Back to resultsA Comparison of SYMBICORT® pMDI With Formoterol Turbuhaler® in Subjects With COPD
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Budesonide/formoterol (SYMBICORT) pMDI
Formoterol Turbuhaler
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD
Eligibility 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
Sites / Locations
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Outcomes
Primary Outcome Measures
Total Number of Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Per Patient-treatment Year
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
Rate of exacerbations per subject-year
Secondary Outcome Measures
Pre-dose Forced Expiratory Volume in 1 Second (FEV1)
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)
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
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
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
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00419744
Brief Title
A Comparison of SYMBICORT® pMDI With Formoterol Turbuhaler® in Subjects With COPD
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2010
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
COPD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
1200 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Budesonide/formoterol (SYMBICORT) pMDI
Intervention Type
Drug
Intervention Name(s)
Formoterol Turbuhaler
Primary Outcome Measure Information:
Title
Total Number of Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Per Patient-treatment Year
Description
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.
Time Frame
12 months
Title
Rate of Exacerbations Per Subject-year
Description
Rate of exacerbations per subject-year
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Pre-dose Forced Expiratory Volume in 1 Second (FEV1)
Description
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.
Time Frame
12 months
Title
Morning Peak Expiratory Flow (PEF)
Description
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.
Time Frame
12 months
Title
Evening PEF
Description
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.
Time Frame
12 months
Title
Dyspnea Symptom Scores
Description
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.
Time Frame
12 months
Title
Use of Rescue Medication
Description
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.
Time Frame
12 months
Title
St. George's Respiratory Questionnaire (SGRQ) Score
Description
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.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christer Hultquist, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
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Jasper
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Alabama
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United States
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Mobile
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Tucson
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Gaffney
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Greenville
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Prosperity
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Union
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Abingdon
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Spokane
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Tacoma
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United States
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Argentina
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Capital Federal
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Argentina
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Mar Del Plata
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Argentina
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Ramos Mejia
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Argentina
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Vicente Lopez
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Buenos Aires
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Argentina
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San Miguel de Tucuman
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Tucuman
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Argentina
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Cordoba
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Argentina
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Corrientes
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Argentina
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Mendoza
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Argentina
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San Juan
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Argentina
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Fortaleza
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Brazil
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Goiania
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Brazil
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Recife
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Brazil
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Curitiba
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Brazil
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Porto Alegre
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Brazil
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Rio de Janeiro
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Brazil
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Porta Alegre
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Brazil
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Florian�polis
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Santa Catarina
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Brazil
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Santo Andre
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SP
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Brazil
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Sao Paulo
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SP
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Brazil
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Valparaiso
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Quinta Region
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Chile
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Santiago
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RM
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Chile
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Rancagua
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Chile
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Medillin
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Antioquia
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Colombia
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Barranquilla
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Atl�ntico
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Colombia
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Bogota Dc
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Cundianmarca
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Colombia
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Guadalajara
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Jalisco
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Mexico
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Jesus Maria
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Lima
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Peru
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San Borja
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Lima
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Peru
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Surco
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Lima
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Peru
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Lima
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Peru
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Belvilee
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Cape Town
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South Africa
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Tygerberg
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Cape Town
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South Africa
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Port Elizabeth
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E Cape
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South Africa
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Korsten
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Port Elizabeth
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South Africa
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Groenkloof
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Pretoria
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South Africa
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Thaba Tswane
State/Province
Pretoria
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South Africa
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Amanzimtoti
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South Africa
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Bloemfontein
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South Africa
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Boksburg
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South Africa
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Cape Town
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South Africa
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Centurion
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South Africa
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Durban
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South Africa
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Humansdorp
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South Africa
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Pretoria West
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South Africa
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Pretoria
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South Africa
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Roodepoort
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South Africa
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Distrito Capital
State/Province
Caracas
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Venezuela
12. IPD Sharing Statement
Citations:
PubMed Identifier
29331313
Citation
Bafadhel M, Peterson S, De Blas MA, Calverley PM, Rennard SI, Richter K, Fageras M. Predictors of exacerbation risk and response to budesonide in patients with chronic obstructive pulmonary disease: a post-hoc analysis of three randomised trials. Lancet Respir Med. 2018 Feb;6(2):117-126. doi: 10.1016/S2213-2600(18)30006-7. Epub 2018 Jan 10.
Results Reference
derived
PubMed Identifier
26293575
Citation
Jenkins CR, Postma DS, Anzueto AR, Make BJ, Peterson S, Eriksson G, Calverley PM. Reliever salbutamol use as a measure of exacerbation risk in chronic obstructive pulmonary disease. BMC Pulm Med. 2015 Aug 21;15:97. doi: 10.1186/s12890-015-0077-0.
Results Reference
derived
PubMed Identifier
25670896
Citation
Make BJ, Eriksson G, Calverley PM, Jenkins CR, Postma DS, Peterson S, Ostlund O, Anzueto A. A score to predict short-term risk of COPD exacerbations (SCOPEX). Int J Chron Obstruct Pulmon Dis. 2015 Jan 27;10:201-9. doi: 10.2147/COPD.S69589. eCollection 2015.
Results Reference
derived
PubMed Identifier
22033040
Citation
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. doi: 10.1016/j.rmed.2011.07.020. Epub 2011 Oct 26.
Results Reference
derived
Links:
URL
http://www.copdclinicalresearch.com/
Description
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A Comparison of SYMBICORT® pMDI With Formoterol Turbuhaler® in Subjects With COPD
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