A Study to Assess the Efficacy and Safety of Budesonide/Albuterol Metered-dose Inhaler (BDA MDI/PT027) in Adults and Children 4 Years of Age or Older With Asthma
NCT ID: NCT03769090
Last Updated: 2022-09-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
3132 participants
INTERVENTIONAL
2018-12-13
2022-02-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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BDA MDI (PT027) 160/180 μg
Budesonide/albuterol sulfate, BDA MDI, PT027 high dose
Budesonide/albuterol sulfate metered-dose inhaler 160/180 μg
Budesonide/albuterol sulfate combination inhalation aerosol
BDA MDI (PT027) 80/180 μg
Budesonide/albuterol sulfate, BDA MDI, PT027 low dose
Budesonide/albuterol sulfate metered-dose inhaler 80/180 μg
Budesonide/albuterol sulfate combination inhalation aerosol
AS MDI (PT007) 180 µg
Albuterol sulfate MDI, PT007
Albuterol sulfate metered-dose inhaler 180 μg
Albuterol sulfate inhalation aerosol
Interventions
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Budesonide/albuterol sulfate metered-dose inhaler 160/180 μg
Budesonide/albuterol sulfate combination inhalation aerosol
Budesonide/albuterol sulfate metered-dose inhaler 80/180 μg
Budesonide/albuterol sulfate combination inhalation aerosol
Albuterol sulfate metered-dose inhaler 180 μg
Albuterol sulfate inhalation aerosol
Eligibility Criteria
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Inclusion Criteria
2. Physician diagnosis of asthma documented for at least 1 year
3. Receiving 1 of the following scheduled asthma maintenance therapies for 3 months with stable dosing for at least the last 4 weeks before Visit 1:
* Medium-to-high-dose inhaled corticosteroid (ICS)
* Medium-to-high-dose ICS and 1 additional maintenance therapy from the following: leukotriene receptor antagonists (LTRA), long-acting muscarinic antagonists (LAMA), or theophylline
* Low-to-high-dose ICS in combination with long-acting β2-adrenoreceptor agonist (LABA) with or without one additional maintenance therapy from the following: LTRA, LAMA, or theophylline
4. Prebronchodilator forced expiratory volume in 1 second (FEV1) of ≥40 to \<90% predicted normal value for adults and adolescents, and ≥60 to \<100% predicted normal value for subjects aged 4 to 11 years after withholding specified medications including short/rapid-acting β2-adrenoreceptor agonist (SABA)
5. Demonstrate reversibility at Visit 1, with an increase in FEV1 ≥12% (and ≥200 mL for subjects aged ≥18 years) relative to baseline after administration of sponsor provided Ventolin via central spirometry. One re-test for reversibility testing is allowed within the screening period in advance of Visit 2
6. Demonstrate acceptable spirometry performance (i.e., meet American Thoracic Society/European Respiratory Society acceptability/repeatability criteria)
7. A documented history of at least 1 severe asthma exacerbation within 12 months before Visit 1
8. Able to perform acceptable and reproducible peak expiratory flow (PEF) measurements as assessed by the investigator
Exclusion Criteria
2. Oral corticosteroid/SCS use (any dose and any indication) within 6 weeks before Visit 1
3. Chronic use of oral corticosteroids (OCS, ≥3 weeks use in 3 months prior to Visit 1)
4. Having received any marketed (e.g., omalizumab, mepolizumab, reslizumab, benralizumab) or investigational biologic within 3 months or any other prohibited medication
5. Current smokers, former smokers with \>10 pack-years history, or former smokers who stopped smoking \<6 months before Visit 1 (including all forms of tobacco, e-cigarettes \[vaping\], and marijuana)
6. Life-threatening asthma defined as any history of significant asthma episode(s) requiring intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma related syncopal episode(s) within 5 years of Visit 1
7. Historical or current evidence of a clinically significant disease
8. Cancer not in complete remission for at least 5 years
9. Hospitalization for psychiatric disorder or attempted suicide within 1 year of Visit 1
10. History of psychiatric disease, intellectual deficiency, poor motivation, or other conditions if their magnitude is limiting informed consent validity
11. Significant abuse of alcohol or drugs
4 Years
ALL
No
Sponsors
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Bond Avillion 2 Development LP
INDUSTRY
Responsible Party
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Principal Investigators
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Frank Albers, MD, PhD
Role: STUDY_DIRECTOR
Avillion LLP
Locations
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Research Site
Birmingham, Alabama, United States
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Huntsville, Alabama, United States
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Mobile, Alabama, United States
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Montgomery, Alabama, United States
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Scottsboro, Alabama, United States
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Sheffield, Alabama, United States
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Tuscumbia, Alabama, United States
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Glendale, Arizona, United States
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Peoria, Arizona, United States
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Scottsdale, Arizona, United States
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Little Rock, Arkansas, United States
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Bakersfield, California, United States
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Bellflower, California, United States
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Canoga Park, California, United States
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Encinitas, California, United States
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Hawthorne, California, United States
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Long Beach, California, United States
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Los Angeles, California, United States
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Los Angeles, California, United States
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Los Angeles, California, United States
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Newport Beach, California, United States
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Rancho Cucamonga, California, United States
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Redwood City, California, United States
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Sacramento, California, United States
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San Diego, California, United States
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San Francisco, California, United States
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San Jose, California, United States
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Westminster, California, United States
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Aurora, Colorado, United States
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Colorado Springs, Colorado, United States
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Colorado Springs, Colorado, United States
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Denver, Colorado, United States
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Denver, Colorado, United States
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Denver, Colorado, United States
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Waterbury, Connecticut, United States
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Aventura, Florida, United States
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Boynton Beach, Florida, United States
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Cape Coral, Florida, United States
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Clearwater, Florida, United States
