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
CHASE 3
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
1 other identifier
interventional
882
4 countries
70
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 asthma
Started Apr 2014
Typical duration for phase_3 asthma
70 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 18, 2014
CompletedFirst Posted
Study publicly available on registry
March 19, 2014
CompletedStudy Start
First participant enrolled
April 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2016
CompletedResults Posted
Study results publicly available
April 10, 2017
CompletedApril 10, 2017
February 1, 2017
2 years
March 18, 2014
October 11, 2016
February 24, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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).
Week 0 (baseline), Week 12
Secondary Outcomes (13)
Change From Baseline to Week 12 in 1h Post-dose PEF
Week 0 (baseline), Week 12
Change From Baseline to Week 12 in 1h Post-dose FEF25-75
Week 0 (baseline), Week 12
Change From Baseline to Week 12 in 1h Post-dose FVC
Week 0 (baseline), Week 12
Change From Baseline to Week 12 in Pre-dose FEV1
Week 0 (baseline), Week 12
Change From Baseline to Week 12 in Pre-dose PEF
Week 0 (baseline), Week 12
- +8 more secondary outcomes
Study Arms (3)
Symbicort pMDI 80/2.25 µg
ACTIVE COMPARATORBudesonide/formoterol pMDI 80/2.25 µg, 2 acuations twice daily
Symbicort pMDI 80/4.5µg
ACTIVE COMPARATORBudesonide/formoterol pMDI 80/4.5µg, 2 acuations twice daily
Budesonide pMDI
ACTIVE COMPARATORBudesonide pMDI 80µg, 2 acuations twice daily
Interventions
Budesonide/formoterol pMDI 80/2.25 µg, 2 acuations twice daily
Budesonide pMDI 80µg, 2 acuations twice daily
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (70)
Research Site
Hoover, Alabama, United States
Research Site
Montgomery, Alabama, United States
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Gilbert, Arizona, United States
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Little Rock, Arkansas, United States
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Huntington Beach, California, United States
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Long Beach, California, United States
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Mission Viejo, California, United States
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Newport Beach, California, United States
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Ontario, California, United States
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Stockton, California, United States
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Walnut Creek, California, United States
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Colorado Springs, Colorado, United States
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Denver, Colorado, United States
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Aventura, Florida, United States
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Coral Gables, Florida, United States
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Fort Walton Beach, Florida, United States
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Hialeah, Florida, United States
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Homestead, Florida, United States
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Jacksonville, Florida, United States
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Largo, Florida, United States
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Miami, Florida, United States
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Williston, Florida, United States
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Winter Park, Florida, United States
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Savannah, Georgia, United States
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Stockbridge, Georgia, United States
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Lenexa, Kansas, United States
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Waldorf, Maryland, United States
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Plymouth, Minnesota, United States
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Bellevue, Nebraska, United States
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Verona, New Jersey, United States
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Albuquerque, New Mexico, United States
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Rockville Centre, New York, United States
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Watertown, New York, United States
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Charlotte, North Carolina, United States
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Canton, Ohio, United States
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Cincinnati, Ohio, United States
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Toledo, Ohio, United States
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Edmond, Oklahoma, United States
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Oklahoma City, Oklahoma, United States
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Gresham, Oregon, United States
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Medford, Oregon, United States
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Portland, Oregon, United States
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Upland, Pennsylvania, United States
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North Charleston, South Carolina, United States
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Spartanburg, South Carolina, United States
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West Columbia, South Carolina, United States
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Allen, Texas, United States
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Baytown, Texas, United States
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El Paso, Texas, United States
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Fort Worth, Texas, United States
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Houston, Texas, United States
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Kerville, Texas, United States
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Richmond, Texas, United States
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San Antonio, Texas, United States
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Waco, Texas, United States
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Murray, Utah, United States
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Fairfax, Virginia, United States
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Tacoma, Washington, United States
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Washington, Washington, United States
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Cuautitlán Izcalli, Mexico
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México, Mexico
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Monterrey, Mexico
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David Chiriqui, Panama
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Panama City, Panama
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Banská Bystrica, Slovakia
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Bratislava, Slovakia
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Košice, Slovakia
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Lučenec, Slovakia
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Poprad, Slovakia
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Prešov, Slovakia
Related Publications (1)
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.
PMID: 28256307DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Clinical Lead Göran Eckerwall
- Organization
- AstraZeneca
Study Officials
- PRINCIPAL INVESTIGATOR
David S Pearlman, MD
Colorado Allergy Asthma Centers, PC, US
- STUDY DIRECTOR
Carin Jorup, MD
AstraZeneca Mölndal, Sweden
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 18, 2014
First Posted
March 19, 2014
Study Start
April 1, 2014
Primary Completion
April 1, 2016
Study Completion
April 1, 2016
Last Updated
April 10, 2017
Results First Posted
April 10, 2017
Record last verified: 2017-02