New Breath Actuated MDI Symbicort Compared to Symbicort pMDI and Budesonide pMDI for 12 Weeks Twice a Day
BAI
A 12-week, Double-blind, Randomized, Multi-centre, Parallel-group Study Evaluating the Efficacy Safety, and Patient Use (User Study) of Symbicort® (Budesonide/Formoterol) Breath Actuated Metered Dose Inhaler (BA MDI) 2x160/4.5 μg Twice Daily Compared With Symbicort (Budesonide/Formoterol) AC (Actuation Counter) pMDI® 2x160/4.5 μg Twice Daily and Budesonide AC pMDI 2x160 μg Twice Daily in Adult and Adolescent Asthmatics
1 other identifier
interventional
214
4 countries
41
Brief Summary
This is a comparison of the efficacy of the Symbicort breath actuated dose inhaler to the Symbicort pressured meter dose inhaler after 12 weeks of a twice a day dose.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 asthma
Started Nov 2011
Shorter than P25 for phase_3 asthma
41 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
May 19, 2011
CompletedFirst Posted
Study publicly available on registry
May 25, 2011
CompletedStudy Start
First participant enrolled
November 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedResults Posted
Study results publicly available
March 11, 2014
CompletedMarch 11, 2014
January 1, 2014
9 months
May 19, 2011
July 19, 2013
January 27, 2014
Conditions
Outcome Measures
Primary Outcomes (2)
Forced Expiratory Volume in 1 Second (FEV1) - Post Dose
Descriptive statistics for post-dose FEV1 (L) by visit; Baseline defined as the last pre-dose value prior to 1st dose of randomized therapy. Trt Avg = Mean of all available valid values after randomization.
60 minutes post-dose in clinic visits at baseline, and week 0, 3, 7, 12 and Trt Avg
Forced Expiratory Volume in 1 Second (FEV1) - Pre Dose
Descriptive statistics for predose FEV1(L) by visit; Baseline defined as the last pre-dose value prior to 1st dose of randomized therapy. Trt Avg = Mean of all available valid values after randomization.
Pre AM dose in clinic visits at baseline, and week 3, 7, 12 and Trt Avg
Secondary Outcomes (4)
Peak Expiratory Flow
Recorded morning upon rising and evening before sleep for 14 weeks
Asthma Symptoms Score (Total)
Recorded between 6:00 - 11:00 AM from previous 12 hours and 6:00 -11:00 PM from previous 12 hours for 14 weeks
Night-time Awakenings Due to Asthma Symptoms(% Awakening-free Nights)
Recorded 6:00 - 11:00 AM for 14 weeks
Use of Rescue Medication Day and Night (Total Daily Rescue Medication Use)
Recorded between 6:00 - 11:00 AM from previous 12 hours and 6:00 -11:00 PM from previous 12 hours for 14 weeks
Study Arms (3)
1 Symbicort/inhaler
ACTIVE COMPARATORSymbicort BA MDI 2x160/4.5 μg twice daily
Symbicort/inhaler
ACTIVE COMPARATORSymbicort AC pDMI 2x160/4.5 μg twice daily
Budesonide/inhaler
ACTIVE COMPARATORBudesonide AC pMDI 2x160 μg twice daily
Interventions
Eligibility Criteria
You may qualify if:
- Male or female 12 years and above
- Clinical diagnosis of asthma according to the American Thoracic Society definition at least 6 months
- Pre-bronchodilator FEV1 ≥ 45% and ≤ 85% of predicted normal
- Patients with reversible airway obstruction
- Documented daily use of inhaled corticosteroids for ≥ 3 months
You may not qualify if:
- History of life-threatening asthma, defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnea, respiratory arrest or hypoxic seizures during the 2 years prior to Visit 2
- Hospitalized during previous 6 months for asthma
- Required emergency treatment more than once during previous 6 months for an asthma-related condition
- Intake of oral, rectal or parenteral glucocorticosteroid within 30 days of enrolment
- Respiratory infection affecting the asthma within 30 days
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (41)
Research Site
Huntington Beach, California, United States
Research Site
Long Beach, California, United States
Research Site
Los Angeles, California, United States
Research Site
Orange, California, United States
Research Site
Rancho Mirage, California, United States
Research Site
Riverside, California, United States
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Sacramento, California, United States
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San Diego, California, United States
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San Jose, California, United States
Research Site
Tallahassee, Florida, United States
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Savannah, Georgia, United States
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River Forest, Illinois, United States
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Louisville, Kentucky, United States
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Metairie, Louisiana, United States
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Bangor, Maine, United States
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Wheaton, Maryland, United States
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North Dartmouth, Massachusetts, United States
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Columbia, Missouri, United States
Research Site
Rolla, Missouri, United States
Research Site
Skillman, New Jersey, United States
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North Syracuse, New York, United States
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Rochester, New York, United States
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Cincinnati, Ohio, United States
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Collegeville, Pennsylvania, United States
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Lincoln, Rhode Island, United States
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Charleston, South Carolina, United States
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Spartanburg, South Carolina, United States
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Dallas, Texas, United States
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Tacoma, Washington, United States
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Greenfield, Wisconsin, United States
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Madison, Wisconsin, United States
Research Site
Rousse, Bulgaria, Bulgaria
Research Site
Sevlievo, Bulgaria, Bulgaria
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Sofia, Bulgaria, Bulgaria
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Varna, Bulgaria, Bulgaria
Research Site
Balassagyarmat, Hungary, Hungary
Research Site
Budapest, Hungary, Hungary
Research Site
Salgótarján, Hungary, Hungary
Research Site
Százhalombatta, Hungary, Hungary
Research Site
Moscow, Russia, Russia
Research Site
Yekaterinburg, Russia, Russia
Related Publications (1)
Murphy KR, Dhand R, Trudo F, Uryniak T, Aggarwal A, Eckerwall G. Therapeutic equivalence of budesonide/formoterol delivered via breath-actuated inhaler vs pMDI. Respir Med. 2015 Feb;109(2):170-9. doi: 10.1016/j.rmed.2014.12.009. Epub 2015 Jan 3.
PMID: 25596138DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
No. of participants in the safety analysis set is (71 for all the group) as 1 patients from the Budesonide group has not taken any dose of the IP, so not included in the Safety population.
Results Point of Contact
- Title
- Goran Eckerwall, MD
- Organization
- Astrazeneca
Study Officials
- STUDY DIRECTOR
Goran Eckerwall, MD
AstraZeneca R&D, Mölndal
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 19, 2011
First Posted
May 25, 2011
Study Start
November 1, 2011
Primary Completion
August 1, 2012
Study Completion
August 1, 2012
Last Updated
March 11, 2014
Results First Posted
March 11, 2014
Record last verified: 2014-01