09-29

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

301 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2013-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to determine the safety, efficacy and tolerability of R940343 in the treatment of mild to moderate asthma.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The study is a multi-center, randomized, double-blind, placebo-controlled, parallel group study comparing 2 doses of inhaled R343 bid to placebo over 8 weeks in patients with mild to moderate allergic asthma. Patients who meet specific inclusion and exclusion criteria after an initial screening evaluation and a single-blind, run-in period will be randomized to receive either R343 or placebo.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Asthma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

R940343 2mg, 2 puffs bid

R343 2mg, 2 puffs bid

Group Type ACTIVE_COMPARATOR

R940343 2mg

Intervention Type DRUG

R343 2mg, 2 puffs bid

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

1 puff bid or 2 puffs bid

R940343 1mg, 1 puff bid

R343 1mg, 1 puff bid

Group Type ACTIVE_COMPARATOR

R940343 1mg

Intervention Type DRUG

R343 1mg, 1 puff bid

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Placebo

1 puff bid or 2 puffs bid

Intervention Type DRUG

R940343 1mg

R343 1mg, 1 puff bid

Intervention Type DRUG

R940343 2mg

R343 2mg, 2 puffs bid

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

R343 R343

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Clinical history of asthma
* Ability to perform spirometry

Exclusion Criteria

* Chronic obstructive pulmonary disease or bronchiectasis
* Upper or lower respiratory infection
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Rigel Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Elliott Grossbard, MD

Role: STUDY_DIRECTOR

Rigel Pharmaceuticals,Inc.

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

California Research Medical Group, Inc

Fullerton, California, United States

Site Status

Allergy Medical Clinic Research Division

Los Angeles, California, United States

Site Status

California Allergy & Asthma Medical Group, INC

Los Angeles, California, United States

Site Status

Southern California Institute for Respiratory Diseases, Inc.

Los Angeles, California, United States

Site Status

Allergy & Asthma Associates of Southern California

Mission Viejo, California, United States

Site Status

CHOC PSF, AMC, Division of Allergy, Asthma & Immunology

Orange, California, United States

Site Status

Peninsula Research Associates

Rolling Hills Estates, California, United States

Site Status

Allergy Associates Medical Group. Inc.

San Diego, California, United States

Site Status

Allergy & Asthma Med Group/Research Center

San Diego, California, United States

Site Status

Allergy & Asthma Associates of Santa Clara Valley

San Jose, California, United States

Site Status

Bensch Research Associates

Stockton, California, United States

Site Status

Colorado Allergy and Asthma Clinic, PC

Centennial, Colorado, United States

Site Status

Asthma & Allergy Associates, PC

Colorado Springs, Colorado, United States

Site Status

National Jewish Health

Denver, Colorado, United States

Site Status

Colorado Allergy & Asthma Centers, PC

Denver, Colorado, United States

Site Status

Florida Center for Allergy & Asthma Research

Aventura, Florida, United States

Site Status

Accelovance

Melbourne, Florida, United States

Site Status

Sarasota Clinical Research

Sarasota, Florida, United States

Site Status

Georgia Pollens Clinical Research Centers, Inc.

Albany, Georgia, United States

Site Status

Idaho Allergy DBA Idaho Research

Eagle, Idaho, United States

Site Status

Sneeze, Wheeze & Itch Associates

Normal, Illinois, United States

Site Status

Chesapeake Clinical Research, Inc.

Baltimore, Maryland, United States

Site Status

Northeast Medical Research Associates, Inc.

North Dartmouth, Massachusetts, United States

Site Status

Respiratory Medicine Researh Institute of Michigan

Ypsilanti, Michigan, United States

Site Status

Clinical Research Institute

Minneapolis, Minnesota, United States

Site Status

Clinical Research Institute, Inc.

Plymouth, Minnesota, United States

Site Status

Clinical Research of The Ozarks, Inc.

Columbia, Missouri, United States

Site Status

The Clinical Research Center, LLC

St Louis, Missouri, United States

Site Status

Clinical Research Group of Montana PLLC

Bozeman, Montana, United States

Site Status

The Asthma & Allergy Center

Bellevue, Nebraska, United States

Site Status

Atlantic Research Center, LLC

Ocean City, New Jersey, United States

Site Status

Princeton Center for Clinical Research

Skillman, New Jersey, United States

Site Status

Allergy Consultants, PA

Verona, New Jersey, United States

Site Status

New York Pulmonary Associates, P.C.

New York, New York, United States

Site Status

Allergy Asthma Immunology of Rochester (AAIR)

Rochester, New York, United States

Site Status

Peters Medical Research

High Point, North Carolina, United States

Site Status

North Carolina Clinical Research

Raleigh, North Carolina, United States

Site Status

New Horizons Clinical Research

Cincinnati, Ohio, United States

Site Status

Allergy, Asthma & Clinical Research Center

Oklahoma City, Oklahoma, United States

Site Status

Allergy & Asthma Research Group

Eugene, Oregon, United States

Site Status

Clinical Research Inst. of Southern Oregon, PC

Medford, Oregon, United States

Site Status

Allergy Associates Research Center

Portland, Oregon, United States

Site Status

Allergy & Clinical Immunology Associates

Pittsburgh, Pennsylvania, United States

Site Status

National Allergy, Asthma and Uticaria Center of Charleston

Charleston, South Carolina, United States

Site Status

Pharmaceutical Research & Consulting, Inc.

Dallas, Texas, United States

Site Status

Western Sky Medical Research, Inc.

El Paso, Texas, United States

Site Status

Live Oak Allergy & Asthma Clinic

Live Oak, Texas, United States

Site Status

Allergy & Asthma Care of Waco, PA

Waco, Texas, United States

Site Status

Allergy Asthma Research Institute

Waco, Texas, United States

Site Status

ASTHMA, Inc.

Seattle, Washington, United States

Site Status

MultiCare Pulmonary Specialists

Tacoma, Washington, United States

Site Status

Joseph Greenbaum, MD

Hamilton, Ontario, Canada

Site Status

Cheema Research, Inc.

Missassauga, Ontario, Canada

Site Status

Niagara Clinical Research

Niagara Falls, Ontario, Canada

Site Status

Ottawa Allergy Research Corp

Ottawa, Ontario, Canada

Site Status

Pulmonary Care Clinic

Toronto, Ontario, Canada

Site Status

Primary Care Lung Clinic

Toronto, Ontario, Canada

Site Status

Dynamik Research, Inc.

Pointe-Claire, Quebec, Canada

Site Status

Centre De recherche Appliquee en Allergie DeQuebec

Québec, Quebec, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Canada

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

C-940343-004

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

A Phase Ib Study of RC1416 Injection
NCT06911866 RECRUITING PHASE1
Study in Patients With Asthma
NCT00215410 COMPLETED PHASE2
Bosentan for Poorly Controlled Asthma
NCT00815347 TERMINATED PHASE2