AsthmaPhase 2NCT01561690
A Study of ARRY-502 in Patients With Persistent Asthma
A Phase 2 study testing ARRY-502, CRTh2 antagonist; oral in people with Asthma, run by Pfizer at 43 sites in United States.
Trial summary
This is a Phase 2 study, involving a 6-week treatment period, designed to evaluate the effectiveness of investigational study drug ARRY-502 in treating mild to moderate persistent asthma, and to further evaluate the safety of the drug. Approximately 180 patients from the US will be enrolled in this study. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Asthma
- What is being tested?
- ARRY-502, CRTh2 antagonist; oral
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 184 participants
- Where
- 43 sitesUnited States
- Study dates
- 2 Apr 2012to 10 Jun 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Documented history of bronchial asthma diagnosed at least 6 months prior to study start and prior to the age of 40 years.
- Body mass index (BMI) of 18 to 35 inclusive.
- An ACQ score of ≥ 1.5 at specified time points prior to first dose of study drug.
- A best prebronchodilator FEV1 of 60% to 85% of the predicted normal value and a change in best postbronchodilator FEV1 of ≥ 12% and ≥ 200 mL at specified time points prior to first dose of study drug.
- Additional criteria exist.
Who cannot join
- Evidence of aspirin-sensitive asthma.
- Pre-existing lung disease other than asthma.
- Clinically significant dermatologic, hematological, renal, endocrine, pulmonary (other than asthma), gastrointestinal, cardiovascular, hepatic, neurologic, ophthalmologic, musculoskeletal or immunologic disease (excepting allergic disease and asthma) that is uncontrolled despite treatment or is likely in the opinion of the Investigator to require a change in therapy during the study.
- Patients with any current or past history of cancer within 5 years prior to study start except for treated basal cell or squamous cell carcinomas of the skin, ductal carcinoma in situ of the breast or cervical carcinomas in situ.
- Any history of serious illness requiring hospitalization within 6 months prior to study start.
- Known positive serology for the human immunodeficiency virus (HIV), hepatitis B and/or active hepatitis C.
Show all 11Show fewer
- A positive test for drugs or alcohol, unless the positive drug screen is associated with a prescribed medication and is approved by the Medical Monitor.
- Smoking (tobacco or marijuana) within 6 months prior to study start and/or a smoking history of > 10 packs/year.
- Blood donation of ≥ 1 pint (473 mL) within 8 weeks prior to the first dose of study drug.
- Previous treatment with ARRY-502.
- Additional criteria exist.
Trial locations and contacts
43 sites in 1 country.
43 sites in 1 country
United States43 sites
Tekton Research
Austin, Texas, 78745
Chesapeake Clinical Research Inc
Baltimore, Maryland, 21236
The Asthma & Allergy Center
Bellevue, Nebraska, 68123
Clinical Research Group of Montana
Bozeman, Montana, 59718
Allergy, Respiratory & Sleep Center
Canton, Ohio, 44718
Colorado Allergy and Asthma Center
Centennial, Colorado, 80112
IMMUNOe International Research Centers
Centennial, Colorado, 80112
Bernstein Clinical Research
Cincinnati, Ohio, 45231
Asthma & Allergy Associates PC
Colorado Springs, Colorado, 80909
Pharmaceutical Research & Consulting Inc.
Dallas, Texas, 75231
Idaho Research
Eagle, Idaho, 83616
Western Sky Medical Research Inc
El Paso, Texas, 79903
Allergy Asthma & Sinus Center, S.C.
Greenfield, Wisconsin, 53228
Allergy & Asthma Specialists Medical Group
Huntington Beach, California, 92647
Clinical Neuroscience Solutions
Jacksonville, Florida, 32256
Pulmonary Disease Specialists
Kissimmee, Florida, 34741
Baker Allergy, Asthma & Dermatology Research Center
Lake Oswego, Oregon, 97035
Allergy Medical Clinic - Research Division
Los Angeles, California, 90025
California Allergy & Asthma Med. Group
Los Angeles, California, 90025
Southern California Institute for Respiratory Diseases Inc
Los Angeles, California, 90048
Asthma Allergy & Pulmonary Research
Madison, Wisconsin, 53792
Clinical Research Institute of Southern Oregon
Medford, Oregon, 97504
South Florida Research Trials
Miami, Florida, 33186
Clinical Research Institute
Minneapolis, Minnesota, 55402
Southern California Research
Mission Viejo, California, 92691
Central Texas Health Research
New Braunfels, Texas, 78130
Sneeze, Wheeze & Itch
Normal, Illinois, 61761
Northeast Medical Research Associates
North Dartmouth, Massachusetts, 02747
IPS Research Company
Oklahoma City, Oklahoma, 73103
Allergy Asthma & Clinical Research Center
Oklahoma City, Oklahoma, 73120
University of Pittsburgh Asthma Institute
Pittsburgh, Pennsylvania, 15213
Clinical Research Institute
Plymouth, Minnesota, 55441
North Carolina Clinical Research
Raleigh, North Carolina, 27607
Peninsula Research Associates
Rolling Hills Estates, California, 90274
Sylvana Research Associates
San Antonio, Texas, 78229
Allergy Associates Medical Group
San Diego, California, 92120
Asthma Inc.
