Study of Levalbuterol, Racemic Albuterol and Placebo in Subjects Twelve Years of Age and Older With Asthma
An Efficacy and Safety Study of Levalbuterol, Racemic Albuterol and Placebo in Subjects Twelve Years of Age and Older With Asthma
1 other identifier
interventional
386
1 country
54
Brief Summary
The primary objective of this study is to investigate the efficacy of levalbuterol 90 ug (2 actuations, 45 ug each) versus placebo (2 actuations) in the treatment and prevention of bronchoconstriction in adolescent and adult subjects with asthma, with all treatments administered 4 times a day (QID).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 asthma
Started Dec 2002
Shorter than P25 for phase_3 asthma
54 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2003
CompletedFirst Submitted
Initial submission to the registry
December 9, 2003
CompletedFirst Posted
Study publicly available on registry
December 11, 2003
CompletedFebruary 22, 2012
February 1, 2012
6 months
December 9, 2003
February 21, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
FEV1 (peak percent change from pre-dose averaged over the double-blind period).
8 weeks
Secondary Outcomes (1)
--FEV1 [area under the % change from pre-dose FEV1 curve] and FEV1 [area under the % change from study baseline FEV1 curve]
9 weeks
Study Arms (3)
I
ACTIVE COMPARATORLevalbuterol 90 ųg QID (manufacturing site A or B)
II
ACTIVE COMPARATORRacemic Albuterol 180 ųg QID
III
PLACEBO COMPARATORPlacebo QID
Interventions
* Levalbuterol 90 ųg QID (manufacturing sites A or B); * Racemic Albuterol 180 ųg QID; * Placebo QID
Eligibility Criteria
You may qualify if:
- Must give written informed consent (IC) prior to participation in the study. For subjects 12 - 17 years of age, the IC must be signed parent or legal guardian. Females must sign the Women of Childbearing Potential Addendum
- Be willing and able to comply with the study procedures and visit schedules
- Male or female, at least 12 years of age
- Females 12-60 years of age must have a negative serum pregnancy test at Visit 1 (V1)
- Women of child bearing potential must be using an acceptable method of birth control
- Must have a documented diagnosis of asthma for a min. of 6 mos. prior to V1
- At V1, the subject must demonstrate a baseline FEV1 within \>45% and \<75% of predicted for their height, age, gender, and race
- Following abstention from medications used to treat asthma, subject must demonstrate \>12% reversibility of airflow obstruction within 15-30 min. following inhalation of 180 µg (2 actuations, 90 µg ea.) of racemic albuterol MDI
- Must have stable baseline asthma and have been using a B-adrenergic agonist, and/or anti-asthma anti-inflammatory medication, and/or OTC asthma medication for at least 6 mos. prior to V1
- Must be in good health with the exception of their reversible airways disease and not suffering from any chronic condition that might affect their respiratory function
- Must have a chest X-ray that is not diagnostic of pneumonia, atelectasis, pulmonary fibrotic disease, pneumothorax, chronic obstructive pulmonary disease, etc.
- Must be able to complete the diary cards and medical event calendars reliably on a daily basis and demonstrate how to use the MiniWright PEF meter
You may not qualify if:
- Subject who is expected to require any disallowed medications
- Female subject who is pregnant or lactating
- Subject who has participated in an investigational drug study within 30 days prior to V1, or who is currently participating in another clinical trial
- Schedule prevents him or her from taking the first daily dose of study medication and/or starting study visits before 9AM
- Subject who has travel commitments during the study that would interfere with trial measurements or compliance or both
- Subject who has a history of hospitalization for asthma within 45 days prior to V1, or who is scheduled for in-patient hospitalization during the trial
- Have 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 administration is contraindicated
- Subject with currently diagnosed life-threatening asthma
- Subject with clinically significant abnormalities that may interfere with the metabolism or excretion of the study drug
- Have a history of cancer (exception: basal cell carcinoma in remission)
- Have hyperthyroidism, diabetes, hypertension, cardiac diseases, or seizure disorders not well controlled by medication or that may interfere with the successful completion of this protocol
- Have a history of substance or drug abuse within 12 mos. preceding V1 or a positive urine drug screening at V1
- Have greater than 10 pack year history of cigarette smoking or use of any tobacco products within 6 mos. of V1
- Have a documented history of bronchopulmonary aspergillosis or any form of allergic alveolitis
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (54)
Allergy & Asthma Center, LLC
Oxford, Alabama, 36203, United States
Alta Clinical Research
Tucson, Arizona, 85745, United States
Integrated Research Group
Corona, California, 92879, United States
Radiant Research, Inc.
Encinitas, California, 92024, United States
Allergy & Asthma Specialists Medical Group
Huntington Beach, California, 92647, United States
Asthma, Allergy & Respiratory Care Center
Long Beach, California, 90808, United States
Allergy Research Foundation, Inc.
