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

Asthma Clinical Trial

— BAI  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01360021
• Other study ID #: D589OC00003
• Status: Completed
• Phase: Phase 3
• First received: May 19, 2011
• Last updated: January 27, 2014
• Start date: November 2011
• Est. completion date: August 2012

Study information

• Verified date: January 2014
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationBulgaria: Executive Drug AgencyHungary: National Institute of PharmacyRussia: Ministry of Health of the Russian Federation
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 214
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Symbicort
Breath actuated metered dose inhaler
• Symbicort
Actuation counter pressured metered dose inhaler
• Budesonide
Actuation counter pressured metered dose inhaler

Locations

Country	Name	City	State
Bulgaria	Research Site	Ruse
Bulgaria	Research Site	Sevlievo
Bulgaria	Research Site	Sofia
Bulgaria	Research Site	Varna
Hungary	Research Site	Balassagyarmat
Hungary	Research Site	Budapest
Hungary	Research Site	Salgotarjan
Hungary	Research Site	Szazhalombatta
Russian Federation	Research Site	Ekaterinburg	Russia
Russian Federation	Research Site	Moscow	Russia
United States	Research Site	Bangor	Maine
United States	Research Site	Charleston	South Carolina
United States	Research Site	Cincinnati	Ohio
United States	Research Site	Collegeville	Pennsylvania
United States	Research Site	Columbia	Missouri
United States	Research Site	Dallas	Texas
United States	Research Site	Greenfield	Wisconsin
United States	Research Site	Huntington Beach	California
United States	Research Site	Lincoln	Rhode Island
United States	Research Site	Long Beach	California
United States	Research Site	Los Angeles	California
United States	Research Site	Louisville	Kentucky
United States	Research Site	Madison	Wisconsin
United States	Research Site	Metairie	Louisiana
United States	Research Site	North Dartmouth	Massachusetts
United States	Research Site	North Syracuse	New York
United States	Research Site	Orange	California
United States	Research Site	Rancho Mirage	California
United States	Research Site	River Forest	Illinois
United States	Research Site	Riverside	California
United States	Research Site	Rochester	New York
United States	Research Site	Rolla	Missouri
United States	Research Site	Sacramento	California
United States	Research Site	San Diego	California
United States	Research Site	San Jose	California
United States	Research Site	Savannah	Georgia
United States	Research Site	Skillman	New Jersey
United States	Research Site	Spartanburg	South Carolina
United States	Research Site	Tacoma	Washington
United States	Research Site	Tallahassee	Florida
United States	Research Site	Wheaton	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Bulgaria,  Hungary,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	Peak Expiratory Flow		Recorded morning upon rising and evening before sleep for 14 weeks	No
Secondary	Asthma Symptoms Score (Total)	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.	Recorded between 6:00 - 11:00 AM from previous 12 hours and 6:00 -11:00 PM from previous 12 hours for 14 weeks	No
Secondary	Night-time Awakenings Due to Asthma Symptoms(% Awakening-free Nights)	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.	Recorded 6:00 - 11:00 AM for 14 weeks	No
Secondary	Use of Rescue Medication Day and Night (Total Daily Rescue Medication Use)	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.	Recorded between 6:00 - 11:00 AM from previous 12 hours and 6:00 -11:00 PM from previous 12 hours for 14 weeks	No