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Long Term Safety Study of Levalbuterol and Racemic Albuterol in Subjects Twelve Years of Age and Older With Asthma

Primary Purpose

Asthma

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
levalbuterol tartrate HFA MDI
racemic albuterol
Sponsored by
Sumitomo Pharma America, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria Willing and able to comply with study procedures and visit schedules Females 12-60 yrs must have a negative serum pregnancy test at study start Women of child bearing potential must use acceptable method of birth control throughout study Confirmed diagnosis of asthma minimum of 6 mos. prior to study start Have stable baseline asthma and have been using B-adrenergic agonist, and/or anti-asthma anti-inflammatory meds, and/or OTC asthma meds. >6 mos. prior to study start In good health with exception of reversible airways disease and not suffering from any chronic condition that might affect their respiratory function Had chest X-ray w/in 12 mos. prior to randomization that is not diagnostic of pneumonia, atelectasis, pulmonary fibrotic disease, pneumothorax, chronic obstructive pulmonary disease etc. Subject rolling over from either Sepracor study 051-353 or 051-355 must have successfully completed the study Subject who is not immediately rolled over from Sepracor study 051-353 or 051-355 must wait >30 days and will be regarded as a de novo subject Able to complete daily diary cards and medical event calendars reliably, understand dosing instructions, demonstrate how to use the MiniWright PEF meter. Minor subjects must have a parent/legal guardian assist them during the study with these activities Exclusion Criteria Female who is pregnant or lactating Participated in investigational drug study w/in 30 days prior to study start, or currently participating in another clinical trial, other than Sepracor studies 051-353 or 051-355 Subject who early terminated from Sepracor study 051-353 or 051-355 Subject whose schedule prevents him or her from taking the first daily dose of study medication and/or starting study visits before 10 AM Have travel commitments during the study that would interfere with trial measurements and/or compliance History of hospitalization for asthma w/in 45 days prior to study start, or scheduled for in-patient hospitalization, including elective surgery during the trial Subject with a known sensitivity to levalbuterol or racemic albuterol, or any of the excipients contained in any of these formulations Subject using any prescription drug with which albuterol sulfate is contraindicated Subject with currently diagnosed life-threatening asthma History of cancer (exception: basal cell carcinoma in remission) Subject with hyperthyroidism, diabetes, hypertension, cardiac diseases or seizure disorders that currently are not well controlled by medication or may interfere with the successful completion of this protocol History of substance abuse or drug abuse within 12 months preceding V1 Subject with >10 pack/yr history of cigarette smoking or use of any tobacco products within 6 months of study start Documented history of bronchopulmonary aspergillosis or any form of allergic alveolitis Have suffered from a clinically significant upper or lower respiratory tract infection in the 2 weeks prior to study start Subject who is a staff member or relative of a staff member

