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Efficacy and Safety of Levalbuterol Versus Racemic Albuterol in Asthma

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ClinicalTrials.gov Identifier: NCT00667407
Recruitment Status : Completed
First Posted : April 28, 2008
Last Update Posted : February 22, 2012
Information provided by (Responsible Party):

Brief Summary:
To investigate the Efficacy and Safety of Levalbuterol versus Racemic Albuterol in the Treatment of Acute Asthma.

Condition or disease Intervention/treatment Phase
Asthma Drug: Levalbuterol 1.25 mg Drug: Racemic Albuterol Sulfate Phase 3

Detailed Description:
This study is a double-blind, randomized, active-controlled, multicenter, parallel-group trial of levalbuterol in adult subjects with acute reversible airways disease. Approximately 600 subjects will be enrolled and study participation will consist of 2 periods: Period I (Acute Period): Double-blind treatment in the Emergency Department (ED) or Clinic until disposition, for a maximum of 24 hours of double-blind treatment and Period II (Post-Acute Period): Subjects discharged from the ED or Clinic will continue double blind treatment (with the same treatment provided as rescue medication as MDI) for approximately 10 days. Subjects will be contacted by telephone 30 days post discharge to assess relapse. 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 627 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind Study to Determine the Efficacy of Levalbuterol Versus Racemic Albuterol in the Treatment of Acute Asthma
Study Start Date : November 2000
Actual Primary Completion Date : August 2002
Actual Study Completion Date : August 2002

Arm Intervention/treatment
Experimental: 1
Levalbuterol 1.25 mg
Drug: Levalbuterol 1.25 mg

levalbuterol 1.25 mg Period I: administered every 20 minutes for the first 3 doses, and then every 40 minutes for the next 3 doses; then as clinically indicated.

Period II: TID for 3 days (same time of day), then PRN to TID for 7 days

Other Name: Xopenex HCl Inhalation Solution

Active Comparator: 2
Racemic Albuterol 2.5 mg
Drug: Racemic Albuterol Sulfate

Racemic Albuterol 2.5 mg Period I: every 20 min for the first 3 doses, then every 40 min for the next 3 doses, then as clinically indicated.

Period II: TID for 3 days then PRN to TID for 7 days

Other Name: Ventolin Inhalation Solution

Primary Outcome Measures :
  1. Time to meet discharge criteria (functional airway improvement)during the first 3 hours of Period I. [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. FEV1 (Period I): Serial spirometry, maximum FEV1, time to maximum FEV1, baseline FEV1 severity on subject response; % responders, no. nebulizations to meet discharge criteria, rate of hospitalization, time to admit decision, rate for increased care [ Time Frame: Day 0 (5-10 min after every dose) ]
  2. FEV1 (Period II): Spirometry, average FEV1; distribution of subject responses; rate of relapse; blinded study medication; length of stay in ED or Clinic during Period I; length of hospitalization, cost of care [ Time Frame: Days 3, 10 ]
  3. Investigator and subject global evaluations, subject preference [ Time Frame: Days 3, 10 ]
  4. Subject reported beta-mediated side effects [ Time Frame: Days 3, 10 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male and female subjects must be at least greater than or equal to 18 years of age at the time of consent.
  • Subjects must have history of asthma for at least 6 months.
  • Subjects must present to the emergency department (ED) or clinic with forced expiratory volume in one second (FEV1) of 20 to 55% (inclusive) predicted at baseline
  • Subjects must have O2 saturation greater than or equal to 90% at room air or with no more than 6 Liters/minute supplemental oxygen and no other cause of wheezing or shortness of breath other than asthma as determined by the physician.
  • Prior use of a beta-agonist (e.g., Primatine Mist, albuterol, salmeterol, etc.) within 24 hours of presentation to the ED or Clinic.
  • Smoked ≤ 10 pack-years or non-smoker.
  • Be in good health with the exception of asthma and not suffering from any chronic condition which might affect their lung function, such as COPD or emphysema.
  • Near-normal activity level between exacerbations.
  • Subjects who are taking inhaled or systemic corticosteroids must be on a stable dose for at least 21 days prior to study entry.

Exclusion Criteria:

  • Subjects who have received treatment for asthma in an ED, Clinic, or Urgent Care Center within 2 weeks prior to study entry.
  • Based upon history or physical exam in the ED or Clinic, subjects with known or suspected cause of pulmonary symptoms other than asthma, such as COPD, CHF, pneumonia, pulmonary embolism, or angioedema.
  • Subjects with a history of asthma episodes associated with hypercapnia, respiratory arrest, hypoxic seizures, or requiring intubation within 12 months prior to entry.
  • Hospitalization for asthma within two months prior to entry.
  • Female subjects who are pregnant or lactating.
  • Subjects who have a history of a clinically significant psychiatric disorder within the last 3 months, with the exception of mild depression.
  • Subjects who have participated in an investigational drug study within 30 days of study entry or have previously participated in the current trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00667407

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United States, Alabama
Hoover, Alabama, United States
Montgomery, Alabama, United States
United States, California
Encinitas, California, United States
Fresno, California, United States
Oakland, California, United States
Torrance, California, United States
United States, Colorado
Colorado Springs, Colorado, United States
United States, Florida
Gainesville, Florida, United States
Jacksonville, Florida, United States
Tampa, Florida, United States
United States, Illinois
Chicago, Illinois, United States
United States, Louisiana
Metairie, Louisiana, United States
United States, Michigan
Ann Arbor, Michigan, United States
Detroit, Michigan, United States
United States, Missouri
Kansas City, Missouri, United States
St. Louis, Missouri, United States
United States, New Jersey
Red Bank, New Jersey, United States
United States, New York
Brooklyn, New York, United States
New Hyde Park, New York, United States
Syracuse, New York, United States
United States, North Carolina
Rocky Mount, North Carolina, United States
United States, Ohio
Akron, Ohio, United States
Cleveland, Ohio, United States
United States, Oregon
Lake Oswego, Oregon, United States
Medford, Oregon, United States
United States, Pennsylvania
Philadelphia, Pennsylvania, United States
United States, Texas
Houston, Texas, United States
United States, Utah
Salt Lake City, Utah, United States
Sponsors and Collaborators
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Responsible Party: Sunovion
ClinicalTrials.gov Identifier: NCT00667407    
Other Study ID Numbers: 051-915
First Posted: April 28, 2008    Key Record Dates
Last Update Posted: February 22, 2012
Last Verified: February 2012
Keywords provided by Sunovion:
Additional relevant MeSH terms:
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Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Pharmaceutical Solutions
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action