A Comparison of SYMBICORT® pMDI With Formoterol Turbuhaler® in Subjects With COPD

August 18, 2010 updated by: AstraZeneca

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Argentina
      • Cordoba, Argentina
        • Research Site
      • Corrientes, Argentina
        • Research Site
      • Mendoza, Argentina
        • Research Site
      • San Juan, Argentina
        • Research Site
    • Buenos Aires
      • 9 de Julio, Buenos Aires, Argentina
        • Research Site
      • Capital Federal, Buenos Aires, Argentina
        • Research Site
      • Mar Del Plata, Buenos Aires, Argentina
        • Research Site
      • Ramos Mejia, Buenos Aires, Argentina
        • Research Site
      • Vicente Lopez, Buenos Aires, Argentina
        • Research Site
    • Tucuman
      • San Miguel de Tucuman, Tucuman, Argentina
        • Research Site
  • Brazil
    • CE
      • Fortaleza, CE, Brazil
        • Research Site
    • GO
      • Goiania, GO, Brazil
        • Research Site
    • PR
      • Curitiba, PR, Brazil
        • Research Site
    • Pernambuco
      • Recife, Pernambuco, Brazil
        • Research Site
    • RJ
      • Rio de Janeiro, RJ, Brazil
        • Research Site
    • RS
      • Porta Alegre, RS, Brazil
        • Research Site
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil
        • Research Site
    • SP
      • Santo Andre, SP, Brazil
        • Research Site
      • Sao Paulo, SP, Brazil
        • Research Site
    • Santa Catarina
      • Florian�polis, Santa Catarina, Brazil
        • Research Site
  • Chile
    • Quinta Region
      • Valparaiso, Quinta Region, Chile
        • Research Site
    • RM
      • Santiago, RM, Chile
        • Research Site
    • Vi Region
      • Rancagua, Vi Region, Chile
        • Research Site
  • Colombia
    • Antioquia
      • Medillin, Antioquia, Colombia
        • Research Site
    • Atl�ntico
      • Barranquilla, Atl�ntico, Colombia
        • Research Site
    • Cundianmarca
      • Bogota Dc, Cundianmarca, Colombia
        • Research Site
  • Mexico
    • Jalisco
      • Guadalajara, Jalisco, Mexico
        • Research Site
  • Peru
      • Lima, Peru
        • Research Site
    • Lima
      • Jesus Maria, Lima, Peru
        • Research Site
      • San Borja, Lima, Peru
        • Research Site
      • Surco, Lima, Peru
        • Research Site
  • South Africa
      • Amanzimtoti, South Africa
        • Research Site
      • Bloemfontein, South Africa
        • Research Site
      • Boksburg, South Africa
        • Research Site
      • Cape Town, South Africa
        • Research Site
      • Centurion, South Africa
        • Research Site
      • Durban, South Africa
        • Research Site
      • Humansdorp, South Africa
        • Research Site
      • Pretoria, South Africa
        • Research Site
      • Pretoria West, South Africa
        • Research Site
      • Roodepoort, South Africa
        • Research Site
    • Cape Town
      • Belvilee, Cape Town, South Africa
        • Research Site
      • Tygerberg, Cape Town, South Africa
        • Research Site
    • E Cape
      • Port Elizabeth, E Cape, South Africa
        • Research Site
    • Port Elizabeth
      • Korsten, Port Elizabeth, South Africa
        • Research Site
    • Pretoria
      • Groenkloof, Pretoria, South Africa
        • Research Site
      • Thaba Tswane, Pretoria, South Africa
        • Research Site
  • United States
    • Alabama
      • Jasper, Alabama, United States
        • Research Site
      • Mobile, Alabama, United States
        • Research Site
    • Arizona
      • Tucson, Arizona, United States
        • Research Site
    • Arkansas
      • Fort Smith, Arkansas, United States
        • Research Site
      • Little Rock, Arkansas, United States
        • Research Site
    • California
      • Anaheim, California, United States
        • Research Site
      • Foothill Ranch, California, United States
        • Research Site
      • Fullerton, California, United States
        • Research Site
      • Long Beach, California, United States
        • Research Site
      • Los Angeles, California, United States
        • Research Site
      • Los Banos, California, United States
        • Research Site
      • Mission Viejo, California, United States
        • Research Site
      • Pismo Beach, California, United States
        • Research Site
      • Rancho Cordova, California, United States
        • Research Site
      • Rancho Mirage, California, United States
        • Research Site
      • Riverside, California, United States
        • Research Site
      • Rolling Hills Estates, California, United States
        • Research Site
      • Sacramento, California, United States
        • Research Site
      • San Diego, California, United States
        • Research Site
      • Sepulveda, California, United States
        • Research Site
      • Torrance, California, United States
        • Research Site
    • Colorado
      • Englewood, Colorado, United States
        • Research Site
      • Wheat Ridge, Colorado, United States
        • Research Site
    • Connecticut
      • Stanford, Connecticut, United States
        • Research Site
    • Florida
      • Deland, Florida, United States
        • Research Site
      • Opalocka, Florida, United States
        • Research Site
      • Orange City, Florida, United States
        • Research Site
      • Orlando, Florida, United States
        • Research Site
      • Panama City, Florida, United States
        • Research Site
      • Pensacola, Florida, United States
        • Research Site
      • Sarasota, Florida, United States
        • Research Site
      • St Cloud, Florida, United States
        • Research Site
    • Georgia
      • Augusta, Georgia, United States
        • Research Site
      • Blue Ridge, Georgia, United States
        • Research Site
      • Marietta, Georgia, United States
        • Research Site
    • Idaho
      • Boise, Idaho, United States
        • Research Site
