AsthmaPhase 2SITARNCT01591044

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

A Phase 2 study testing R940343 1mg and R940343 2mg in people with Asthma, run by Rigel Pharmaceuticals at 59 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

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

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Asthma
What is being tested?: R940343 1mg and R940343 2mg
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 301 participants
Where: 59 sitesin 2 countries
Study dates: Jul 2012to Jul 2013
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Clinical history of asthma
Ability to perform spirometry

Who cannot join

Chronic obstructive pulmonary disease or bronchiectasis
Upper or lower respiratory infection

Trial locations and contacts

59 sites in 2 countries.

Country

City, postcode or hospital

59 sites in 2 countries

United States51 sites

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

Other trials in United States

Canada8 sites

Joseph Greenbaum, MD
Hamilton, Ontario, L8N 1Y2
Cheema Research, Inc.
Missassauga, Ontario, L5A 3V4
Niagara Clinical Research
Niagara Falls, Ontario, L2G 1J4
Ottawa Allergy Research Corp
Ottawa, Ontario, K1Y 4G2
Dynamik Research, Inc.
Pointe-Claire, Quebec, H9R 3J1
Centre De recherche Appliquee en Allergie DeQuebec
Québec, Quebec, G1V 4M6
Pulmonary Care Clinic
Toronto, Ontario, M5G 1N8
Primary Care Lung Clinic
Toronto, Ontario, M6H 3M2

Other trials in Canada

About this study

Official title: 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.

Read the 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.

Conditions: Asthma
Being tested: Placebo, R940343 1mg, R940343 2mg
Medical subject headings: Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PlaceboDrug
1 puff bid or 2 puffs bid
R940343 1mgDrug
Also called R343
R343 1mg, 1 puff bid
R940343 2mgDrug
Also called R343
R343 2mg, 2 puffs bid

Study groups in NCT01591044
Study group	Role	What they receive
R940343 2mg, 2 puffs bid	Active comparator	R343 2mg, 2 puffs bid Receives: Drug: R940343 2mg
Placebo	Placebo comparator	Not described Receives: Drug: Placebo
R940343 1mg, 1 puff bid	Active comparator	R343 1mg, 1 puff bid Receives: Drug: R940343 1mg

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in FEV1
Change from baseline in pre-BD FEV1 (% predicted) at Week 8.
Measured: Baseline and Week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2012Jul 2013

First posted3 May 2012 (estimated)
Study startJul 2012
Primary completionJul 2013
Study completionJul 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for AsthmaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 301 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01591044
Sponsor's protocol ID: C-940343-004
Acronym: SITAR
Status last verified: Aug 2016
First submitted: 30 Apr 2012
Last updated: 29 Sep 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma

All Asthma trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT01591044
Acronym / sponsor ID: SITAR / C-940343-004
Conditions: Asthma
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 301 participants (actual)
Lead sponsor: Rigel PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Jul 2012
Primary completion: Jul 2013 (actual)
Study completion: Jul 2013 (actual)
First posted: 3 May 2012 (estimated)
Results: Posted 29 Sep 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
R940343 2mg, 2 puffs bid	Active comparator	Drug: R940343 2mgR343 2mg, 2 puffs bid
Placebo	Placebo comparator	Drug: Placebo
R940343 1mg, 1 puff bid	Active comparator	Drug: R940343 1mgR343 1mg, 1 puff bid

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Clinical history of asthma
Ability to perform spirometry

Key exclusion criteria (2 listed)

Chronic obstructive pulmonary disease or bronchiectasis
Upper or lower respiratory infection

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Placebo1 puff bid or 2 puffs bid	Drug	Placebo
R940343 1mgAlso: R343R343 1mg, 1 puff bid	Drug	R940343 1mg, 1 puff bid
R940343 2mgAlso: R343R343 2mg, 2 puffs bid	Drug	R940343 2mg, 2 puffs bid

Primary outcome

Change in FEV1
Time frame: Baseline and Week 8
Change from baseline in pre-BD FEV1 (% predicted) at Week 8.

Results and safety

Results posted to the registry on 29 Sep 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
R940343 2mg, 2 Puffs Bid	101	94
Placebo	100	91
R940343 1mg, 1 Puff Bid	100	96

Primary outcome: Change in FEV1

Time frame: Baseline and Week 8. Mean (Standard Deviation). Unit: percentage of change

Measure	R940343 2mg, 2 Puffs Bid n = 101	Placebo n = 100	R940343 1mg, 1 Puff Bid n = 100
Value	-0.40 (8.56)	0.69 (9.31)	-0.59 (8.75)

Population analysed: All efficacy endpoints were analyzed based on the intent to treat population consisting of all randomized patients.

Adverse events

Time frame: The adverse event reporting period begins with the first dose of study drug and ends with the final study follow-up visit (week 9).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
R940343 2mg, 2 Puffs Bid	0 of 101 (0%)	36 of 101 (35.6%)	Not reported
Placebo	0 of 100 (0%)	48 of 100 (48%)	Not reported
R940343 1mg, 1 Puff Bid	0 of 100 (0%)	26 of 100 (26%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Asthma

RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Elliott Grossbard, MD study director

Rigel Pharmaceuticals,Inc.

59 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing R940343 1mg and R940343 2mg in people with Asthma, run by Rigel Pharmaceuticals at 59 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 59 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Sep 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in FEV1 (time frame: Baseline and Week 8). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01591044.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2016.