Sites / Locations

  • Jefferson Clinic PC
  • Pulmonary Associates Research Division
  • Montgomery Pulmonary Consultants
  • Center of Research Excellence, LLC
  • Lovelace Scientific Resources
  • Alta Clinical Research, LLC
  • Integrated Research Group
  • Northern California Research Corp
  • Allergy, Asthma & Respiratory Care Center
  • Madera Family Medical Group
  • Clinical Trials of Orange County, Inc.
  • Institute of Healthcare Assessment, Inc.
  • Westlake Medical Research, Inc.
  • Office of Constantine Falliers, MD
  • Office of Gary Richmond, MD
  • CNS Clinical Trials
  • FPA Clinical Research
  • Orlando Clinic for Asthma & Respiratory Diseases
  • Allergy Sinus Asthma Research Institute
  • Florida Center for Alergy & Asthma Research
  • Orlando Clinical Research Center
  • Family Allergy & Asthma Center, PC
  • The Allergy & Asthma Clinic Research Center
  • Aeroallergy Research
  • Sneeze, Wheeze and Itch, LLC
  • Rush Presbyterian - St. Luke's Medical Center
  • Children's Asthma Respiratory & Exercise Specialists
  • Cardinal Respiratory, PC
  • Clinical Research Center of Indiana
  • South Bend Clinic
  • Consultants in Pulmonary Medicine
  • Heartland Research Associates
  • Northshore Medical Research
  • Institute for Asthma & Allergy, PC
  • Center for Clinical Research
  • Henry Ford Hospital & Medical Centers
  • Hurley Child and Adolescent Asthma Center
  • Clinical Research Institute
  • Allergy, Asthma, Immunology Services, LLC
  • Midwest Chest Consultants, PC
  • Washington University School of Medicine, Division of Allergy & Immunology
  • Montana Medical Research, LLC
  • Allergy, Asthma & Immunology Associates, PC
  • Heartland Clinical Research Inc.
  • Office of Meera Dewan, MD
  • Delaware Valley Institute for Clinical Research
  • Clinical Research Center of Allergy & Asthma Consultants
  • Lovelace Scientific Resources
  • Allergy & Asthma of Northern NM
  • Pulmonary Medical Research of NY
  • Asthma & Allergy Associates, PC
  • Office of Michael Marcus, MD
  • Office of Richard Castaldo
  • Regional Allergy & Asthma Consultants
  • Charlotte Lung & Health Center
  • Neem Research Group, Inc.
  • Cornerstone Research Care
  • Carolina MedTrials, LLC
  • Allergy & Asthma Care Center
  • Sterling Research Group
  • New Horizons Clinical Research
  • Optimed Research LLC
  • Allergy, Asthma & Clinical Research Center
  • Allergy, Asthma and Dermatology Research Center
  • Medford Medical Clinic, LLP
  • Bellevue Pediatric Associates
  • Valley Clinical Research Center
  • Allergy & Asthma Research of NJ, Inc.
  • Temple University Hospital
  • Advanced Clinical Concepts
  • Neem Research Group of Charleston
  • Neem Research Group Inc.
  • Allergic Disease & Asthma Center, PA
  • Asthma Institute
  • The Allergy Associates
  • Office of Constantine Saadeh
  • Allergy & Asthma Clinical of Central Texas
  • UTX Medical
  • Breco Research
  • Breath of Life Research Institute
  • Clinical Trials of North Houston
  • Central Texas Health Research
  • Lung Diagnostics
  • Hampton Roads Center for Clinical Research
  • Pulmonary Associates of Richmond Inc.
  • Virginia Adult & Pediatric Allergy & Asthma PC
  • National Clinical Research
  • The Physician's Clinic of Spokane
  • Allergy, Asthma, and Sinus Center F.C.
  • Milwaukee Medical Clinic
  • Allergic Diseases, S.C.
  • Trial Management Group
  • St. Boniface General Hospital
  • Clinical Research Group
  • Niagara Clinical Research, Inc.
  • Primary Care Lung Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

levalbuterol 90 mcg MDI QID

racemic albuterol HFA MDI 180 mcg QID

Outcomes

Primary Outcome Measures

incidence of post-randomization adverse events

Secondary Outcome Measures

rate of discontinuations due to adverse events
time-to-selected adverse events (AEs with an incidence ≥5%)
asthma attacks, asthma adverse events, and expanded-definition asthma events
clinical laboratory values
vital signs (blood pressure, heart rate, respiration rate, and body temperature)
ECG parameters
physical examinations
rescue medication, and daytime asthma control days
FEV1, FVC, FEF25-75%, peak expiratory flow
Asthma Quality of Life Questionnaire (AQLQ)
subject and physician global evaluations
(S) and (R) albuterol plasma concentrations
subject assessment of study inhaler device performance

