AsthmaPhase 3CHASE 3NCT02091986
A 12-Week Study in Asthmatic Children Ages 6 to <12 Years, Investigating the Efficacy and Safety of Symbicort pMDI 80/2.25 μg and Symbicort pMDI 80/4.5 μg, Compared With Budesonide pMDI 80 μg
A Phase 3 study testing Symbicort pMDI and Budesonide pMDI in people with Asthma, run by AstraZeneca at 70 sites in 4 countries.
Trial summary
The purpose is to investigate the Efficacy and Safety of Symbicort pMDI 80/2.25 μg and Symbicort pMDI 80/4.5 μg, Compared with Budesonide pMDI 80 μg, 2 Actuations Twice Daily, in Children Ages 6 to <12 Years with Asthma during 12 weeks. Read more about this study
- Who is it for?
- Ages 6 to 11 years
- Conditions the study is for
- Asthma
- What is being tested?
- Symbicort pMDI and Budesonide pMDI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 882 participants
- Where
- 70 sitesin 4 countries
- Study dates
- Apr 2014to Apr 2016
- Phase
- Phase 3
- 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 6 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Has a documented clinical diagnosis of asthma defined by the ATS for at least 6 months prior to Visit 2
- Have a morning pre-bronchodilator clinic FEV1 measured at least 6 hours after the last dose of inhaled SABA and at least 48 hours after last dose of inhaled LABA of 60% to 100% of predicted normal
- Demonstrated reversibility of clinic FEV1 of ≥12% from pre -albuterol/salbutamol level within 15 to 30 minutes after administration of a standard dose of albuterol/salbutamol.
Who cannot join
- Have been hospitalized at least once or required emergency treatment more than once for an asthma-related condition during the 6 months prior to Visit 1
- Have required treatment with systemic corticosteroids (eg, oral, parenteral, or rectal) for any reason within the 6 weeks prior to Visit 1
Trial locations and contacts
70 sites in 4 countries.
70 sites in 4 countries
United States59 sites
Research Site
Albuquerque, New Mexico
Research Site
Allen, Texas
Research Site
Aventura, Florida
Research Site
Baytown, Texas
Research Site
Bellevue, Nebraska
Research Site
Canton, Ohio
Research Site
Charlotte, North Carolina
Research Site
Cincinnati, Ohio
Research Site
Colorado Springs, Colorado
Research Site
Coral Gables, Florida
Research Site
Denver, Colorado
Research Site
Edmond, Oklahoma
Research Site
El Paso, Texas
Research Site
Fairfax, Virginia
Research Site
Fort Walton Beach, Florida
Research Site
Fort Worth, Texas
Research Site
Gilbert, Arizona
Research Site
Gresham, Oregon
Research Site
Hialeah, Florida
Research Site
Homestead, Florida
Research Site
Hoover, Alabama
Research Site
Houston, Texas
Research Site
Huntington Beach, California
Research Site
Jacksonville, Florida
Research Site
Kerville, Texas
Research Site
Largo, Florida
Research Site
Lenexa, Kansas
Research Site
Little Rock, Arkansas
Research Site
Long Beach, California
Research Site
Medford, Oregon
Research Site
Miami, Florida
Research Site
Mission Viejo, California
Research Site
Montgomery, Alabama
Research Site
Murray, Utah
Research Site
Newport Beach, California
Research Site
North Charleston, South Carolina
Research Site
Oklahoma City, Oklahoma
Research Site
Ontario, California
Research Site
Plymouth, Minnesota
Research Site
Portland, Oregon
Research Site
Richmond, Texas
Research Site
Rockville Centre, New York
Research Site
San Antonio, Texas
Research Site
Savannah, Georgia
Research Site
Spartanburg, South Carolina
Research Site
Stockbridge, Georgia
Research Site
Stockton, California
