A 6-week Study in Asthmatic Children Aged 6 to <12 Yrs Comparing Budesonide pMDI 160ug Twice Daily With Placebo
CHASE 1
Phase 2, Double-blind, Randomized, Parallel-group, Placebo-controlled, Multicenter Study, Comparing Budesonide pMDI 160 ug Bid With Placebo: a 6-week Efficacy and Safety Study in Children Aged 6 to <12 Years With Asthma
1 other identifier
interventional
304
7 countries
87
Brief Summary
This purpose of the study is to investigate if budesonide pMDI 160 �g twice a day during 6 weeks is effective and safe in treating asthmatic children aged 6 to \<12 years
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 asthma
Started Jul 2010
Longer than P75 for phase_2 asthma
87 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
June 1, 2010
CompletedFirst Posted
Study publicly available on registry
June 3, 2010
CompletedStudy Start
First participant enrolled
July 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedResults Posted
Study results publicly available
July 21, 2014
CompletedAugust 1, 2014
July 1, 2014
2.8 years
June 1, 2010
March 25, 2014
July 30, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Morning Peak Expiratory Flow (PEF) From Baseline to the Treatment Period Average
The peak expiratory flow rate is the maximal rate that a person can exhale during a short maximal expiratory effort after a full inspiration. Baseline was calculated using the mean of the data recorded during the last 7 days of the run-in period, and the treatment period average was calculated as the mean of all available data recorded during the entire treatment period.
Baseline to 6 weeks
Secondary Outcomes (10)
Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline to Treatment Period Average
Baseline to 6 weeks
Change in Evening PEF From Baseline to the Treatment Period Average
Baseline to 6 weeks
Change in Forced Vital Capacity (FVC) From Baseline to Treatment Period Average
Baseline to 6 weeks
Change in Forced Mid-expiratory Flow Between 25% and 75% of the FVC (FEF25-75) From Baseline to Treatment Period Average
Baseline to 6 weeks
Change in Total Daily and Daytime Asthma Symptom Scores From Baseline to Treatment Period Average
Baseline to 6 weeks
- +5 more secondary outcomes
Study Arms (2)
1
EXPERIMENTALBudesonide pMDI 160 ug bid (80 ug x 2 inhalations bid)
2
PLACEBO COMPARATORPlacebo pMDI 2 inhalations bid
Interventions
Eligibility Criteria
You may qualify if:
- Has a documented clinical diagnosis of asthma for at least 6 months prior to Visit 2 that has required daily inhaled corticosteroid in the low dose range OR LTRA as monotherapy for at least 30 days prior to Visit 2.
- Has a morning clinic pre-bronchodilator FEV1 measured at least 6 hours after the last dose of inhaled short acting beta agonist of greater than or equal to 70% and less than or equal to 95% of predicted normal
- Demonstrated reversibility of FEV1 of ≥12% from pre short acting beta agonist level within 15 to 30 minutes after administration of a standard dose of short acting beta agonist OR has a documented reversibility of ≥ 12 % within 12 months prior to Visit 2.
You may not qualify if:
- Has been hospitalized at least once or required emergency treatment (was seen in the emergency room or had an urgent care visit) more than once for an asthma-related condition during the 6 months prior to Visit 2
- Has required treatment with systemic corticosteroids (eg, oral, parenteral, or rectal) for any reason within the 12 weeks prior to Visit 2
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (87)
Research Site
Scottsdale, Arizona, United States
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Fresno, California, United States
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Granada Hills, California, United States
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Huntington Beach, California, United States
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Mission Viejo, California, United States
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Orange, California, United States
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Palmdal, California, United States
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Rolling Hills Estate, California, United States
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San Diego, California, United States
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Stockton, California, United States
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Centennial, Colorado, United States
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Colorado Springs, Colorado, United States
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Denver, Colorado, United States
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Coral Gables, Florida, United States
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Orange City, Florida, United States
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Sarasota, Florida, United States
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Albany, Georgia, United States
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Gainesville, Georgia, United States
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Normal, Illinois, United States
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Overland Park, Kansas, United States
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Bethesda, Maryland, United States
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North Dartmouth, Massachusetts, United States
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Ypsilanti, Michigan, United States
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Plymouth, Minnesota, United States
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Columbia, Missouri, United States
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St Louis, Missouri, United States
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Bozeman, Montana, United States
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Bellevue, Nebraska, United States
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Omaha, Nebraska, United States
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Ocean City, New Jersey, United States
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Skillman, New Jersey, United States
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Teaneck, New Jersey, United States
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Rockville Centre, New York, United States
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High Point, North Carolina, United States
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Canton, Ohio, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Sylvania, Ohio, United States
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Toledo, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Gresham, Oregon, United States
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Lake Oswego, Oregon, United States
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Medford, Oregon, United States
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Portland, Oregon, United States
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Altoona, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Upland, Pennsylvania, United States
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Charleston, South Carolina, United States
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Dallas, 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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Georgetown, Texas, United States
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San Antonio, Texas, United States
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Waco, Texas, United States
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Richmond, Virginia, United States
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Greenfield, Wisconsin, United States
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West Allis, Wisconsin, United States
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Plovdiv, Bulgaria
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Rousse, Bulgaria
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Sofia, Bulgaria
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Budapest, Hungary
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Debrecen, Hungary
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Győr, Hungary
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Kiskunhalas, Hungary
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Marcali, Hungary
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Miskolc, Hungary
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Nyíregyháza, Hungary
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Sopron, Hungary
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Szeged, Hungary
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Szigetvár, Hungary
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Törökbálint, Hungary
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Zalaegerszeg, Hungary
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Ogre, Latvia
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Rēzekne, Latvia
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Riga, Latvia
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Bialystok, Poland
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Częstochowa, Poland
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Karpacz, Poland
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Lodz, Poland
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Pabianice, Poland
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Bratislava, Slovakia
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Lučenec, Slovakia
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Krugersdorp, Gauteng, South Africa
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Durban, KwaZulu-Natal, South Africa
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Pietermariztburg, KwaZulu-Natal, South Africa
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Claremont, W Cape, South Africa
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Panorama, W Cape, South Africa
Related Publications (1)
Meltzer EO, Pearlman DS, Eckerwall G, Uryniak T, DePietro M, Lampl K. Efficacy and safety of budesonide administered by pressurized metered-dose inhaler in children with asthma. Ann Allergy Asthma Immunol. 2015 Dec;115(6):516-22. doi: 10.1016/j.anai.2015.09.007. Epub 2015 Oct 13.
PMID: 26460293DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Geoff Gilmartin
- Organization
- AstraZeneca
Study Officials
- STUDY DIRECTOR
Göran Eckerwall, MD
AZ R&D Mölndal
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- 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
June 1, 2010
First Posted
June 3, 2010
Study Start
July 1, 2010
Primary Completion
April 1, 2013
Study Completion
April 1, 2013
Last Updated
August 1, 2014
Results First Posted
July 21, 2014
Record last verified: 2014-07