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

August 5, 2016 updated by: Rigel Pharmaceuticals

A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Doses of Inhaled R940343 in Patients With Mild to Moderate Allergic Asthma

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

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.

Detailed Description

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.

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

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
301

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

  • Canada
      • Quebec, Canada, G1V 4M6
        • Centre De recherche Appliquee en Allergie DeQuebec
    • Ontario
      • Hamilton, Ontario, Canada, L8N 1Y2
        • Joseph Greenbaum, MD
      • Missassauga, Ontario, Canada, L5A 3V4
        • Cheema Research, Inc.
      • Niagara Falls, Ontario, Canada, L2G 1J4
        • Niagara Clinical Research
      • Ottawa, Ontario, Canada, K1Y 4G2
        • Ottawa Allergy Research Corp
      • Toronto, Ontario, Canada, M6H 3M2
        • Primary Care Lung Clinic
      • Toronto, Ontario, Canada, M5G 1N8
        • Pulmonary Care Clinic
    • Quebec
      • Pointe-Claire, Quebec, Canada, H9R 3J1
        • Dynamik Research, Inc.
  • United States
    • California
      • Fullerton, California, United States, 92835
        • California Research Medical Group, Inc
      • Los Angeles, California, United States, 90048
        • Southern California Institute for Respiratory Diseases, Inc.
      • Los Angeles, California, United States, 90025
        • Allergy Medical Clinic Research Division
      • Los Angeles, California, United States, 90025
        • California Allergy & Asthma Medical Group, INC
      • Mission Viejo, California, United States, 92691
        • Allergy & Asthma Associates of Southern California
      • Orange, California, United States, 92868
        • CHOC PSF, AMC, Division of Allergy, Asthma & Immunology
      • Rolling Hills Estates, California, United States, 90274
        • Peninsula Research Associates
      • San Diego, California, United States, 92120
        • Allergy Associates Medical Group. Inc.
      • San Diego, California, United States, 92123
        • Allergy & Asthma Med Group/Research Center
      • San Jose, California, United States, 95117
        • Allergy & Asthma Associates of Santa Clara Valley
      • Stockton, California, United States, 95207
        • Bensch Research Associates
    • Colorado
      • Centennial, Colorado, United States, 80112
        • Colorado Allergy and Asthma Clinic, PC
      • Colorado Springs, Colorado, United States, 80907
        • Asthma & Allergy Associates, PC
      • Denver, Colorado, United States, 80206
        • National Jewish Health
      • Denver, Colorado, United States, 80230
        • Colorado Allergy & Asthma Centers, PC
    • Florida
      • Aventura, Florida, United States, 33180
        • Florida Center for Allergy & Asthma Research
      • Melbourne, Florida, United States, 32935
        • Accelovance
      • Sarasota, Florida, United States, 34233
        • Sarasota Clinical Research
    • Georgia
      • Albany, Georgia, United States, 31707
        • Georgia Pollens Clinical Research Centers, Inc.
    • Idaho
      • Eagle, Idaho, United States, 83616
        • Idaho Allergy DBA Idaho Research
    • Illinois
      • Normal, Illinois, United States, 61761
        • Sneeze, Wheeze & Itch Associates
    • Maryland
      • Baltimore, Maryland, United States, 21236
        • Chesapeake Clinical Research, Inc.
    • Massachusetts
      • North Dartmouth, Massachusetts, United States, 02747
        • Northeast Medical Research Associates, Inc.
    • Michigan
      • Ypsilanti, Michigan, United States, 48197
        • Respiratory Medicine Researh Institute of Michigan
    • Minnesota
      • Minneapolis, Minnesota, United States, 55402
        • Clinical Research Institute
      • Plymouth, Minnesota, United States, 55441
        • Clinical Research Institute, Inc.
    • Missouri
      • Columbia, Missouri, United States, 65203
        • Clinical Research of The Ozarks, Inc.
      • St Louis, Missouri, United States, 63141
        • The Clinical Research Center, LLC
    • Montana
      • Bozeman, Montana, United States, 59718
        • Clinical Research Group of Montana PLLC
    • Nebraska
      • Bellevue, Nebraska, United States, 68123
        • The Asthma & Allergy Center
    • New Jersey
      • Ocean, New Jersey, United States, 07712
        • Atlantic Research Center, LLC
      • Skillman, New Jersey, United States, 08558
        • Princeton Center For Clinical Research
      • Verona, New Jersey, United States, 07044
        • Allergy Consultants, PA
    • New York
      • New York, New York, United States, 10016
        • New York Pulmonary Associates, P.C.
      • Rochester, New York, United States, 14618
        • Allergy Asthma Immunology of Rochester (AAIR)
    • North Carolina
      • High Point, North Carolina, United States, 27262
        • Peters Medical Research
      • Raleigh, North Carolina, United States, 27607
        • North Carolina Clinical Research
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • New Horizons Clinical Research
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • Allergy, Asthma & Clinical Research Center
    • Oregon
      • Eugene, Oregon, United States, 97401-7721
        • Allergy & Asthma Research Group
      • Medford, Oregon, United States, 97504
        • Clinical Research Inst. of Southern Oregon, Pc
      • Portland, Oregon, United States, 97202
        • Allergy Associates Research Center
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15241
        • Allergy & Clinical Immunology Associates
    • South Carolina
      • Charleston, South Carolina, United States, 29406
        • National Allergy, Asthma and Uticaria Center of Charleston
    • Texas
      • Dallas, Texas, United States, 75231
        • Pharmaceutical Research & Consulting, Inc.
      • El Paso, Texas, United States, 79903
        • Western Sky Medical Research, Inc.
      • Live Oak, Texas, United States, 78233
        • Live Oak Allergy & Asthma Clinic
      • Waco, Texas, United States, 76712
        • Allergy Asthma Research Institute
      • Waco, Texas, United States, 76712
        • Allergy & Asthma Care of Waco, PA
    • Washington
      • Seattle, Washington, United States, 98115
        • ASTHMA, Inc.
      • Tacoma, Washington, United States, 98405
        • MultiCare Pulmonary Specialists

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:

  • Clinical history of asthma
  • Ability to perform spirometry

Exclusion Criteria:

  • Chronic obstructive pulmonary disease or bronchiectasis
  • Upper or lower respiratory infection

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
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
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.
Placebo Comparator: Placebo
Drug: Placebo
1 puff bid or 2 puffs bid
Active Comparator: R940343 2mg, 2 puffs bid
R343 2mg, 2 puffs bid
Drug: R940343 2mg
R343 2mg, 2 puffs bid
Other Names:
  • R343
Active Comparator: R940343 1mg, 1 puff bid
R343 1mg, 1 puff bid
Drug: R940343 1mg
R343 1mg, 1 puff bid
Other Names:
  • R343

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in FEV1
Time Frame: Baseline and Week 8
Change from baseline in pre-BD FEV1 (% predicted) at Week 8.
Baseline and Week 8

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.
Rigel Pharmaceuticals

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Elliott Grossbard, MD, Rigel Pharmaceuticals, Inc.

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

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.
July 1, 2012

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.
July 1, 2013

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.
July 1, 2013

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).
April 30, 2012

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.
May 2, 2012

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.
May 3, 2012

Study Record Updates

Last Update Posted (Estimate)

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.
September 29, 2016

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.
August 5, 2016

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.
August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

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.
  • C-940343-004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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