Research Site
Tacoma, Washington
Research Site
Toledo, Ohio
Research Site
Upland, Pennsylvania
Research Site
Verona, New Jersey
Research Site
Waco, Texas
Research Site
Waldorf, Maryland
Research Site
Walnut Creek, California
Research Site
Washington, Washington
Research Site
Watertown, New York
Research Site
West Columbia, South Carolina
Research Site
Williston, Florida
Research Site
Winter Park, Florida
Slovakia6 sites
Research Site
Banská Bystrica
Research Site
Bratislava
Research Site
Košice
Research Site
Lučenec
Research Site
Poprad
Research Site
Prešov
Mexico3 sites
Research Site
Cuautitlán Izcalli
Research Site
México
Research Site
Monterrey
About this study
Official title: A Phase 3, 12-Week, Double-Blind, Randomized, Parallel-Group, Multicenter Study Investigating the Efficacy and Safety of Symbicort pMDI 80/2.25 μg, 2 Actuations Twice Daily, and Symbicort pMDI 80/4.5 μg, 2 Actuations Twice Daily, Compared With Budesonide pMDI 80 μg, 2 Actuations Twice Daily, in Children Ages 6 to <12 Years With Asthma
The purpose is to investigate the Efficacy and Safety of Symbicort pMDI 80/2.25 μg and Symbicort pMDI 80/4.5 μg, Compared with Budesonide pMDI 80 μg, 2 Actuations Twice Daily, in Children Ages 6 to <12 Years with Asthma during 12 weeks.
Read the detailed description
A Phase 3, 12-Week, Double-Blind, Randomized, Parallel-Group, Multicenter Study Investigating the Efficacy and Safety of Symbicort pMDI 80/2.25 μg, 2 Actuations Twice Daily, and Symbicort pMDI 80/4.5 μg, 2 Actuations Twice Daily, Compared with Budesonide pMDI 80 μg, 2 Actuations Twice Daily, in Children Ages 6 to <12 Years with Asthma
- Conditions
- Asthma
- Being tested
- Symbicort pMDI, Budesonide pMDI
- Keywords
- asthma, children, budesonide pMDI
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Symbicort pMDIDrug
Budesonide/formoterol pMDI 80/2.25 µg, 2 acuations twice daily
Symbicort pMDIDrug
Budesonide/formoterol pMDI 80/4.5µg, 2 acuations twice daily
Budesonide pMDIOther
Also called Active comparator
Budesonide pMDI 80µg, 2 acuations twice daily
| Study group | Role | What they receive |
|---|---|---|
| Symbicort pMDI 80/2.25 µg | Active comparator | Budesonide/formoterol pMDI 80/2.25 µg, 2 acuations twice daily Receives: Drug: Symbicort pMDI |
| Symbicort pMDI 80/4.5µg | Active comparator | Budesonide/formoterol pMDI 80/4.5µg, 2 acuations twice daily Receives: Drug: Symbicort pMDI |
| Budesonide pMDI | Active comparator | Budesonide pMDI 80µg, 2 acuations twice daily Receives: Other: Budesonide pMDI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline to Week 12 in 1h Post-dose FEV1
1h post-dose FEV1 is defined as the 1-hour post-dose measurement taken at Week 12 minus the pre dose measurement taken at randomization for patients who remain in the study (irrespective of whether IP has been discontinued).
Measured: Week 0 (baseline), Week 12
Secondary outcomes (13)
Change From Baseline to Week 12 in 1h Post-dose PEF
1h post-dose PEF is defined as the 1-hour post-dose measurement taken at Week 12 minus the pre dose measurement taken at randomization for patients who remain in the study (irrespective of whether IP has been discontinued).
Measured: Week 0 (baseline), Week 12
Change From Baseline to Week 12 in 1h Post-dose FEF25-75
1h post-dose FEF25-75 is defined as the 1-hour post-dose measurement taken at Week 12 minus the pre dose measurement taken at randomization for patients who remain in the study (irrespective of whether IP has been discontinued).