Full Information

First Posted
July 8, 2003
Last Updated
February 21, 2012
Sponsor
Sumitomo Pharma America, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00064389
Brief Title
Long Term Safety Study of Levalbuterol and Racemic Albuterol in Subjects Twelve Years of Age and Older With Asthma
Official Title
Long Term Safety Study of Levalbuterol and Racemic Albuterol in Subjects Twelve Years of Age and Older With Asthma
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
July 2005 (Actual)
Study Completion Date
July 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sumitomo Pharma America, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the safety of levalbuterol as compared to racemic albuterol based on the frequencies of adverse events reporting during a 12-month period of chronic dosing of adolescent and adult subjects with asthma.
Detailed Description
This was a randomized, open-label, active controlled, multicenter, parallel-group safety study in subjects 12 years of age and older with asthma. Subjects of appropriate age who completed the Phase III levalbuterol HFA MDI trials (Studies 051-353 or 051-355) were eligible to participate. Studies 051-353 and 051-355, both entitled "An Efficacy and Safety Study of Levalbuterol, Racemic Albuterol and Placebo in Subjects Twelve Years of Age and Older with Asthma" were multicenter, randomized, double-blind, placebo- and active-controlled, parallel-group studies of up to nine weeks in duration (a one-week single-blind placebo run in period followed by an eight-week double-blind treatment period). Subjects who completed Studies 051 353 and 051 355 but who were not immediately eligible to rollover into the current study could also participate but only after a 30-day washout. New subjects and subjects who participated in the Phase III trials who were not immediately eligible (ie, had a >30-day washout) were considered to be de novo subjects.Study participation included 10 study visits over a 12 month period. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
746 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
levalbuterol 90 mcg MDI QID
Arm Title
2
Arm Type
Active Comparator
Arm Description
racemic albuterol HFA MDI 180 mcg QID
Intervention Type
Drug
Intervention Name(s)
levalbuterol tartrate HFA MDI
Other Intervention Name(s)
Xopenex HFA MDI
Intervention Description
levalbuterol MDI 90 mcg QID
Intervention Type
Drug
Intervention Name(s)
racemic albuterol
Intervention Description
racemic albuterol HFA MDI 180 mcg QID
Primary Outcome Measure Information:
Title
incidence of post-randomization adverse events
Time Frame
Weeks -1, 0, 1, 2, 3, 10, 11, 18, 19, 22, 23, 26, 27, 30, 31, 34, 35, 38, 39, 43, 44, 47, 48, 52, 53
Secondary Outcome Measure Information:
Title
rate of discontinuations due to adverse events
Time Frame
Weeks -1, 0, 1, 2, 3, 10, 11, 18, 19, 22, 23, 26, 27, 30, 31, 34, 35, 38, 39, 43, 44, 47, 48, 52, 53
Title
time-to-selected adverse events (AEs with an incidence ≥5%)
Time Frame
Weeks -1, 0, 1, 2, 3, 10, 11, 18, 19, 22, 23, 26, 27, 30, 31, 34, 35, 38, 39, 43, 44, 47, 48, 52, 53
Title
asthma attacks, asthma adverse events, and expanded-definition asthma events
Time Frame
Weeks -1, 0, 1, 2, 3, 10, 11, 18, 19, 22, 23, 26, 27, 30, 31, 34, 35, 38, 39, 43, 44, 47, 48, 52, 53
Title
clinical laboratory values
Time Frame
Weeks -1, 0, 10, 11, 26, 27, 43, 44, 52, 53
Title
vital signs (blood pressure, heart rate, respiration rate, and body temperature)
Time Frame
Weeks -1, 0, 1, 2, 3, 10, 11, 18, 19, 26, 27, 34, 35, 43, 44, 52, 53
Title
ECG parameters
Time Frame
Weeks -1, 0, 1, 10, 11, 26, 27, 43, 44, 52, 53
Title
physical examinations
Time Frame
Weeks -1, 0, 26, 27, 52, 53
Title
rescue medication, and daytime asthma control days
Time Frame
Weeks -1, 0, 1, 2, 3, 10, 11, 18, 19, 22, 23, 26, 27, 30, 31, 34, 35, 38, 39, 43, 44, 47, 48, 52, 53
Title
FEV1, FVC, FEF25-75%, peak expiratory flow
Time Frame
Weeks -1, 0, 1, 2, 3, 10, 11, 18, 19, 26, 27, 34, 35, 43, 44, 52, 53
Title
Asthma Quality of Life Questionnaire (AQLQ)
Time Frame
Weeks 0, 26, 27, 52, 53
Title
subject and physician global evaluations
Time Frame
Weeks 26, 27, 52, 53
Title
(S) and (R) albuterol plasma concentrations
Time Frame
Weeks -1, 0, 10, 11, 26, 27, 43, 44, 52, 53
Title
subject assessment of study inhaler device performance
Time Frame
Weeks -1, 0, 1, 2, 3, 10, 11, 18, 19, 22, 23, 26, 27, 30, 31, 34, 35, 38, 39, 43, 44, 47, 48, 52, 53