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Clearwater, Florida, United States
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DeLand, Florida, United States
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Gainesville, Florida, United States
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Greenacres City, Florida, United States
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Hialeah, Florida, United States
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Kissimmee, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Orlando, Florida, United States
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Orlando, Florida, United States
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Oviedo, Florida, United States
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Palmetto Bay, Florida, United States
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Panama City, Florida, United States
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Pembroke Pines, Florida, United States
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Pembroke Pines, Florida, United States
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St. Petersburg, Florida, United States
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St. Petersburg, Florida, United States
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Albany, Georgia, United States
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Winder, Georgia, United States
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Meridian, Idaho, United States
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Chicago, Illinois, United States
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Normal, Illinois, United States
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Iowa City, Iowa, United States
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Overland Park, Kansas, United States
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Topeka, Kansas, United States
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Owensboro, Kentucky, United States
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Bangor, Maine, United States
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Baltimore, Maryland, United States
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Chevy Chase, Maryland, United States
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White Marsh, Maryland, United States
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Boston, Massachusetts, United States
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Fall River, Massachusetts, United States
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North Dartmouth, Massachusetts, United States
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Ann Arbor, Michigan, United States
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Ann Arbor, Michigan, United States
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Farmington Hills, Michigan, United States
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Flint, Michigan, United States
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Flint, Michigan, United States
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Hamtramck, Michigan, United States
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Rochester, Michigan, United States
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Rochester Hills, Michigan, United States
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Ypsilanti, Michigan, United States
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Hazelwood, Missouri, United States
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St Louis, Missouri, United States
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St Louis, Missouri, United States
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Bellevue, Nebraska, United States
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Bellevue, Nebraska, United States
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Lincoln, Nebraska, United States
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Las Vegas, Nevada, United States
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Brick, New Jersey, United States
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Marlton, New Jersey, United States
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New Brunswick, New Jersey, United States
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Toms River, New Jersey, United States
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Albuquerque, New Mexico, United States
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Brooklyn, New York, United States
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New Hyde Park, New York, United States
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Potsdam, New York, United States
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The Bronx, New York, United States
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Asheville, North Carolina, United States
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Charlotte, North Carolina, United States
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Charlotte, North Carolina, United States
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Charlotte, North Carolina, United States
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Gastonia, North Carolina, United States
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High Point, North Carolina, United States
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Monroe, North Carolina, United States
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Raleigh, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Fargo, North Dakota, United States
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Cincinnati, Ohio, United States
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Cincinnati, Ohio, United States
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Columbus, Ohio, United States
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Dayton, Ohio, United States
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Dayton, Ohio, United States
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Dublin, Ohio, United States
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Mayfield Heights, Ohio, United States
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Edmond, Oklahoma, United States
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Oklahoma City, Oklahoma, United States
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Tulsa, Oklahoma, United States
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Medford, Oregon, United States
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Blue Bell, Pennsylvania, United States
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Erie, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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East Providence, Rhode Island, United States
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Providence, Rhode Island, United States
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Warwick, Rhode Island, United States
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Anderson, South Carolina, United States
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Clinton, South Carolina, United States
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Columbia, South Carolina, United States
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Gaffney, South Carolina, United States
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Greenville, South Carolina, United States
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Mt. Pleasant, South Carolina, United States
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Myrtle Beach, South Carolina, United States
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North Charleston, South Carolina, United States
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Pelzer, South Carolina, United States
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Rock Hill, South Carolina, United States
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Spartanburg, South Carolina, United States