Los Angeles, California, 90025, United States
Madera Family Medical Group
Madera, California, 93637, United States
Southern California Research
Mission Viejo, California, 92691, United States
Comprehensive Allergy Services
Oakland, California, 94609, United States
Clinical Trials of Orange County
Orange, California, 92868, United States
Allergy Associates Medical Group
San Diego, California, 92120, United States
Allergy & Asthma Medical Group & Research Center
San Diego, California, 92123, United States
Allergy & Asthma Assoc. of Santa Clara Valley Research Center
San Jose, California, 95117, United States
West Coast Clinical Trials
Signal Hill, California, 90755, United States
Allergy & Asthma Medical Group of Diablo Valley, Inc.
Walnut Creek, California, 94598, United States
1st Allergy & Asthma Clinical Research Ctr
Thornton, Colorado, 80233, United States
Watts Medical Research
Barnesville, Georgia, 30204, United States
The Allergy & Asthma Clinical Research Center
Conyers, Georgia, 30013, United States
Aeroallergy Research Laboratories of Savannah, Inc.
Savannah, Georgia, 31406, United States
Rush Presbyterian - St. Luke's Medical Center Rush University
Chicago, Illinois, 60612, United States
South Bend Clniic
South Bend, Indiana, 46617, United States
Clinical Research Specialist
Metairie, Louisiana, 70006, United States
Doctor's Care
New Orleans, Louisiana, 70122, United States
Children's International Medical Research
Slidell, Louisiana, 70458, United States
Clinical Research Institute
Minneapolis, Minnesota, 55402, United States
The Clinical Research Center, LLC
St Louis, Missouri, 63141, United States
Heartland Clinical Research Inc.
Omaha, Nebraska, 68134, United States
Asthma & Allergy Center PC
Papillion, Nebraska, 68046, United States
Office of Yekaterina Khronusova, MD
Las Vegas, Nevada, 89119, United States
Pulmonary Medical Research of NY, PLLC
Bay Shore, New York, 11706, United States
Asthma & Allergy Associates PC
Cortland, New York, 13046, United States
AAIR Research Center
Rochester, New York, 14618, United States
Office or Richard Castaldo, MD
Tonawanda, New York, 14150, United States
Charlotte Lung and Health Center
Charlotte, North Carolina, 28207, United States
Albermarle Allergy & Asthma PC
Elizabeth City, North Carolina, 27909, United States
Piedmont Medical Research
Winston-Salem, North Carolina, 27103, United States
New Horizons Clinical Research, Inc.
Cincinnati, Ohio, 45241, United States
Allergy, Asthma & Clinical Research Center
Oklahoma City, Oklahoma, 73120, United States
Allergy Associates Research Center, LLC
Portland, Oregon, 97213, United States
Valley Clinical Research Center
Easton, Pennsylvania, 18045, United States
Advanced Clinical Concepts
Temple, Pennsylvania, 19560, United States
Allergic Disease & Asthma Center PA
Greenville, South Carolina, 29607, United States
Allergy & Asthma Consultants, LLP
Mt. Pleasant, South Carolina, 29464, United States
Allergy and Asthma Clinic of Central Texas
Austin, Texas, 78749, United States
Research Across America
Dallas, Texas, 75234, United States
Breco Research
Houston, Texas, 77024, United States
Breath of Life Research Institute
Houston, Texas, 77084, United States
Lung Diagnostics
San Antonio, Texas, 78229, United States
PI - Coor Clinical Research, LLC
Burke, Virginia, 22015, United States
Pulmonary Associates of Richmond, inc.
Richmond, Virginia, 23225, United States
Rockwood Clinics, PS
Spokane, Washington, 99220, United States
Allergy, Asthma and Sinus Center F.C.
Greenfield, Wisconsin, 53228, United States
Allergic Diseases, SC
West Allis, Wisconsin, 53227, United States
Related Publications (1)
Duan QL, Gaume BR, Hawkins GA, Himes BE, Bleecker ER, Klanderman B, Irvin CG, Peters SP, Meyers DA, Hanrahan JP, Lima JJ, Litonjua AA, Tantisira KG, Liggett SB. Regulatory haplotypes in ARG1 are associated with altered bronchodilator response. Am J Respir Crit Care Med. 2011 Feb 15;183(4):449-54. doi: 10.1164/rccm.201005-0758OC. Epub 2010 Sep 17.
PMID: 20851928DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
John Hanrahan, M.D.
Sumitomo Pharma America, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 9, 2003
First Posted
December 11, 2003
Study Start
December 1, 2002
Primary Completion
June 1, 2003
Study Completion
June 1, 2003
Last Updated
February 22, 2012
Record last verified: 2012-02