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

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1200

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

  • 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

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

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

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

AstraZeneca

Investigators

  • 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

January 1, 2007

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

January 5, 2007

First Submitted That Met QC Criteria

January 5, 2007

First Posted (Estimate)

January 9, 2007

Study Record Updates

Last Update Posted (Estimate)

September 16, 2010

Last Update Submitted That Met QC Criteria

August 18, 2010

Last Verified

August 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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