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Willing and able to comply with study procedures and visit schedules Females 12-60 yrs must have a negative serum pregnancy test at study start Women of child bearing potential must use acceptable method of birth control throughout study Confirmed diagnosis of asthma minimum of 6 mos. prior to study start Have stable baseline asthma and have been using B-adrenergic agonist, and/or anti-asthma anti-inflammatory meds, and/or OTC asthma meds. >6 mos. prior to study start In good health with exception of reversible airways disease and not suffering from any chronic condition that might affect their respiratory function Had chest X-ray w/in 12 mos. prior to randomization that is not diagnostic of pneumonia, atelectasis, pulmonary fibrotic disease, pneumothorax, chronic obstructive pulmonary disease etc. Subject rolling over from either Sepracor study 051-353 or 051-355 must have successfully completed the study Subject who is not immediately rolled over from Sepracor study 051-353 or 051-355 must wait >30 days and will be regarded as a de novo subject Able to complete daily diary cards and medical event calendars reliably, understand dosing instructions, demonstrate how to use the MiniWright PEF meter. Minor subjects must have a parent/legal guardian assist them during the study with these activities Exclusion Criteria Female who is pregnant or lactating Participated in investigational drug study w/in 30 days prior to study start, or currently participating in another clinical trial, other than Sepracor studies 051-353 or 051-355 Subject who early terminated from Sepracor study 051-353 or 051-355 Subject whose schedule prevents him or her from taking the first daily dose of study medication and/or starting study visits before 10 AM Have travel commitments during the study that would interfere with trial measurements and/or compliance History of hospitalization for asthma w/in 45 days prior to study start, or scheduled for in-patient hospitalization, including elective surgery during the trial Subject with a known sensitivity to levalbuterol or racemic albuterol, or any of the excipients contained in any of these formulations Subject using any prescription drug with which albuterol sulfate is contraindicated Subject with currently diagnosed life-threatening asthma History of cancer (exception: basal cell carcinoma in remission) Subject with hyperthyroidism, diabetes, hypertension, cardiac diseases or seizure disorders that currently are not well controlled by medication or may interfere with the successful completion of this protocol History of substance abuse or drug abuse within 12 months preceding V1 Subject with >10 pack/yr history of cigarette smoking or use of any tobacco products within 6 months of study start Documented history of bronchopulmonary aspergillosis or any form of allergic alveolitis Have suffered from a clinically significant upper or lower respiratory tract infection in the 2 weeks prior to study start Subject who is a staff member or relative of a staff member
Facility Information:
Facility Name
Jefferson Clinic PC
City
Birmington
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Pulmonary Associates Research Division
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Montgomery Pulmonary Consultants
City
Montgomery
State/Province
Alabama
ZIP/Postal Code
36111
Country
United States
Facility Name
Center of Research Excellence, LLC
City
Oxford
State/Province
Alabama
ZIP/Postal Code
36203
Country
United States
Facility Name
Lovelace Scientific Resources
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
Alta Clinical Research, LLC
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85745
Country
United States
Facility Name
Integrated Research Group
City
Corona
State/Province
California
ZIP/Postal Code
92506
Country
United States
Facility Name
Northern California Research Corp
City
Fair Oaks
State/Province
California
ZIP/Postal Code
95628
Country
United States
Facility Name
Allergy, Asthma & Respiratory Care Center
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Madera Family Medical Group
City
Madera
State/Province
California
ZIP/Postal Code
93637
Country
United States
Facility Name
Clinical Trials of Orange County, Inc.
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Institute of Healthcare Assessment, Inc.
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
Westlake Medical Research, Inc.
City
Westlake Village
State/Province
California
ZIP/Postal Code
91361
Country
United States
Facility Name
Office of Constantine Falliers, MD
City
Denver
State/Province
Colorado
ZIP/Postal Code
80209
Country
United States
Facility Name
Office of Gary Richmond, MD
City
Ft. Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
Facility Name