Measured: Week 0 (baseline), Week 12
Change From Baseline to Week 12 in 1h Post-dose FVC
1h post-dose FVC is defined as the 1-hour post-dose measurement taken at Week 12 minus the pre dose measurement taken at randomization for patients who remain in the study (irrespective of whether IP has been discontinued).
Measured: Week 0 (baseline), Week 12
Change From Baseline to Week 12 in Pre-dose FEV1
Pre-dose FEV1 is defined as the pre-dose measurement taken at Week 12 minus the pre dose measurement taken at randomization for patients who remain in the study (irrespective of whether IP has been discontinued).
Measured: Week 0 (baseline), Week 12
Change From Baseline to Week 12 in Pre-dose PEF
Pre-dose PEF is defined as the pre-dose measurement taken at Week 12 minus the pre dose measurement taken at randomization for patients who remain in the study (irrespective of whether IP has been discontinued).
Measured: Week 0 (baseline), Week 12
Change From Baseline to Week 12 in Pre-dose FEF25-75
Pre-dose FEF25-75 is defined as the pre-dose measurement taken at Week 12 minus the pre dose measurement taken at randomization for patients who remain in the study (irrespective of whether IP has been discontinued).
Measured: Week 0 (baseline), Week 12
Change From Baseline to Week 12 in Pre-dose FVC
Pre-dose FVC is defined as the pre-dose measurement taken at Week 12 minus the pre dose measurement taken at randomization for patients who remain in the study (irrespective of whether IP has been discontinued).
Measured: Week 0 (baseline), Week 12
Change From Baseline to Week 12 in 15 Min Post-dose FEV1
15 min Post-dose FEV1 is defined as the 15 min post-dose measurement taken at Week 12 minus the pre dose measurement taken at randomization for patients who remain in the study (irrespective of whether IP has been discontinued).
Measured: Week 0 (baseline), Week 12
Change From Baseline to End of Study Average in Total Asthma Symptoms
End of study average is defined as the average of available records from 7 days before up to and including the day prior to withdrawal from study or Week 12, minus the baseline measurement at randomization, for patients who remain in the study (irrespective of whether IP has been discontinued).
Patient to record his/her asthma symptom score twice daily. The following rating scales are to be used: 0 = None; no symptoms of asthma
- = Mild symptoms; awareness of asthma symptoms and/or signs that are easily tolerated
- = Moderate symptoms, asthma symptoms with some discomfort, causing some interference with daily activities or sleep
- = Severe symptoms; incapacitating asthma symptoms and/or signs, with inability to perform daily activities or to sleep
Total asthma symptom score is derived as the sum of the daytime score plus the score from the previous nighttime, ie possible range (0 to 6).
Measured: Week 0 (baseline), Week 12
Change From Baseline to End of Study Average in % of Night Time Awakenings Due to Asthma Symptoms
End of study average is defined as the percentage of nighttime awakenings due to asthma symptoms from 6 days before up to and additionally including the morning of withdrawal from study or Week 12, minus the baseline measurement at randomization, for patients who remain in the study (irrespective of whether IP has been discontinued).
Measured: Week 0 (baseline), Week 12
Change From Baseline to End of Study Average in Total Daily Reliever Medication
End of study average is defined as the average of available records from 7 days before up to and including the day prior to withdrawal from study or Week 12, minus the baseline measurement at randomization, for patients who remain in the study (irrespective of whether IP has been discontinued).
Measured: Week 0 (baseline), Week 12
Change From Baseline to Study Period Average in Overall PAQLQ Score
Study period average is defined as the average of the post-baseline values during the study taken after first dose of investigational product up to and including withdrawal from study or Week 12, minus the baseline assessment at randomization, for patients who remain in the study (irrespective of whether IP has been discontinued).
The PAQLQ(S) is a 23-item patient-reported questionnaire, each one reported on a 7-point scale (e.g. 1 = extremely bothered/all of the time; 7 = not bothered/none of the time). The PAQLQ(S) generates an overall score, as well as 3 domain scores: activity limitations (5 items), symptoms (10 items) and emotional function (8 items). The overall score will be calculated as the mean of the responses to each of the 23 questions (ie the range of 1-7, where higher scores indicate better quality of life). If any of the domain scores are missing, no total score will be calculated.
