A Comparison of SYMBICORT® pMDI With Formoterol Turbuhaler® in Subjects With COPD - Full Text View

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00419744

Purpose

The purpose of this study is to determine if SYMBICORT® delivered via a pressurized metered-dose inhaler, referred to as a pMDI, is effective in preventing COPD exacerbations.

Condition	Intervention	Phase
Chronic Obstructive Pulmonary Disease	Drug: Budesonide/formoterol (SYMBICORT) pMDI Drug: Formoterol Turbuhaler	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	A Phase IIIB, 12-Month, Double-blind, Double-dummy,Randomised, Parallel-group, Multicentre Exacerbation Study of SYMBICORT® pMDI 160/4.5 μg x 2 Actuations Twice-daily and 80/4.5 μg x 2 Actuations Twice-daily Compared to Formoterol Turbuhaler® 4.5 μg x 2 Inhalations Twice-daily in COPD Subjects

Resource links provided by NLM:

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

Drug Information available for: Formoterol fumarate Budesonide Arformoterol Formoterol Symbicort Arformoterol Tartrate

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Total Number of Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Per Patient-treatment Year [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Number of COPD-related exacerbations per patient-treatment year. COPD-related exacerbation was defined as worsening COPD that required a course of oral steriods for treatment and/or hospitalization.
Rate of Exacerbations Per Subject-year [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Rate of exacerbations per subject-year

Secondary Outcome Measures:

Pre-dose Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Change in pre-dose FEV1 from baseline to the average of the randomized treatment period, as calculated by averaging treatment period FEV1 values and subtracting the pre-dose value.
Morning Peak Expiratory Flow (PEF) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Change in morning PEF from baseline to the average of the randomized treatment period, as calculated by averaging treatment period PEF values and subtracting the baseline morning PEF value.
Evening PEF [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Change in evening PEF from baseline to the average of the randomized treatment period, as calculated by averaging treatment period PEF values and subtracting the baseline evening PEF value.
Dyspnea Symptom Scores [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Change from baseline of Dyspnea symptoms evaluated using the breathlessness diary, a 5-point Likert-type scale, ranging from 0 to 4 with higher scores indicating a more severe manifestation of the Dyspnea symptom. Change from baseline was calculated by averaging treatment period Dyspnea scores and subtracting the baseline Dyspnea scores.
Use of Rescue Medication [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Change from baseline in the use of beta-2 agonists, as calculated by averaging treatment period inhalations per day and subtracting the baseline number of inhalations per day.
St. George's Respiratory Questionnaire (SGRQ) Score [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Change from baseline in the SGRQ overall score, as calculated by averaging treatment period SGRQ scores and subtracting the baseline SGRQ scores. The SGRQ contains 3 domains: Symptoms (distress due to respiratory symptoms, 8 questions), Activity (disturbance of physical activity, 16 questions), and Impacts (overall impact on daily life and well-being, 26 questions). Lower scores are associated with less severe symptoms.

Enrollment:	1200
Study Start Date:	January 2007
Study Completion Date:	August 2009
Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

A current clinical diagnosis of COPD with COPD symptoms for more than 2 years
Current smoker or smoking history of 10 or more pack years (1 pack year = 20 cigarettes smoked per day for one year)
A history of at least 1 COPD exacerbations requiring a course of steroids and/or antibiotics within 1-12 months before the first visit

Exclusion Criteria:

A history of asthma at or after 18 years of age
A history of allergic rhinitis at or after 18 years of age
Subjects taking oral steroids
Any significant disease or disorder that may jeopardize a subject's safety

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00419744

Show 140 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

Christer Hultquist, MD

AstraZeneca

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Sharafkhaneh A, Southard JG, Goldman M, Uryniak T, Martin UJ. Effect of budesonide/formoterol pMDI on COPD exacerbations: a double-blind, randomized study. Respir Med. 2012 Feb;106(2):257-68. Epub 2011 Oct 26.

ClinicalTrials.gov Identifier:	NCT00419744 History of Changes
Other Study ID Numbers:	D589CC00003
Study First Received:	January 5, 2007
Results First Received:	August 18, 2010
Last Updated:	August 18, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

COPD

Additional relevant MeSH terms:

Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Budesonide
Formoterol
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
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012