Chronic Obstructive Pulmonary Disease Clinical Trial
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
Verified date | August 2010 |
Source | AstraZeneca |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 1200 |
Est. completion date | August 2009 |
Est. primary completion date | August 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 40 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Argentina | Research Site | 9 de Julio | Buenos Aires |
Argentina | Research Site | Capital Federal | Buenos Aires |
Argentina | Research Site | Cordoba | |
Argentina | Research Site | Corrientes | |
Argentina | Research Site | Mar Del Plata | Buenos Aires |
Argentina | Research Site | Mendoza | |
Argentina | Research Site | Ramos Mejia | Buenos Aires |
Argentina | Research Site | San Juan | |
Argentina | Research Site | San Miguel de Tucuman | Tucuman |
Argentina | Research Site | Vicente Lopez | Buenos Aires |
Brazil | Research Site | Curitiba | PR |
Brazil | Research Site | Florian?polis | Santa Catarina |
Brazil | Research Site | Fortaleza | CE |
Brazil | Research Site | Goiania | GO |
Brazil | Research Site | Porta Alegre | RS |
Brazil | Research Site | Porto Alegre | Rio Grande Do Sul |
Brazil | Research Site | Recife | Pernambuco |
Brazil | Research Site | Rio de Janeiro | RJ |
Brazil | Research Site | Santo Andre | SP |
Brazil | Research Site | Sao Paulo | SP |
Chile | Research Site | Rancagua | Vi Region |
Chile | Research Site | Santiago | RM |
Chile | Research Site | Valparaiso | Quinta Region |
Colombia | Research Site | Barranquilla | Atl?ntico |
Colombia | Research Site | Bogota Dc | Cundianmarca |
Colombia | Research Site | Medillin | Antioquia |
Mexico | Research Site | Guadalajara | Jalisco |
Peru | Research Site | Jesus Maria | Lima |
Peru | Research Site | Lima | |
Peru | Research Site | San Borja | Lima |
Peru | Research Site | Surco | Lima |
South Africa | Research Site | Amanzimtoti | |
South Africa | Research Site | Belvilee | Cape Town |
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 | Groenkloof | Pretoria |
South Africa | Research Site | Humansdorp | |
South Africa | Research Site | Korsten | Port Elizabeth |
South Africa | Research Site | Port Elizabeth | E Cape |
South Africa | Research Site | Pretoria | |
South Africa | Research Site | Pretoria West | |
South Africa | Research Site | Roodepoort | |
South Africa | Research Site | Thaba Tswane | Pretoria |
South Africa | Research Site | Tygerberg | Cape Town |
United States | Research Site | Abingdon | Virginia |
United States | Research Site | Anaheim | California |
United States | Research Site | Augusta | Georgia |
United States | Research Site | Bangor | Maine |
United States | Research Site | Beaver | Pennsylvania |
United States | Research Site | Bensalem | Pennsylvania |
United States | Research Site | Blue Ridge | Georgia |
United States | Research Site | Boerne | Texas |
United States | Research Site | Boise | Idaho |
United States | Research Site | Bronxville | New York |
United States | Research Site | Chardon | Ohio |
United States | Research Site | Charleston | South Carolina |
United States | Research Site | Charlotte | North Carolina |
United States | Research Site | Chesterfield | Missouri |
United States | Research Site | Chicago | Illinois |
United States | Research Site | Cincinnati | Ohio |
United States | Research Site | Coeur D'alene | Idaho |
United States | Research Site | Columbus | Ohio |
United States | Research Site | Council Bluffs | Iowa |
United States | Research Site | Deland | Florida |
United States | Research Site | Downingtown | Pennsylvania |
United States | Research Site | East Providence | Rhode Island |
United States | Research Site | Elizabeth City | North Carolina |
United States | Research Site | Elmira | New York |
United States | Research Site | Englewood | Colorado |
United States | Research Site | Fayetteville | Tennessee |
United States | Research Site | Florissant | Missouri |
United States | Research Site | Foothill Ranch | California |
United States | Research Site | Fort Smith | Arkansas |
United States | Research Site | Fullerton | California |
United States | Research Site | Gaffney | South Carolina |
United States | Research Site | Greenville | South Carolina |
United States | Research Site | Harrisburg | Pennsylvania |
United States | Research Site | Hickory | North Carolina |
United States | Research Site | Houston | Texas |
United States | Research Site | Jasper | Alabama |
United States | Research Site | Kansas City | Missouri |
United States | Research Site | Landsdale | Pennsylvania |
United States | Research Site | Larchmont | New York |
United States | Research Site | Las Vegas | Nevada |
United States | Research Site | Little Rock | Arkansas |
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 | Marietta | Georgia |
United States | Research Site | Marrero | Louisiana |
United States | Research Site | McKinney | Texas |
United States | Research Site | Medford | Oregon |
United States | Research Site | Metairie | Louisiana |
United States | Research Site | Mission Viejo | California |
United States | Research Site | Missoula | Montana |
United States | Research Site | Mobile | Alabama |
United States | Research Site | Oklahoma City | Oklahoma |
United States | Research Site | Omaha | Nebraska |
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 | Papillion | Nebraska |
United States | Research Site | Pensacola | Florida |
United States | Research Site | Philadelphia | Pennsylvania |
United States | Research Site | Pismo Beach | California |
United States | Research Site | Pittsburgh | Pennsylvania |
United States | Research Site | Pittsfield | Massachusetts |
United States | Research Site | Portland | Oregon |
United States | Research Site | Prosperity | South Carolina |
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 Antonio | Texas |
United States | Research Site | San Diego | California |
United States | Research Site | Sarasota | Florida |
United States | Research Site | Sepulveda | California |
United States | Research Site | Spartanburg | South Carolina |
United States | Research Site | Spokane | Washington |
United States | Research Site | Springfield | New Jersey |
United States | Research Site | St Cloud | Florida |
United States | Research Site | St. Louis | Missouri |
United States | Research Site | Stanford | Connecticut |
United States | Research Site | Sunset | Louisiana |
United States | Research Site | Sylvania | Ohio |
United States | Research Site | Tacoma | Washington |
United States | Research Site | Torrance | California |
United States | Research Site | Tucson | Arizona |
United States | Research Site | Union | South Carolina |
United States | Research Site | Waltham | Massachusetts |
United States | Research Site | Warminster | Pennsylvania |
United States | Research Site | Wheat Ridge | Colorado |
United States | Research Site | Witchita | Kansas |
United States | Research Site | Yardley | Pennsylvania |
Venezuela | Research Site | Distrito Capital | Caracas |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca |
United States, Venezuela, Argentina, Brazil, Chile, Colombia, Mexico, Peru, South Africa,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 12 months | No |
Primary | Rate of Exacerbations Per Subject-year | Rate of exacerbations per subject-year | 12 months | No |
Secondary | 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. | 12 months | No |
Secondary | 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. | 12 months | No |
Secondary | 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. | 12 months | No |
Secondary | 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. | 12 months | No |
Secondary | 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. | 12 months | No |
Secondary | 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. | 12 months | No |
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