Measured: Week 0 (baseline), week 4, week 8, week 12
Number of Patients With an Asthma Exacerbation During Study
Number of patients that experienced an asthma exacerbation that required either emergency room treatment, hospitalization, systemic steroids, or an increase in, or additional asthma maintenance medication, during the study.
Measured: Week 0 (baseline) up to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2014 (estimated)
- Study startApr 2014
- Primary completionApr 2016
- Study completionApr 2016
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 882 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David S Pearlman, MD, Principal investigator, Colorado Allergy Asthma Centers, PC, USCarin Jorup, MD, Study director, AstraZeneca Mölndal, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02091986
- Sponsor's protocol ID
- D589GC00003
- Acronym
- CHASE 3
- Status last verified
- Feb 2017
- First submitted
- 18 Mar 2014
- Last updated
- 10 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Pearlman DS, Eckerwall G, McLaren J, Lamarca R, Puu M, Gilbert I, Jorup C, Sandin K, Lanz MJ. Efficacy and safety of budesonide/formoterol pMDI vs budesonide pMDI in asthmatic children (6-<12 years). Ann Allergy Asthma Immunol. 2017 Apr;118(4):489-499.e1. doi: 10.1016/j.anai.2017.01.020. Epub 2017 Mar 1.
PubMed 28256307
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, 12-Week, Double-Blind, Randomized, Parallel-Group, Multicenter Study Investigating the Efficacy and Safety of Symbicort pMDI 80/2.25 μg, 2 Actuations Twice Daily, and Symbicort pMDI 80/4.5 μg, 2 Actuations Twice Daily, Compared With Budesonide pMDI 80 μg, 2 Actuations Twice Daily, in Children Ages 6 to <12 Years With Asthma
- ClinicalTrials.gov ID
- NCT02091986
- Acronym / sponsor ID
- CHASE 3 / D589GC00003
- Conditions
- Asthma
- Keywords
- asthma, children, budesonide pMDI
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 882 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Apr 2014
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 19 Mar 2014 (estimated)
- Results
- Posted 10 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose is to investigate the Efficacy and Safety of Symbicort pMDI 80/2.25 μg and Symbicort pMDI 80/4.5 μg, Compared with Budesonide pMDI 80 μg, 2 Actuations Twice Daily, in Children Ages 6 to <12 Years with Asthma during 12 weeks.
Detailed description
A Phase 3, 12-Week, Double-Blind, Randomized, Parallel-Group, Multicenter Study Investigating the Efficacy and Safety of Symbicort pMDI 80/2.25 μg, 2 Actuations Twice Daily, and Symbicort pMDI 80/4.5 μg, 2 Actuations Twice Daily, Compared with Budesonide pMDI 80 μg, 2 Actuations Twice Daily, in Children Ages 6 to <12 Years with Asthma
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 |
|---|---|---|
| Symbicort pMDI 80/2.25 µg | Active comparator | Drug: Symbicort pMDIBudesonide/formoterol pMDI 80/2.25 µg, 2 acuations twice daily |
| Symbicort pMDI 80/4.5µg | Active comparator | Drug: Symbicort pMDIBudesonide/formoterol pMDI 80/4.5µg, 2 acuations twice daily |
| Budesonide pMDI | Active comparator | Other: Budesonide pMDIBudesonide pMDI 80µg, 2 acuations twice daily |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Has a documented clinical diagnosis of asthma defined by the ATS for at least 6 months prior to Visit 2
- Have a morning pre-bronchodilator clinic FEV1 measured at least 6 hours after the last dose of inhaled SABA and at least 48 hours after last dose of inhaled LABA of 60% to 100% of predicted normal
- Demonstrated reversibility of clinic FEV1 of ≥12% from pre -albuterol/salbutamol level within 15 to 30 minutes after administration of a standard dose of albuterol/salbutamol.