      • Coeur D'alene, Idaho, United States
        • Research Site
    • Illinois
      • Chicago, Illinois, United States
        • Research Site
    • Iowa
      • Council Bluffs, Iowa, United States
        • Research Site
    • Kansas
      • Witchita, Kansas, United States
        • Research Site
    • Louisiana
      • Marrero, Louisiana, United States
        • Research Site
      • Metairie, Louisiana, United States
        • Research Site
      • Sunset, Louisiana, United States
        • Research Site
    • Maine
      • Bangor, Maine, United States
        • Research Site
    • Massachusetts
      • Pittsfield, Massachusetts, United States
        • Research Site
      • Waltham, Massachusetts, United States
        • Research Site
    • Missouri
      • Chesterfield, Missouri, United States
        • Research Site
      • Florissant, Missouri, United States
        • Research Site
      • Kansas City, Missouri, United States
        • Research Site
      • St. Louis, Missouri, United States
        • Research Site
    • Montana
      • Missoula, Montana, United States
        • Research Site
    • Nebraska
      • Omaha, Nebraska, United States
        • Research Site
      • Papillion, Nebraska, United States
        • Research Site
    • Nevada
      • Las Vegas, Nevada, United States
        • Research Site
    • New Jersey
      • Springfield, New Jersey, United States
        • Research Site
    • New York
      • Bronxville, New York, United States
        • Research Site
      • Elmira, New York, United States
        • Research Site
      • Larchmont, New York, United States
        • Research Site
    • North Carolina
      • Charlotte, North Carolina, United States
        • Research Site
      • Elizabeth City, North Carolina, United States
        • Research Site
      • Hickory, North Carolina, United States
        • Research Site
    • Ohio
      • Chardon, Ohio, United States
        • Research Site
      • Cincinnati, Ohio, United States
        • Research Site
      • Columbus, Ohio, United States
        • Research Site
      • Sylvania, Ohio, United States
        • Research Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
        • Research Site
    • Oregon
      • Medford, Oregon, United States
        • Research Site
      • Portland, Oregon, United States
        • Research Site
    • Pennsylvania
      • Beaver, Pennsylvania, United States
        • Research Site
      • Bensalem, Pennsylvania, United States
        • Research Site
      • Downingtown, Pennsylvania, United States
        • Research Site
      • Harrisburg, Pennsylvania, United States
        • Research Site
      • Landsdale, Pennsylvania, United States
        • Research Site
      • Philadelphia, Pennsylvania, United States
        • Research Site
      • Pittsburgh, Pennsylvania, United States
        • Research Site
      • Warminster, Pennsylvania, United States
        • Research Site
      • Yardley, Pennsylvania, United States
        • Research Site
    • Rhode Island
      • East Providence, Rhode Island, United States
        • Research Site
    • South Carolina
      • Charleston, South Carolina, United States
        • Research Site
      • Gaffney, South Carolina, United States
        • Research Site
      • Greenville, South Carolina, United States
        • Research Site
      • Prosperity, South Carolina, United States
        • Research Site
      • Spartanburg, South Carolina, United States
        • Research Site
      • Union, South Carolina, United States
        • Research Site
    • Tennessee
      • Fayetteville, Tennessee, United States
        • Research Site
    • Texas
      • Boerne, Texas, United States
        • Research Site
      • Houston, Texas, United States
        • Research Site
      • McKinney, Texas, United States
        • Research Site
      • San Antonio, Texas, United States
        • Research Site
    • Virginia
      • Abingdon, Virginia, United States
        • Research Site
    • Washington
      • Spokane, Washington, United States
        • Research Site
      • Tacoma, Washington, United States
        • Research Site
  • Venezuela
    • Caracas
      • Distrito Capital, Caracas, Venezuela
        • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Double

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Total Number of Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Per Patient-treatment Year
Time Frame: 12 months
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.
12 months
Rate of Exacerbations Per Subject-year
Time Frame: 12 months
Rate of exacerbations per subject-year
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pre-dose Forced Expiratory Volume in 1 Second (FEV1)
Time Frame: 12 months
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.
12 months
Morning Peak Expiratory Flow (PEF)
Time Frame: 12 months
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.
12 months
Evening PEF
Time Frame: 12 months
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.
12 months
Dyspnea Symptom Scores
Time Frame: 12 months
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.
12 months
Use of Rescue Medication
Time Frame: 12 months
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.
12 months
St. George's Respiratory Questionnaire (SGRQ) Score
Time Frame: 12 months
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.
12 months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Christer Hultquist, MD, AstraZeneca

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

Helpful Links

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 5, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 9, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 16, 2010

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 18, 2010

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D589CC00003

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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