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 3, 2013

Last verified: January 2013

History of Changes

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:

MedlinePlus related topics: Asthma

Drug Information available for: Budesonide

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Forced expiratory volume in 1 second (FEV1) [ Time Frame: Pre AM dose in clinic visits at baseline, and week 3, 7 and 12 ] [ Designated as safety issue: No ]
Forced expiratory volume in 1 second (FEV1) [ Time Frame: 60 minutes post-dose in clinic visits at baseline, and week 3, 7 and 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Peek expiratory flow [ Time Frame: Recorded morning upon rising and evening before sleep for 14 weeks ] [ Designated as safety issue: No ]
Asthma symptoms and use of rescue medications [ 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 ]
Night-time awakenings due to asthma symptoms [ Time Frame: Recorded 6:00 - 11:00 AM for 14 weeks ] [ Designated as safety issue: No ]

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

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
Last Updated:	January 3, 2013
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:

Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Budesonide
Symbicort
Bronchodilator Agents

Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on June 18, 2013

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