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

January 27, 2014 updated by: AstraZeneca

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

214

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1 Symbicort/inhaler
Symbicort BA MDI 2x160/4.5 μg twice daily
Drug: Symbicort
Breath actuated metered dose inhaler
Drug: Symbicort
Actuation counter pressured metered dose inhaler
Active Comparator: Symbicort/inhaler
Symbicort AC pDMI 2x160/4.5 μg twice daily
Drug: Symbicort
Breath actuated metered dose inhaler
Drug: Symbicort
Actuation counter pressured metered dose inhaler
Active Comparator: Budesonide/inhaler
Budesonide AC pMDI 2x160 μg twice daily
Drug: Budesonide
Actuation counter pressured metered dose inhaler

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
Time Frame: Pre AM dose in clinic visits at baseline, and week 3, 7, 12 and Trt Avg
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peak Expiratory Flow
Time Frame: Recorded morning upon rising and evening before sleep for 14 weeks
Recorded morning upon rising and evening before sleep for 14 weeks
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
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
Night-time Awakenings Due to Asthma Symptoms(% Awakening-free Nights)
Time Frame: Recorded 6:00 - 11:00 AM for 14 weeks
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
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: Goran Eckerwall, MD, AstraZeneca R&D, Mölndal

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

May 19, 2011

First Submitted That Met QC Criteria

May 24, 2011

First Posted (Estimate)

May 25, 2011

Study Record Updates

Last Update Posted (Estimate)

March 11, 2014

Last Update Submitted That Met QC Criteria

January 27, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D589OC00003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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