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Austin, Texas, United States
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Austin, Texas, United States
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Beaumont, Texas, United States
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Boerne, Texas, United States
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Conroe, Texas, United States
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Corsicana, Texas, United States
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Dallas, Texas, United States
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Dallas, Texas, United States
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El Paso, Texas, United States
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Galveston, Texas, United States
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Houston, Texas, United States
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Kerrville, Texas, United States
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Live Oak, Texas, United States
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McKinney, Texas, United States
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Pearland, Texas, United States
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San Antonio, Texas, United States
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San Antonio, Texas, United States
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Sherman, Texas, United States
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The Woodlands, Texas, United States
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Tomball, Texas, United States
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Waco, Texas, United States
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Waxahachie, Texas, United States
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Murray, Utah, United States
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Salt Lake City, Utah, United States
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South Burlington, Vermont, United States
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Morgantown, West Virginia, United States
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Greenfield, Wisconsin, United States
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Buenos Aires, , Argentina
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Buenos Aires, , Argentina
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Buenos Aires, , Argentina
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Buenos Aires, , Argentina
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Buenos Aires, , Argentina
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Buenos Aires, , Argentina
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Córdoba, , Argentina
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Lanús, , Argentina
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Mar del Plata, , Argentina
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Mendoza, , Argentina
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Mendoza, , Argentina
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Quilmes, , Argentina
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Rosario, , Argentina
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Rosario, , Argentina
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Rosario, , Argentina
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Salta, , Argentina
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San Fernando, , Argentina
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San Juan Bautista, , Argentina
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San Miguel de Tucumán, , Argentina
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San Miguel de Tucumán, , Argentina
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San Miguel de Tucumán, , Argentina
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Santa Fe, , Argentina
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Santa Fe, , Argentina
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Vancouver, British Columbia, Canada
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Ajax, Ontario, Canada
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Burlington, Ontario, Canada
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Greater Sudbury, Ontario, Canada
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London, Ontario, Canada
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Newmarket, Ontario, Canada
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Toronto, Ontario, Canada
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Waterloo, Ontario, Canada
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Windsor, Ontario, Canada
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Québec, Quebec, Canada
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Beroun, , Czechia
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Brandýs nad Labem, , Czechia
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Jindřichův Hradec, , Czechia
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Kralupy nad Vltavou, , Czechia
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Kuřim, , Czechia
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Lovosice, , Czechia
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Miroslav, , Czechia
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Neratovice, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Rokycany, , Czechia
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Tábor, , Czechia
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Teplice, , Czechia
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Varnsdorf, , Czechia
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Augsburg, , Germany
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Bad Wörishofen, , Germany
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Bamberg, , Germany
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Bergisch Gladbach, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Bonn, , Germany
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Cologne, , Germany
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Cottbus, , Germany
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Darmstadt, , Germany
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Delitzsch, , Germany
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Dortmund, , Germany
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Essen, , Germany
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Frankfurt, , Germany
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Frankfurt, , Germany
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Geesthacht, , Germany
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Gelsenkirchen, , Germany
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Halle, , Germany
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Hamburg, , Germany
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Hamburg, , Germany
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Hanover, , Germany
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Hanover, , Germany
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Homburg, , Germany
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Jena, , Germany
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Leipzig, , Germany
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Leipzig, , Germany
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Leipzig, , Germany
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Leipzig, , Germany
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Leipzig, , Germany
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Lübeck, , Germany
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Lübeck, , Germany
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Magdeburg, , Germany
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Marburg, , Germany
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München, , Germany