CNS Clinical Trials
City
Ft. Myers
State/Province
Florida
ZIP/Postal Code
33907
Country
United States
Facility Name
FPA Clinical Research
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34741
Country
United States
Facility Name
Orlando Clinic for Asthma & Respiratory Diseases
City
Longwood
State/Province
Florida
ZIP/Postal Code
32750
Country
United States
Facility Name
Allergy Sinus Asthma Research Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
Florida Center for Alergy & Asthma Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Orlando Clinical Research Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Family Allergy & Asthma Center, PC
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
The Allergy & Asthma Clinic Research Center
City
Conyers
State/Province
Georgia
ZIP/Postal Code
30013
Country
United States
Facility Name
Aeroallergy Research
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31046
Country
United States
Facility Name
Sneeze, Wheeze and Itch, LLC
City
Bloomington
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States
Facility Name
Rush Presbyterian - St. Luke's Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Children's Asthma Respiratory & Exercise Specialists
City
Glenview
State/Province
Illinois
ZIP/Postal Code
60025
Country
United States
Facility Name
Cardinal Respiratory, PC
City
Springfield
State/Province
Illinois
Country
United States
Facility Name
Clinical Research Center of Indiana
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46208
Country
United States
Facility Name
South Bend Clinic
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46617
Country
United States
Facility Name
Consultants in Pulmonary Medicine
City
Olathe
State/Province
Kansas
ZIP/Postal Code
66061
Country
United States
Facility Name
Heartland Research Associates
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67207
Country
United States
Facility Name
Northshore Medical Research
City
Covington
State/Province
Louisiana
ZIP/Postal Code
70433
Country
United States
Facility Name
Institute for Asthma & Allergy, PC
City
Wheaton
State/Province
Maryland
Country
United States
Facility Name
Center for Clinical Research
City
Taunton
State/Province
Massachusetts
ZIP/Postal Code
02780
Country
United States
Facility Name
Henry Ford Hospital & Medical Centers
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Hurley Child and Adolescent Asthma Center
City
Flint
State/Province
Michigan
ZIP/Postal Code
45832
Country
United States
Facility Name
Clinical Research Institute
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55402
Country
United States
Facility Name
Allergy, Asthma, Immunology Services, LLC
City
Jefferson City
State/Province
Missouri
ZIP/Postal Code
65101
Country
United States
Facility Name
Midwest Chest Consultants, PC
City
St. Charles
State/Province
Missouri
ZIP/Postal Code
63301
Country
United States
Facility Name
Washington University School of Medicine, Division of Allergy & Immunology
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Montana Medical Research, LLC
City
Missoula
State/Province
Montana
ZIP/Postal Code
59804
Country
United States
Facility Name
Allergy, Asthma & Immunology Associates, PC
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68505
Country
United States
Facility Name
Heartland Clinical Research Inc.
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68134
Country
United States
Facility Name
Office of Meera Dewan, MD
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68144
Country
United States
Facility Name
Delaware Valley Institute for Clinical Research
City
Cherry Hill
State/Province
New Jersey
ZIP/Postal Code
08003
Country
United States
Facility Name
Clinical Research Center of Allergy & Asthma Consultants
City
Tinton Falls
State/Province
New Jersey
ZIP/Postal Code
07701
Country
United States
Facility Name
Lovelace Scientific Resources
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87108
Country
United States
Facility Name
Allergy & Asthma of Northern NM
City
Los Alamos
State/Province
New Mexico
ZIP/Postal Code
87544
Country
United States
Facility Name
Pulmonary Medical Research of NY
City
Bay Shore
State/Province
New York
ZIP/Postal Code
11706
Country
United States
Facility Name
Asthma & Allergy Associates, PC
City
Cortland
State/Province
New York
ZIP/Postal Code
13045
Country
United States
Facility Name
Office of Michael Marcus, MD
City
Staten Island
State/Province
New York
ZIP/Postal Code
10304
Country
United States
Facility Name
Office of Richard Castaldo
City
Tonawanda
State/Province
New York
ZIP/Postal Code
14150
Country
United States
Facility Name
Regional Allergy & Asthma Consultants
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
Charlotte Lung & Health Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Neem Research Group, Inc.
