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Efficacy and Safety of Levalbuterol Versus Racemic Albuterol in Asthma

Information source: Sunovion
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Asthma

Intervention: Levalbuterol 1.25 mg (Drug); Racemic Albuterol Sulfate (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Sunovion


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

Clinical Details

Official title: A Randomized, Double-Blind Study to Determine the Efficacy of Levalbuterol Versus Racemic Albuterol in the Treatment of Acute Asthma

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Time to meet discharge criteria (functional airway improvement)during the first 3 hours of Period I.

Secondary outcome:

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

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

Investigator and subject global evaluations, subject preference

Subject reported beta-mediated side effects

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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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.

Locations and Contacts

Hoover, Alabama, United States

Montgomery, Alabama, United States

Encinitas, California, United States

Fresno, California, United States

Oakland, California, United States

Torrance, California, United States

Colorado Springs, Colorado, United States

Gainesville, Florida, United States

Jacksonville, Florida, United States

Tampa, Florida, United States

Chicago, Illinois, United States

Metairie, Louisiana, United States

Ann Arbor, Michigan, United States

Detroit, Michigan, United States

Kansas City, Missouri, United States

St. Louis, Missouri, United States

Red Bank, New Jersey, United States

Brooklyn, New York, United States

New Hyde Park, New York, United States

Syracuse, New York, United States

Rocky Mount, North Carolina, United States

Akron, Ohio, United States

Cleveland, Ohio, United States

Lake Oswego, Oregon, United States

Medford, Oregon, United States

Philadelphia, Pennsylvania, United States

Houston, Texas, United States

Salt Lake City, Utah, United States

Additional Information

Starting date: November 2000
Last updated: February 21, 2012

Page last updated: August 23, 2015

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