Clinical trial NCT01360021: New Breath Actuated MDI Symbicort Compared to Symbicort pMDI and Budesonide pMDI for 12 Weeks Twice a Day
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2011-05-25
Enrollment: 214
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Forced Expiratory Volume in 1 Second (FEV1) - Post Dose
timeFrame: 60 minutes post-dose in clinic visits at baseline, and week 0, 3, 7, 12 and Trt Avg
measure: Forced Expiratory Volume in 1 Second (FEV1) - Pre Dose
timeFrame: Pre AM dose in clinic visits at baseline, and week 3, 7, 12 and Trt Avg
Secondary outcomes:
measure: Peak Expiratory Flow
timeFrame: Recorded morning upon rising and evening before sleep for 14 weeks
measure: Asthma Symptoms Score (Total)
timeFrame: Recorded between 6:00 - 11:00 AM from previous 12 hours and 6:00 -11:00 PM from previous 12 hours for 14 weeks
measure: Night-time Awakenings Due to Asthma Symptoms(% Awakening-free Nights)
timeFrame: Recorded 6:00 - 11:00 AM for 14 weeks
measure: Use of Rescue Medication Day and Night (Total Daily Rescue Medication Use)
timeFrame: Recorded between 6:00 - 11:00 AM from previous 12 hours and 6:00 -11:00 PM from previous 12 hours for 14 weeks
Other outcomes:
Locations:
city: Huntington Beach
country: United States
facility: Research Site
state: California
city: Long Beach
country: United States
facility: Research Site
state: California
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Orange
country: United States
facility: Research Site
state: California
city: Rancho Mirage
country: United States
facility: Research Site
state: California
city: Riverside
country: United States
facility: Research Site
state: California
city: Sacramento
country: United States
facility: Research Site
state: California
city: San Diego
country: United States
facility: Research Site
state: California
city: San Jose
country: United States
facility: Research Site
state: California
city: Tallahassee
country: United States
facility: Research Site
state: Florida
city: Savannah
country: United States
facility: Research Site
state: Georgia
city: River Forest
country: United States
facility: Research Site
state: Illinois
city: Louisville
country: United States
facility: Research Site
state: Kentucky
city: Metairie
country: United States
facility: Research Site
state: Louisiana
city: Bangor
country: United States
facility: Research Site
state: Maine
city: Wheaton
country: United States
facility: Research Site
state: Maryland
city: North Dartmouth
country: United States
facility: Research Site
state: Massachusetts
city: Columbia
country: United States
facility: Research Site
state: Missouri
city: Rolla
country: United States
facility: Research Site
state: Missouri
city: Skillman
country: United States
facility: Research Site
state: New Jersey
city: North Syracuse
country: United States
facility: Research Site
state: New York
city: Rochester
country: United States
facility: Research Site
state: New York
city: Cincinnati
country: United States
facility: Research Site
state: Ohio
city: Collegeville
country: United States
facility: Research Site
state: Pennsylvania
city: Lincoln
country: United States
facility: Research Site
state: Rhode Island
city: Charleston
country: United States
facility: Research Site
state: South Carolina
city: Spartanburg
country: United States
facility: Research Site
state: South Carolina
city: Dallas
country: United States
facility: Research Site
state: Texas
city: Tacoma
country: United States
facility: Research Site
state: Washington
city: Greenfield
country: United States
facility: Research Site
state: Wisconsin
city: Madison
country: United States
facility: Research Site
state: Wisconsin
city: Ruse
country: Bulgaria
facility: Research Site
city: Sevlievo
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Varna
country: Bulgaria
facility: Research Site
city: Balassagyarmat
country: Hungary
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Salgotarjan
country: Hungary
facility: Research Site
city: Szazhalombatta
country: Hungary
facility: Research Site
city: Ekaterinburg
country: Russian Federation
facility: Research Site
state: Russia
city: Moscow
country: Russian Federation
facility: Research Site
state: Russia
Study officials:
affiliation: AstraZeneca R&D, Mölndal
name: Goran Eckerwall, MD
role: STUDY_DIRECTOR
References:
citation: 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.