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München, , Germany
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Neu-Isenburg, , Germany
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Peine, , Germany
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Potsdam, , Germany
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Radebeul, , Germany
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Reinfeld, , Germany
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Rosenheim, , Germany
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Schleswig, , Germany
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Wiesbaden, , Germany
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Witten, , Germany
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Belgrade, , Serbia
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Kamenitz, , Serbia
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Kragujevac, , Serbia
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Niš, , Serbia
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Valjevo, , Serbia
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Bratislava, , Slovakia
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Ilava, , Slovakia
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Kežmarok, , Slovakia
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Košice, , Slovakia
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Košice, , Slovakia
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Poprad, , Slovakia
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Prešov, , Slovakia
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Žilina, , Slovakia
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Athlone, , South Africa
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Bellville, , South Africa
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Benoni, , South Africa
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Bloemfontein, , South Africa
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Boksburg, , South Africa
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Cape Town, , South Africa
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Cape Town, , South Africa
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Durban, , South Africa
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Durban, , South Africa
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eMkhomazi, , South Africa
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Gatesville, , South Africa
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Johannesburg, , South Africa
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Kempton Park, , South Africa
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Kraaifontein, , South Africa
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Middelburg, , South Africa
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Mowbray, , South Africa
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Newtown, , South Africa
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Parktown, , South Africa
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Pretoria, , South Africa
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Pretoria, , South Africa
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Roodepoort, , South Africa
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Umhlanga, , South Africa
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Witbank, , South Africa
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Barcelona, , Spain
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Barcelona, , Spain
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Barcelona, , Spain
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Barcelona, , Spain
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Girona, , Spain
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Madrid, , Spain
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Mérida, , Spain
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Valencia, , Spain
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Cherkasy, , Ukraine
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Dnipro, , Ukraine
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Ivano-Frankivsk, , Ukraine
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Kharkiv, , Ukraine
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Kharkiv, , Ukraine
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Kharkiv, , Ukraine
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Kherson, , Ukraine
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Kyiv, , Ukraine
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Kyiv, , Ukraine
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Kyiv, , Ukraine
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Lutsk, , Ukraine
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Uzhhorod, , Ukraine
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Vinnytsia, , Ukraine
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Zaporizhzhya, , Ukraine
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Zaporizhzhya, , Ukraine
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Zaporizhzhya, , Ukraine
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Belfast, , United Kingdom
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Blackpool, , United Kingdom
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Bradford, , United Kingdom
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Chippenham, , United Kingdom
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Corby, , United Kingdom
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Corby, , United Kingdom
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Kenilworth, , United Kingdom
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Liverpool, , United Kingdom
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London, , United Kingdom
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Newcastle upon Tyne, , United Kingdom
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Northwood, , United Kingdom
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Nottingham, , United Kingdom
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Peterborough, , United Kingdom
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Romford, , United Kingdom
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Shipley, , United Kingdom
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Sidcup, , United Kingdom
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Wokingham, , United Kingdom
Countries
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References
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Chipps BE, Albers FC, Reilly L, Johnsson E, Cappelletti C, Papi A. Efficacy and safety of as-needed albuterol/budesonide versus albuterol in adults and children aged >/=4 years with moderate-to-severe asthma: rationale and design of the randomised, double-blind, active-controlled MANDALA study. BMJ Open Respir Res. 2021 Dec;8(1):e001077. doi: 10.1136/bmjresp-2021-001077.
Papi A, Chipps BE, Beasley R, Panettieri RA Jr, Israel E, Cooper M, Dunsire L, Jeynes-Ellis A, Johnsson E, Rees R, Cappelletti C, Albers FC. Albuterol-Budesonide Fixed-Dose Combination Rescue Inhaler for Asthma. N Engl J Med. 2022 Jun 2;386(22):2071-2083. doi: 10.1056/NEJMoa2203163. Epub 2022 May 15.
Chipps BE, Panettieri RA Jr, Skolnik N, Cappelletti C, Daoud SZ, Dunsire L, Gilbert IA, Papi A. Albuterol-budesonide rescue inhaler for asthma: Patterns of use and safety in the MANDALA trial. Ann Allergy Asthma Immunol. 2025 Jul 13:S1081-1206(25)00348-5. doi: 10.1016/j.anai.2025.07.008. Online ahead of print.
Kew KM, Flemyng E, Quon BS, Leung C. Increased versus stable doses of inhaled corticosteroids for exacerbations of chronic asthma in adults and children. Cochrane Database Syst Rev. 2022 Sep 26;9(9):CD007524. doi: 10.1002/14651858.CD007524.pub5.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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AV003
Identifier Type: -
Identifier Source: org_study_id
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