Key exclusion criteria (2 listed)
- Have been hospitalized at least once or required emergency treatment more than once for an asthma-related condition during the 6 months prior to Visit 1
- Have required treatment with systemic corticosteroids (eg, oral, parenteral, or rectal) for any reason within the 6 weeks prior to Visit 1
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 |
|---|---|---|
| Symbicort pMDIBudesonide/formoterol pMDI 80/2.25 µg, 2 acuations twice daily | Drug | Symbicort pMDI 80/2.25 µg |
| Symbicort pMDIBudesonide/formoterol pMDI 80/4.5µg, 2 acuations twice daily | Drug | Symbicort pMDI 80/4.5µg |
| Budesonide pMDIAlso: Active comparatorBudesonide pMDI 80µg, 2 acuations twice daily | Other | Budesonide pMDI |
Primary outcome
Change From Baseline to Week 12 in 1h Post-dose FEV1
Time frame: Week 0 (baseline), Week 12
1h post-dose FEV1 is defined as the 1-hour post-dose measurement taken at Week 12 minus the pre dose measurement taken at randomization for patients who remain in the study (irrespective of whether IP has been discontinued).
13 secondary outcomes
Change From Baseline to Week 12 in 1h Post-dose PEF
Time frame: Week 0 (baseline), Week 12
Change From Baseline to Week 12 in 1h Post-dose FEF25-75
Time frame: Week 0 (baseline), Week 12
Change From Baseline to Week 12 in 1h Post-dose FVC
Time frame: Week 0 (baseline), Week 12
Change From Baseline to Week 12 in Pre-dose FEV1
Time frame: Week 0 (baseline), Week 12
Change From Baseline to Week 12 in Pre-dose PEF
Time frame: Week 0 (baseline), Week 12
Change From Baseline to Week 12 in Pre-dose FEF25-75
Time frame: Week 0 (baseline), Week 12
Change From Baseline to Week 12 in Pre-dose FVC
Time frame: Week 0 (baseline), Week 12
Change From Baseline to Week 12 in 15 Min Post-dose FEV1
Time frame: Week 0 (baseline), Week 12
Change From Baseline to End of Study Average in Total Asthma Symptoms
Time frame: Week 0 (baseline), Week 12
Change From Baseline to End of Study Average in % of Night Time Awakenings Due to Asthma Symptoms
Time frame: Week 0 (baseline), Week 12
Change From Baseline to End of Study Average in Total Daily Reliever Medication
Time frame: Week 0 (baseline), Week 12
Change From Baseline to Study Period Average in Overall PAQLQ Score
Time frame: Week 0 (baseline), week 4, week 8, week 12
Number of Patients With an Asthma Exacerbation During Study
Time frame: Week 0 (baseline) up to Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28256307Pearlman DS, Eckerwall G, McLaren J, Lamarca R, Puu M, Gilbert I, Jorup C, Sandin K, Lanz MJ. Efficacy and safety of budesonide/formoterol pMDI vs budesonide pMDI in asthmatic children (6-<12 years). Ann Allergy Asthma Immunol. 2017 Apr;118(4):489-499.e1. doi: 10.1016/j.anai.2017.01.020. Epub 2017 Mar 1.
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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.
David S Pearlman, MD principal investigator
Colorado Allergy Asthma Centers, PC, US
Carin Jorup, MD study director
AstraZeneca Mölndal, Sweden
70 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Symbicort pMDI and Budesonide pMDI in people with Asthma, run by AstraZeneca at 70 sites in 4 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 3 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 10 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 70 sites in United States, Slovakia, Mexico, Panama. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 10 Apr 2017). 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 From Baseline to Week 12 in 1h Post-dose FEV1 (time frame: Week 0 (baseline), Week 12). 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 NCT02091986, which also lists 1 linked publication.
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 10 Apr 2017.