Trial record 1 of 1 for:    D589OC00003
Previous Study | Return to List | Next Study

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01360021
First received: May 19, 2011
Last updated: January 27, 2014
Last verified: January 2014
  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.


Condition Intervention Phase
Asthma
Drug: Symbicort
Drug: Budesonide
Phase 3

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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

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.


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.


Enrollment: 214
Study Start Date: November 2011
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Symbicort/inhaler
Symbicort BA MDI 2x160/4.5 μg twice daily
Drug: Symbicort
Breath actuated metered dose inhaler
Active Comparator: Symbicort/inhaler
Symbicort AC pDMI 2x160/4.5 μg twice daily
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

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01360021

  Show 41 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Goran Eckerwall, MD AstraZeneca R&D, Mölndal
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01360021     History of Changes
Other Study ID Numbers: D589OC00003
Study First Received: May 19, 2011
Results First Received: July 19, 2013
Last Updated: January 27, 2014
Health Authority: United States: Food and Drug Administration
Bulgaria: Executive Drug Agency
Hungary: National Institute of Pharmacy
Russia: Ministry of Health of the Russian Federation

Additional relevant MeSH terms:
Budesonide
Symbicort
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Autonomic Agents
Bronchodilator Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014