New Breath Actuated MDI Symbicort Compared to Symbicort pMDI and Budesonide pMDI for 12 Weeks Twice a Day

Overview[ - collapse ][ - ]

Purpose 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.
ConditionAsthma
InterventionDrug: Symbicort
Drug: Symbicort
Drug: Budesonide
PhasePhase 3
SponsorAstraZeneca
Responsible PartyAstraZeneca
ClinicalTrials.gov IdentifierNCT01360021
First ReceivedMay 19, 2011
Last UpdatedJanuary 27, 2014
Last verifiedJanuary 2014

Tracking Information[ + expand ][ + ]

First Received DateMay 19, 2011
Last Updated DateJanuary 27, 2014
Start DateNovember 2011
Estimated Primary Completion DateAugust 2012
Current Primary Outcome Measures
  • Forced Expiratory Volume in 1 Second (FEV1) - Post Dose [Time Frame: 60 minutes post-dose in clinic visits at baseline, and week 0, 3, 7, 12 and Trt Avg] [Designated as safety issue: No]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.
  • Forced Expiratory Volume in 1 Second (FEV1) - Pre Dose [Time Frame: Pre AM dose in clinic visits at baseline, and week 3, 7, 12 and Trt Avg] [Designated as safety issue: No]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.
Current Secondary Outcome Measures
  • Peak Expiratory Flow [Time Frame: Recorded morning upon rising and evening before sleep for 14 weeks] [Designated as safety issue: No]
  • Asthma Symptoms Score (Total) [Time Frame: Recorded between 6:00 - 11:00 AM from previous 12 hours and 6:00 -11:00 PM from previous 12 hours for 14 weeks] [Designated as safety issue: No]The total score is calculated as sum of the morning and evening scores of each day and the treatment period mean score is defined as the mean of all total score recorded during the 12-week treatment period. Trt Avg=Mean total score of double-blind period values.(day/night score ranges from 0 to 3; 0=no asthma symptoms; 3= unable to do normal activities (or to sleep) due to asthma). Higher score represents worse outcome.
  • Night-time Awakenings Due to Asthma Symptoms(% Awakening-free Nights) [Time Frame: Recorded 6:00 - 11:00 AM for 14 weeks] [Designated as safety issue: No]The percentage of days with no awakenings due to asthma. Baseline= Mean % awakening-free nights during run-in period ; Trt Avg=Mean % awakening-free nights during double-blind period.
  • Use of Rescue Medication Day and Night (Total Daily Rescue Medication Use) [Time Frame: Recorded between 6:00 - 11:00 AM from previous 12 hours and 6:00 -11:00 PM from previous 12 hours for 14 weeks] [Designated as safety issue: No]Total daily rescue medication use is calculated as the sum of morning and evening use each day and averaged over the 12 weeks treatment periods to calculate the treatment period mean. Baseline= Mean rescue medication used during run-in period ; Trt Avg=Mean rescue medication used during double-blind period.

Descriptive Information[ + expand ][ + ]

Brief TitleNew Breath Actuated MDI Symbicort Compared to Symbicort pMDI and Budesonide pMDI for 12 Weeks Twice a Day
Official TitleA 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
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.
Detailed DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 3
Study DesignAllocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
ConditionAsthma
InterventionDrug: Symbicort
Breath actuated metered dose inhaler
Drug: Symbicort
Actuation counter pressured metered dose inhaler
Drug: Budesonide
Actuation counter pressured metered dose inhaler
Study Arm (s)
  • Active Comparator: 1 Symbicort/inhaler
    Symbicort BA MDI 2x160/4.5 μg twice daily
  • Active Comparator: Symbicort/inhaler
    Symbicort AC pDMI 2x160/4.5 μg twice daily
  • Active Comparator: Budesonide/inhaler
    Budesonide AC pMDI 2x160 μg twice daily

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment214
Estimated Completion DateAugust 2012
Estimated Primary Completion DateAugust 2012
Eligibility Criteria
Inclusion Criteria:

- 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

Exclusion Criteria:

- 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
GenderBoth
Ages12 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesUnited States, Bulgaria, Hungary, Russian Federation

Administrative Information[ + expand ][ + ]

NCT Number NCT01360021
Other Study ID NumbersD589OC00003
Has Data Monitoring CommitteeNot Provided
Information Provided ByAstraZeneca
Study SponsorAstraZeneca
CollaboratorsNot Provided
Investigators Study Director: Goran Eckerwall, MD AstraZeneca R&D, Mölndal
Verification DateJanuary 2014

Locations[ + expand ][ + ]

Research Site
Huntington Beach, California, United States
Research Site
Long Beach, California, United States
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Los Angeles, California, United States
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Orange, California, United States
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Rancho Mirage, California, United States
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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
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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
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Rolla, Missouri, United States
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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
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Ruse, Bulgaria
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Sevlievo, Bulgaria
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Sofia, Bulgaria
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Varna, Bulgaria
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Balassagyarmat, Hungary
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Budapest, Hungary
Research Site
Salgotarjan, Hungary
Research Site
Szazhalombatta, Hungary
Research Site
Ekaterinburg, Russia, Russian Federation
Research Site
Moscow, Russia, Russian Federation