Seattle, Washington, 98105
Princeton Center for Clinical Research
Skillman, New Jersey, 08558
Toledo Center for Clinical Research
Sylvania, Ohio, 43560
Allergy & Asthma Diagnostic Treatment Center
Tallahassee, Florida, 32308
Vital Prospects Clinical Research Institute, PC
Tulsa, Oklahoma, 74136
Rocky Mountain Center for Clinical Research
Wheat Ridge, Colorado, 80033
Florida Pulmonary Research Institute
Winter Park, Florida, 32789
About this study
Official title: A Phase 2 Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of ARRY-502 in Adults With Persistent Asthma
This is a Phase 2 study, involving a 6-week treatment period, designed to evaluate the effectiveness of investigational study drug ARRY-502 in treating mild to moderate persistent asthma, and to further evaluate the safety of the drug. Approximately 180 patients from the US will be enrolled in this study.
- Conditions
- Asthma
- Being tested
- ARRY-502, CRTh2 antagonist; oral, Placebo; oral
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARRY-502, CRTh2 antagonist; oralDrug
multiple dose, single schedule
Placebo; oralDrug
matching placebo
| Study group | Role | What they receive |
|---|---|---|
| ARRY-502 | Experimental | Not described Receives: Drug: ARRY-502, CRTh2 antagonist; oral |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo; oral |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the efficacy of the study drug (versus placebo) in terms of prebronchodilator forced expiratory volume in 1 second (FEV1).
Measured: 6 weeks
Secondary outcomes (4)
Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests, vital signs and electrocardiograms.
Measured: 6 weeks
Measure the exposure of study drug in terms of plasma concentrations.
Measured: 6 weeks
Assess the effect of study drug on asthma control in terms of Asthma Control Questionnaire (ACQ) score, the number of symptom-free days and the number of weekly short-acting beta (ß) 2 agonist (SABA) metered dose inhaler (MDI) actuations.
Measured: 6 weeks
Assess the effect of study drug on respiratory function in terms of FEV1, forced vital capacity (FVC), forced expiratory flow (FEF) and peak expiratory flow (PEF).
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2012 (estimated)
- Study start2 Apr 2012
- Primary completion31 May 2013
- Study completion10 Jun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- 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
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01561690
- Sponsor's protocol ID
- ARRAY-502-201
- Other IDs
- C4681001
- Status last verified
- Oct 2023
- First submitted
- 21 Mar 2012
- Last updated
- 30 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of ARRY-502 in Adults With Persistent Asthma
- ClinicalTrials.gov ID
- NCT01561690
- Acronym / sponsor ID
- ARRAY-502-201
- Conditions
- Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 2 Apr 2012 (actual)
- Primary completion
- 31 May 2013 (actual)
- Study completion
- 10 Jun 2013 (actual)
- First posted
- 23 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 2 study, involving a 6-week treatment period, designed to evaluate the effectiveness of investigational study drug ARRY-502 in treating mild to moderate persistent asthma, and to further evaluate the safety of the drug. Approximately 180 patients from the US will be enrolled in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARRY-502 | Experimental | Drug: ARRY-502, CRTh2 antagonist; oral |
| Placebo | Placebo comparator | Drug: Placebo; oral |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Documented history of bronchial asthma diagnosed at least 6 months prior to study start and prior to the age of 40 years.
- Body mass index (BMI) of 18 to 35 inclusive.
- An ACQ score of ≥ 1.5 at specified time points prior to first dose of study drug.
- A best prebronchodilator FEV1 of 60% to 85% of the predicted normal value and a change in best postbronchodilator FEV1 of ≥ 12% and ≥ 200 mL at specified time points prior to first dose of study drug.
- Additional criteria exist.
Key exclusion criteria (11 listed)
- Evidence of aspirin-sensitive asthma.
- Pre-existing lung disease other than asthma.
- Clinically significant dermatologic, hematological, renal, endocrine, pulmonary (other than asthma), gastrointestinal, cardiovascular, hepatic, neurologic, ophthalmologic, musculoskeletal or immunologic disease (excepting allergic disease and asthma) that is uncontrolled despite treatment or is likely in the opinion of the Investigator to require a change in therapy during the study.
- Patients with any current or past history of cancer within 5 years prior to study start except for treated basal cell or squamous cell carcinomas of the skin, ductal carcinoma in situ of the breast or cervical carcinomas in situ.
- Any history of serious illness requiring hospitalization within 6 months prior to study start.
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 |
|---|---|---|
| ARRY-502, CRTh2 antagonist; oralmultiple dose, single schedule | Drug | ARRY-502 |
| Placebo; oralmatching placebo | Drug | Placebo |
Primary outcome
Assess the efficacy of the study drug (versus placebo) in terms of prebronchodilator forced expiratory volume in 1 second (FEV1).
Time frame: 6 weeks
4 secondary outcomes
Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests, vital signs and electrocardiograms.
Time frame: 6 weeks
Measure the exposure of study drug in terms of plasma concentrations.
Time frame: 6 weeks
Assess the effect of study drug on asthma control in terms of Asthma Control Questionnaire (ACQ) score, the number of symptom-free days and the number of weekly short-acting beta (ß) 2 agonist (SABA) metered dose inhaler (MDI) actuations.
Time frame: 6 weeks
Assess the effect of study drug on respiratory function in terms of FEV1, forced vital capacity (FVC), forced expiratory flow (FEF) and peak expiratory flow (PEF).
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2023.
- Individual participant dataSharing planned: Yes. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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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.
Pfizer CT.gov Call Center study director
Pfizer
43 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ARRY-502, CRTh2 antagonist; oral in people with Asthma, run by Pfizer at 43 sites in United States.
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 5 inclusion and 11 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 30 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 sites in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Assess the efficacy of the study drug (versus placebo) in terms of prebronchodilator forced expiratory volume in 1 second (FEV1). (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Oct 2023.