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28262
Country
United States
Facility Name
Cornerstone Research Care
City
High Point
State/Province
North Carolina
Country
United States
Facility Name
Carolina MedTrials, LLC
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Allergy & Asthma Care Center
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58104
Country
United States
Facility Name
Sterling Research Group
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
New Horizons Clinical Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45241
Country
United States
Facility Name
Optimed Research LLC
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43235
Country
United States
Facility Name
Allergy, Asthma & Clinical Research Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Facility Name
Allergy, Asthma and Dermatology Research Center
City
Lake Oswego
State/Province
Oregon
ZIP/Postal Code
97035
Country
United States
Facility Name
Medford Medical Clinic, LLP
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Bellevue Pediatric Associates
City
Bellevue
State/Province
Pennsylvania
ZIP/Postal Code
15202
Country
United States
Facility Name
Valley Clinical Research Center
City
Easton
State/Province
Pennsylvania
ZIP/Postal Code
18045
Country
United States
Facility Name
Allergy & Asthma Research of NJ, Inc.
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19115
Country
United States
Facility Name
Temple University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
Advanced Clinical Concepts
City
Shillington
State/Province
Pennsylvania
ZIP/Postal Code
19607
Country
United States
Facility Name
Neem Research Group of Charleston
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29407
Country
United States
Facility Name
Neem Research Group Inc.
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29201
Country
United States
Facility Name
Allergic Disease & Asthma Center, PA
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607
Country
United States
Facility Name
Asthma Institute
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
Facility Name
The Allergy Associates
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37917
Country
United States
Facility Name
Office of Constantine Saadeh
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79106
Country
United States
Facility Name
Allergy & Asthma Clinical of Central Texas
City
Austin
State/Province
Texas
ZIP/Postal Code
78749
Country
United States
Facility Name
UTX Medical
City
Galveston
State/Province
Texas
ZIP/Postal Code
00000
Country
United States
Facility Name
Breco Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Facility Name
Breath of Life Research Institute
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Facility Name
Clinical Trials of North Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77070
Country
United States
Facility Name
Central Texas Health Research
City
New Braunfels
State/Province
Texas
ZIP/Postal Code
78130
Country
United States
Facility Name
Lung Diagnostics
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Hampton Roads Center for Clinical Research
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Pulmonary Associates of Richmond Inc.
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23225
Country
United States
Facility Name
Virginia Adult & Pediatric Allergy & Asthma PC
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23229
Country
United States
Facility Name
National Clinical Research
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States
Facility Name
The Physician's Clinic of Spokane
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Allergy, Asthma, and Sinus Center F.C.
City
Greenfield
State/Province
Wisconsin
ZIP/Postal Code
53228
Country
United States
Facility Name
Milwaukee Medical Clinic
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53209
Country
United States
Facility Name
Allergic Diseases, S.C.
City
West Allis
State/Province
Wisconsin
ZIP/Postal Code
53227
Country
United States
Facility Name
Trial Management Group
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5K 1Z9
Country
Canada
Facility Name
St. Boniface General Hospital
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R2H 2A6
Country
Canada
Facility Name
Clinical Research Group
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5B 1N1
Country
Canada
Facility Name
Niagara Clinical Research, Inc.
City
Niagara Falls
State/Province
Ontario
ZIP/Postal Code
L2E 7H1
Country
Canada
Facility Name
Primary Care Lung Clinic
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6H 3M2
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Long Term Safety Study of Levalbuterol and Racemic Albuterol in Subjects Twelve Years of Age and Older With Asthma

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