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 |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05102305 -
A Multi-center,Prospective, OS to Evaluate the Effectiveness of 'NAC' Nebulizer Therapy in COPD (NEWEST)
|
||
| Completed |
NCT01867762 -
An Effectiveness and Safety Study of Inhaled JNJ 49095397 (RV568) in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
|
Phase 2 | |
| Recruiting |
NCT05562037 -
Stepped Care vs Center-based Cardiopulmonary Rehabilitation for Older Frail Adults Living in Rural MA
|
N/A | |
| Terminated |
NCT04921332 -
Bright Light Therapy for Depression Symptoms in Adults With Cystic Fibrosis (CF) and COPD
|
N/A | |
| Completed |
NCT03089515 -
Small Airway Chronic Obstructive Disease Syndrome Following Exposure to WTC Dust
|
N/A | |
| Completed |
NCT02787863 -
Clinical and Immunological Efficiency of Bacterial Vaccines at Adult Patients With Bronchopulmonary Pathology
|
Phase 4 | |
| Recruiting |
NCT05552833 -
Pulmonary Adaptive Responses to HIIT in COPD
|
N/A | |
| Recruiting |
NCT05835492 -
A Pragmatic Real-world Multicentre Observational Research Study to Explore the Clinical and Health Economic Impact of myCOPD
|
||
| Recruiting |
NCT05631132 -
May Noninvasive Mechanical Ventilation (NIV) and/or Continuous Positive Airway Pressure (CPAP) Increase the Bronchoalveolar Lavage (BAL) Salvage in Patients With Pulmonary Diseases?
|
N/A | |
| Completed |
NCT03244137 -
Effects of Pulmonary Rehabilitation on Cognitive Function in Patients With Severe to Very Severe Chronic Obstructive Pulmonary Disease
|
||
| Not yet recruiting |
NCT03282526 -
Volume Parameters vs Flow Parameters in Assessment of Reversibility in Chronic Obstructive Pulmonary Disease
|
N/A | |
| Completed |
NCT02546700 -
A Study to Evaluate Safety and Efficacy of Lebrikizumab in Participants With Chronic Obstructive Pulmonary Disease (COPD)
|
Phase 2 | |
| Withdrawn |
NCT04446637 -
Acute Bronchodilator Effects of Ipratropium/Levosalbutamol 20/50 mcg Fixed Dose Combination vs Salbutamol 100 mcg Inhaler Plus Ipratropium 20 mcg Inhalation Aerosol Free Combination in Patients With Stable COPD
|
Phase 3 | |
| Completed |
NCT04535986 -
A Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of Ensifentrine in Patients With COPD
|
Phase 3 | |
| Recruiting |
NCT05865184 -
Evaluation of Home-based Sensor System to Detect Health Decompensation in Elderly Patients With History of CHF or COPD
|
||
| Completed |
NCT03256695 -
Evaluate the Relationship Between Use of Albuterol Multidose Dry Powder Inhaler With an eModule (eMDPI) and Exacerbations in Participants With Chronic Obstructive Pulmonary Disease (COPD)
|
Phase 3 | |
| Completed |
NCT03295474 -
Telemonitoring in Pulmonary Rehabilitation: Feasibility and Acceptability of a Remote Pulse Oxymetry System.
|
||
| Withdrawn |
NCT04042168 -
Implications of Appropriate Use of Inhalers in Chronic Obstructive Pulmonary Disease (COPD)
|
Phase 4 | |
| Completed |
NCT03414541 -
Safety And Efficacy Study Of Orally Administered DS102 In Patients With Chronic Obstructive Pulmonary Disease
|
Phase 2 | |
| Completed |
NCT02552160 -
DETECT-Register DocumEnTation and Evaluation of a COPD Combination Therapy
|